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Trials last updated: April 19, 2024

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1

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of NBTXR3, an experimental nanoparticle, and stereotaxic ablative radiotherapy, with nivolumab (Opdivo®) or pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the soft tissues, lungs, or liver. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3, by intratumoral injection, 1 time</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) or pembrolizumab (Keytruda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3 is an experimental nanoparticle designed to kill cancer cells that is activated by stereotaxic ablative radiotherapy.</li> <li class="seamTextUnorderedListItem">NBTXR3 will be injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy, also called stereotactic radiation or stereotactic radiosurgery, delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03589339' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nanobiotix.com/clinical-trials/' target='_blank'>Nanobiotix Drug Information Page: NBTXR3</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotaxic Ablative Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
1

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
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Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03589339

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Phase I

2

GSK4381562 Immunotherapy for Advanced Breast Cancer

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of GSK4381562 (SRF813), an experimental immunotherapy, alone and with dostarlimab (Jemperli®), a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813) is an experimental immunotherapy that targets PVRIG/SRF813 to activate immune cells to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05277051' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.surfaceoncology.com/news-releases/news-release-details/surface-oncology-achieves-30-million-milestone-first-patient' target='_blank'>Surface Oncology Press Release: First Patient Dosed with GSK4381562 (SRF813)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/jemperli' target='_blank'>Breastcancer.org: Dostarlimab (Jemperli®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li></ul>
2

GSK4381562 Immunotherapy for Advanced Breast Cancer

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors
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Nearest Location:
3 miles
GSK Investigational Site
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05277051

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Phase I

3

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)

Purpose: To look at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) or ER Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-04518600, by IV, every 2 weeks </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab, by IV, once a month</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bavencio is type of immunotherapy called a <span class="highlight">PD-L1</span> inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. </li> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03971409' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/avelumab' target='_blank'>NCI Drug Dictionary: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pf-04518600/' target='_blank'>Immuno-Oncology News: PF-04518600</a> </li><li class='seamTextUnorderedListItem'><a href='https://pfe-pfizercom-prod.s3.amazonaws.com/news/asco/Pfizer_IO_41BB_UtomilumabFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/binimetinib' target='_blank'>NCI Drug Dictionary: Binimetinib</a> </li></ul>
3

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)
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Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

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Visits:
1 visit every 2 weeks, ongoing

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ClinicalTrials.gov: NCT03971409

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Phase II

4

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors (ABILITY)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MDNA11, an experimental immunotherapy, alone and with a checkpoint inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Checkpoint inhibitor as determined by your physician</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11 is an experimental immunotherapy called interleukin-2 (IL-2).</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">A checkpoint inhibitor is a type of immunotherapy. It gets the immune system to go after cancer cells by blocking the protein <span class="highlight">PD-1.</li></span> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05086692' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medicenna.com/pipeline/mdna11/' target='_blank'>Medicenna Drug Information Page: MDNA11</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2021/12/22/2356750/0/en/Medicenna-Announces-Preliminary-Clinical-Data-Showing-Preferential-Stimulation-of-Anti-Cancer-Immune-Cells-with-MDNA11-Treatment-in-the-Phase-1-2-ABILITY-Study.html' target='_blank'>Medicenna Press Release: MDNA11 Treatment in the Phase 1/2 ABILITY Study</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cytokines' target='_blank'>Breastcancer.org: Interleukin-2</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/checkpoint-inhibitors' target='_blank'>Cancer Research UK: Checkpoint Inhibitors</a> </li></ul>
4

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors (ABILITY)
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Nearest Location:
3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05086692

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Phase I-II

5

Collecting Tumor Samples to Develop a Test to Predict Response to Treatment

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

Purpose: To collect tumor samples that will be used to develop OncoPrism™, a test that helps providers predict response to immunotherapy.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer who have received or are planning to receive treatment with a <span class="highlight">PD-1/PD-L1</span> inhibitor. You must have received a biopsy before beginning treatment with a <span class="highlight">PD-1/PD-L1</span> inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OncoPrism™ is a test that helps providers predict response to immunotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04510129' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cofactorgenomics.com/technology/' target='_blank'>Cofactor Genomics: OncoPrism™ Test</a> </li></ul>
5

Collecting Tumor Samples to Develop a Test to Predict Response to Treatment

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies
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Nearest Location:
3 miles
Curebase
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04510129

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Phase NA

6

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Metastatic Breast Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

Purpose: To study the safety, effects (good and bad), and best dose of DF1001 when it is given alone or with pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests HER2 1+, 2+ or 3+ on the IHC (immunohistochemistry) tumor test and have not had more than three lines of chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 immunotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">You may also receive:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 is an experimental immunotherapy. </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a <span class="highlight">PD-L1</span> inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04143711' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/msi-h/' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dragonflytx.com/copy-of-about-us-1' target='_blank'>Dragonfly Therapeutics Information Page: DF1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554437/' target='_blank'>Journal Article: Cancer Immunotherapy Based on Natural Killer Cells: Current Progress and New Opportunities</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/keytruda-approved-for-microsatellite-instability-high-and-mismatch-repair-deficient-cancers' target='_blank'>Cure Today: Keytruda Approved for Any Solid Tumor With a Specific Genetic Marker</a> </li></ul>
6

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Metastatic Breast Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
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Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04143711

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Phase I-II

7

Datopotamab Deruxtecan ADC for Metastatic Triple Negative Breast Cancer

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for <span class="highlight">PD-1/PD-L1</span> Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not received chemotherapy or targeted therapy for advanced disease. You must not have received treatment with trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®). You must have at least 1 tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy: paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), capecitabine (Xeloda®), paraplatin (Carboplatin®), or eribulin (Halaven®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), capecitabine (Xeloda®), paraplatin (Carboplatin®), or eribulin (Halaven®) are chemotherapy drugs.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05374512' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/february-10-2022/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Datopotamab Deruxtecan Shows Activity in Advanced Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastastic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
7

Datopotamab Deruxtecan ADC for Metastatic Triple Negative Breast Cancer

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for <span class="highlight">PD-1/PD-L1</span> Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)
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Nearest Location:
3 miles
Research Site
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05374512

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Phase III

8

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease

Purpose: To compare the safety and effects (good and bad) of giving immunotherapy along with chemotherapy versus giving chemotherapy alone to treat breast cancer that has spread to the chest wall.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that has spread to the chest wall and cannot be removed by surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is the immunotherapy drug used in this study. It is a <span class="highlight">PD-1</span> inhibitor approved to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is the chemotherapy used in this study.</li> <li class="seamTextUnorderedListItem">In this trial, researchers will test tumor biopsies and blood samples before and after treatment in order to learn more about how genes and the immune system affect how tumors respond to immunotherapy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03095352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.TPS1113' target='_blank'>ASCO Abstract: Pembrolizumab and Carboplatin</a> </li></ul>
8

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease
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Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

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Visits:
Visits every 3 weeks, ongoing

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ClinicalTrials.gov: NCT03095352

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Phase II

9

Trastuzumab Deruxtecan ADC and Pembrolizumab Immunotherapy for Advanced HER2 Positive and HER2 Low Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received trastuzumab emtansine/T-DM1 (Kadcyla®) or standard of care therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy directly to the cancer cells. It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking <span class="highlight">PD-1</span> allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042701' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer' target='_blank'>FDA: FDA Approves Fam-Trastuzumab Deruxtecan-nxki</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fam-trastuzumab-deruxtecan' target='_blank'>NCI Drug Dictionary: Fam-Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/february-2020/trastuzumab-deruxtecan-in-her2-low-expressing-previously-treated-advanced-breast-cancer/' target='_blank'>ASCO Post: Trastuzumab Deruxtecan in HER2–Low-Expressing, Previously Treated Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda)</a> </li></ul>
9

Trastuzumab Deruxtecan ADC and Pembrolizumab Immunotherapy for Advanced HER2 Positive and HER2 Low Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)
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Nearest Location:
3 miles
University of California San Francisco Medical Center
San Francisco, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT04042701

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Phase I

10

E-602 Immunotherapy for Advanced Breast Cancer

A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Cancers (GLIMMER-01)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of E-602, an experimental immunotherapy, alone and with pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602 is an experimental type of immunotherapy that allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05259696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://palleonpharma.com/pipeline/' target='_blank'>Palleon Pharmaceuticals Drug Information Page: E-602</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
10

E-602 Immunotherapy for Advanced Breast Cancer

A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Cancers (GLIMMER-01)
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Nearest Location:
27 miles
Stanford Health Care
Stanford, CA

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Visits:
1 visit every week

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ClinicalTrials.gov: NCT05259696

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Phase I-II

11

HMBD-002 Immunotherapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of HMBD-002, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) <span class="highlight">PD-L1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002 is an experimental immunotherapy that targets a protein called VISTA and may increase the immune system's ability to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05082610' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://hummingbirdbioscience.com/hmbd-002/' target='_blank'>Hummingbird Bioscience: HMBD-002 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.precisiononcologynews.com/cancer/hummingbird-bioscience-merck-study-hmbd-002-keytruda-various-solid-tumors' target='_blank'>Precision Oncology News: HMBD-002</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
11

HMBD-002 Immunotherapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies
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Nearest Location:
28 miles
Stanford Cancer Institute
Palo Alto, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05082610

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Phase I

12

BDC-1001 With or Without Keytruda for People With Advanced HER2 Positive Breast Cancer

Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and HER2-Expressing Solid Tumors

Purpose: To study the anti-cancer activity and effects (good and bad) of giving the new immunotherapy drug BDC-1001 alone and with the <span class="highlight">PD-1</span> inhibitor pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no other treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> This is a 2-part study. Depending upon which part of the trial is open when you enroll, you will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001 is an investigational drug called an Immune Stimulating Antibody Conjugate. It combines an anti-HER2 drug with a drug that targets the TLR7/8 proteins. </li> <li class="seamTextUnorderedListItem">Researchers think targeting the TLR7/8 proteins can help make tumors more likely to respond to pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Pembrolizumab is another type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. It works by getting the immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04278144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://boltbio.com/#ourscience' target='_blank'>Drug Company Information Page: BDC-1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytru' target='_blank'>Merck Oncology: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nationalbreastcancer.org/breast-cancer-targeted-therapy' target='_blank'>National Breast Cancer Foundation: Targeted Therapy (Monoclonal Antibodies)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Immune_stimulating_antibody_conjugate' target='_blank'>Wikipedia: Immune Stimulating Antibody Conjugate</a> </li></ul>
12

BDC-1001 With or Without Keytruda for People With Advanced HER2 Positive Breast Cancer

Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and HER2-Expressing Solid Tumors
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Nearest Location:
28 miles
Stanford University
Palo Alto, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04278144

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Phase I-II

13

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced <span class="highlight">PD-L1</span> Positive, Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express <span class="highlight">PD-L1</span> (ASCENT-04)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan-hziy (Trodelvy®), a type of targeted therapy called an antibody drug conjugate (ADC), with pembrolizumab (Keytruda®), a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, compared to chemotherapy with pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">PD-L1</span> positive <span class="highlight">(PD-L1+),</span> triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: ADC with Immunotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Chemotherapy with Immunotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> or </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) with carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> with: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an experimental type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">PD-L1</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05382286' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy#:~:text=Trodelvy%20(chemical%20name%3A%20sacituzumab%20govitecan,two%20or%20more%20systemic%20therapies.' target='_blank'>Breastcancer.org: Sacituzumab govitecan-hziy (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation: Home</a> </li></ul>
13

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced <span class="highlight">PD-L1</span> Positive, Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express <span class="highlight">PD-L1</span> (ASCENT-04)
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Nearest Location:
53 miles
St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare
Santa Rosa, CA

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Visits:
1 visit every 2-3 weeks

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ClinicalTrials.gov: NCT05382286

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Phase III

14

Single vs. Multiple Doses of Radiation with Immunotherapy for Breast Cancer with Brain Metastasis

Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of single fraction stereotactic radiosurgery (SSRS) compared to fractionated stereotactic radiosurgery (FSRS).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have received or are receiving treatment with a <span class="highlight">PD-1/PD-L1</span> inhibitor. You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Single Radiation Dose</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single fraction stereotactic radiosurgery (SSRS), 1 time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Multiple Radiation Doses</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS), 3-5 times within 3-10 days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Single fraction stereotactic radiosurgery (SSRS) uses a higher dose of radiation in a single dose.</li> <li class="seamTextUnorderedListItem">SSRS has recently become a standard of care treatment for people with 1-4 brain metastases and is also commonly used for people with up to 15 metastases.</li> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS) uses a lower dose of radiation over 3 to 5 treatments given daily or every other day.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05703269' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiation</a> </li></ul>
14

Single vs. Multiple Doses of Radiation with Immunotherapy for Breast Cancer with Brain Metastasis

Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE)
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Nearest Location:
71 miles
Aspirus Cancer Care - Wisconsin Rapids
Sacramento, CA

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Visits:
1-5 visits within 1-2 weeks

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ClinicalTrials.gov: NCT05703269

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Phase NA

15

ASTX727 DNMT Inhibitor with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer

Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ASTX727, an experimental DNA methyltransferase (DNMT) inhibitor, with paclitaxel (Taxol®) chemotherapy and pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cedazuridine/Decitabine (ASTX727), by mouth</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Biopsies, 2 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cedazuridine/Decitabine (ASTX727) is an experimental targeted therapy called a DNA methyltransferase (DNMT) inhibitor. It is a combination of two drugs, decitabine and cedazuridine.</li> <li class="seamTextUnorderedListItem">Cedazuridine prevents decitabine from degrading in the body so that decitabine will work better.</li> <li class="seamTextUnorderedListItem">Decitabine helps bone marrow produce normal blood cells and kill abnormal cells in the bone marrow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug that stops tumor cells from growing and dividing and may kill them.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> helps the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05673200' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/oral-decitabine-and-cedazuridine-astx727-hematological-malignancies/' target='_blank'>Astex Pharmaceuticals: ASTX727 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
15

ASTX727 DNMT Inhibitor with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer

Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer
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Nearest Location:
74 miles
University of California Davis Comprehensive Cancer Center
Sacramento, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05673200

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Phase I

16

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is <span class="highlight">PD-L1</span> Negative

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study the safety and anti-cancer activity of giving chemotherapy, the immunotherapy tremelimumab, and the <span class="highlight">PD-L1</span> inhibitor Durvalumab (Imfinzi®) together with or without a personalized synthetic long peptide (SLP) vaccine and Hiltonol® (poly-ICLC) .

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is <span class="highlight">PD-L1</span> negative and who have not yet received any treatment for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Vaccine</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized SLP Vaccine and Hiltonol® (poly-ICLC), 7 times over 2.5 months</li> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: No Vaccine</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of vaccine used in this trial is called a personalized synthetic long peptide (SLP) vaccine. It may help your immune system see and fight cancer cells. </li> <li class="seamTextUnorderedListItem">Hiltonol® (poly-ICLC) is an immune cell activating factor.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy routinely used to treat advanced and metastatic triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tremelimumab is a type of immunotherapy called a CTLA-4 inhibitor.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a <span class="highlight">PD-L1</span> (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03606967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search/Personalized%20Synthetic%20Long%20Pe/?searchMode=Begins' target='_blank'>NCI Drug Dictionary: Personalized Synthetic Long Peptide Breast Cancer Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com' target='_blank'>Oncovir Drug Information Page: Hiltonol® (poly-ICLC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Tremelimumab' target='_blank'>Wikipedia: Tremelimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/durvalumab' target='_blank'>NCI Drug Dictionary: Durvalumab (Imfinzi®)</a> </li></ul>
16

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is <span class="highlight">PD-L1</span> Negative

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
74 miles
University of California Davis Comprehensive Cancer Center
Sacramento, CA

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Visits:
Number of visits varies, ongoing

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ClinicalTrials.gov: NCT03606967

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Phase II

17

SGN-PDL1V Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of SGN-PDL1V, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Its antibody targets <span class="highlight">PD-1/PD-L1,</span> a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called vedotin.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05208762' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clinicaltrials.seagen.com/study/?pid=SGNPDL1V-001' target='_blank'>Seagen Trial Information Page: SGN-PDL1V</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.seagen.com/press-releases/news-details/2021/Seagen-to-Highlight-Two-Novel-Antibody-Drug-Conjugates-ADCs-at-the-SITC-36th-Annual-Meeting/default.aspx' target='_blank'>Seagen Press Release: SGN-PDL1V</a> </li></ul>
17

SGN-PDL1V Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
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Nearest Location:
74 miles
University of California Davis
Sacramento, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05208762

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Phase I

18

BMS-986340 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BMS-986340, an experimental CCR8 inhibitor, alone or with nivolumab (Opdivo®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. You must have received at least 1 <span class="highlight">PD-1</span> inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340 is an experimental immunotherapy called a CCR8 inhibitor. BMS-986340 blocks the activity of CCR8 on immune cells to activate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04895709' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bolderscience.com/trial/NCT04895709/' target='_blank'>Bristol-Myers Squibb: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bmsscience.com/?s=BMS-986340+%26plusmn%3B+Nivolumab&search_cat=bms' target='_blank'>Bristol-Myers Squibb: BMS-986340 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bms.com/assets/bms/us/en-us/pdf/CCR8-Immune-Pathway-Fact-Sheet.pdf' target='_blank'>Bristol-Myers Squibb: CCR8 Immune Pathway</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-ccr8-monoclonal-antibody-bms-986340?redirect=true' target='_blank'>National Cancer Institute: BMS-986340 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://chemocare.com/chemotherapy/drug-info/opdivo.aspx' target='_blank'>Chemocare: Nivolumab (Opdivo®)</a> </li></ul>
18

BMS-986340 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
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Nearest Location:
164 miles
Community Cancer Institute
Clovis, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04895709

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Phase I-II

19

Sacituzumab Govitecan-hziy ADC for Advanced Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express <span class="highlight">PD-L1</span> or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do E... (ASCENT-03)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan-hziy (Trodelvy®), a type of targeted therapy called an antibody drug conjugate (ADC), compared to chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and have not received treatment with sacituzumab govitecan-hziy (Trodelvy®). If your cancer is <span class="highlight">PD-L1</span> positive, you must have previously received treatment with a <span class="highlight">PD-1/PD-L1</span> inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> or </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) with carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">PD-L1</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05382299' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy#:~:text=Trodelvy%20(chemical%20name%3A%20sacituzumab%20govitecan,two%20or%20more%20systemic%20therapies.' target='_blank'>Breastcancer.org: Sacituzumab govitecan-hziy (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation: Home</a> </li></ul>
19

Sacituzumab Govitecan-hziy ADC for Advanced Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express <span class="highlight">PD-L1</span> or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do E... (ASCENT-03)
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Nearest Location:
198 miles
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
San Luis Obispo, CA

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Visits:
1 visit every 2-3 weeks

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ClinicalTrials.gov: NCT05382299

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Phase III

20

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of XmAb808, an experimental bispecific antibody, with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb808</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb808 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">XmAb808 is a bispecific antibody that targets B7-H3 and CD28.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05585034' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://xencor.com/pipeline/' target='_blank'>Xencor Drug Information Page: XmAb808</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
20

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors
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Nearest Location:
336 miles
UCLA Hematology/Oncology
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05585034

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Phase I

21

KVA12123 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Open-label Trial of KVA12123 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of KVA12123, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) immune checkpoint inhibitor.

Who is this for?: Postmenopausal women and men with advanced (some stage III) or advanced (stage IV) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123, by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 1.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging scans, every 1.5 months</li> <li class="seamTextUnorderedListItem">Physical exams</li> <li class="seamTextUnorderedListItem">Heart function tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123 is an experimental immunotherapy that binds to VISTA to stimulate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05708950' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://kinetabio.com/kva12123/' target='_blank'>Kineta: KVA12123 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
21

KVA12123 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Open-label Trial of KVA12123 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
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Nearest Location:
339 miles
UCLA Health (Santa Monica Cancer Care)
Santa Monica, CA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT05708950

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Phase I-II

22

NGM707 With or Without Pembrolizumab in Advanced or Metastatic Breast Cancer

A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Purpose: To study the safety, best dose and effects (good and bad) of NGM707 when given with and without Pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no other treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to one of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM707, by IV, every 3 weeks </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM707, by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM707 is designed to improve immune responses to tumors.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04913337' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/ngm-bio-announces-initiation-of-phase-1-2-clinical-study-of-ngm707-for-the-treatment-of-advanced-solid-tumors/' target='_blank'>NGM Bio Press Release: NGM707</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/?preview_id=1346&preview_nonce=680d60f386&post_format=standard&_thumbnail_id=252&preview=true' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>
22

NGM707 With or Without Pembrolizumab in Advanced or Metastatic Breast Cancer

A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
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Nearest Location:
339 miles
UCLA Medical Center
Santa Monica, CA

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Visits:
1 visit every 3 weeks, ongoing

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ClinicalTrials.gov: NCT04913337

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Phase I-II

23

NGM831 with Pembrolizumab for Advanced Breast Cancer

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of NGM831, an experimental immunotherapy, alone and with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831 is an experimental immunotherapy called an ILT3 inhibitor.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking ILT3 and <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05215574' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.ngmbio.com/news-releases/news-release-details/ngm-bio-discloses-fourth-oncology-development-candidate-ngm831' target='_blank'>NGM Bio Press Release: NGM831</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
23

NGM831 with Pembrolizumab for Advanced Breast Cancer

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
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Nearest Location:
339 miles
NGM Clinical Study Site
Los Angeles, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05215574

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Phase I

24

TNG260 Targeted Therapy with Immunotherapy for Advanced Breast Cancer with STK11 Mutations

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of TNG260, an experimental targeted therapy, with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with STK11 mutations. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG260, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG260 is an experimental targeted therapy called a CoREST inhibitor. CoREST inhibitors may activate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: STK11</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05887492' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/pipeline/' target='_blank'>Tango Therapeutics: TNG260 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/programs/corest/' target='_blank'>Tango Therapeutics: CoREST Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
24

TNG260 Targeted Therapy with Immunotherapy for Advanced Breast Cancer with STK11 Mutations

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors
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Nearest Location:
339 miles
UCLA Hematology/Oncology
Santa Monica, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05887492

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Phase I-II

25

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BMS-986449, an experimental cancer drug, with and without nivolumab (Opdivo®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986449</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986449</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986449 is an experimental cancer drug.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05888831' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bmsstudyconnect.com/no/en/clinical-trials/NCT05888831.html' target='_blank'>Bristol-Myers Squib: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a614056.html' target='_blank'>MedLine Plus: Nivolumab (Opdivo®)</a> </li></ul>
25

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
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Nearest Location:
339 miles
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05888831

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Phase I-II

26

Keytruda for Advanced BRCA+ Breast Cancer

Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Advanced BRCA-mutated Breast Cancers

Purpose: To look at the safety and effects (good and bad) of using the immunotherapy drug pembrolizumab (Keytruda®) to treat advanced or metastatic breast cancer in patients with a BRCA mutation.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer and have been tested and told that you have an inherited BRCA (BRCA1 or BRCA2) mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein <span class="highlight">PD-1.</li></span> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of cancers, including breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03025035' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet' target='_blank'>NCI: BRCA1 and BRCA2</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li></ul>
26

Keytruda for Advanced BRCA+ Breast Cancer

Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Advanced BRCA-mutated Breast Cancers
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Nearest Location:
341 miles
Cedars-Sinai Medical Center
Los Angeles, CA

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Visits:
1 visit every 3 weeks, ongoing

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ClinicalTrials.gov: NCT03025035

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Phase II

27

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of LCB84, an experimental antibody drug conjugate (ADC), with or without a <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">PD-1</span> inhibitor, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">LCB84's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called MMAE.</li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called immune checkpoint inhibitors. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05941507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/checkpoint-inhibitors' target='_blank'>National Cancer Institute: Immune Checkpoint Inhibitors</a> </li></ul>
27

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors
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Nearest Location:
341 miles
Cedars Sinai Medical Center
Los Angeles, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05941507

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Phase I-II

28

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in <span class="highlight">PD-L1</span> Negative TNBC

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ivermectin (Stromectol®), an experimental anti-cancer drug, with balstilimab, an experimental immunotherapy.

Who is this for?: People with metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have received 1-2 lines of chemotherapy or antibody-drug conjugate (ADC) for metastatic disease. You must not have received treatment with pembrolizumab (Keytruda®) or dostarlimab (Jemperli®) for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ivermectin (Stromectol®), by mouth, 3 days every week</li> <li class="seamTextUnorderedListItem">Balstilimab, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ivermectin (Stromectol®) is an anti-parasite medicine that may also help block the formation of growths that may become cancer. In this trial, ivermectin (Stromectol®) is considered experimental.</li> <li class="seamTextUnorderedListItem">Bastilimab is an experimental immunotherapy called a CTLA-4 inhibitor, which is a type of immune checkpoint inhibitor. Blocking CTLA-4 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Giving ivermectin with balstilimab may increase the ability of balstilimab to shrink tumors in people with triple negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05318469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/breakthroughs/drug-combo-shows-promise-against-triple-negative-breast-cancer' target='_blank'>City of Hope: The Effect of Ivermectin and Bastilimab Together on Enhancing the Immune System's Ability to Kill Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20954-ivermectin-tablets' target='_blank'>Cleveland Clinic: Ivermectin (Stromectol®)</a> </li></ul>
28

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in <span class="highlight">PD-L1</span> Negative TNBC
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Nearest Location:
341 miles
Cedars-Sinai Medical Center
Los Angeles, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05318469

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Phase I-II

29

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of PC14586, an experimental p53 reactivator, alone or with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a TP53 Y220C mutation who have received at least 1 line of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586 is an experimental targeted therapy called a p53 reactivator which may stop the mutated p53 protein from working and cause cancer cell death.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53 Y220C</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04585750' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pmvpharma.com/pipeline/' target='_blank'>PMV Pharmaceuticals: PC14586 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
29

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE)
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Nearest Location:
348 miles
USC Norris Comprehensive Cancer Center
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04585750

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Phase I-II

30

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is <span class="highlight">PD-L1</span> Positive

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (KEYVIBE-005)

Purpose: To study the effects and anti-cancer activity of MK-7684A, an experimental combination immunotherapy containing pembrolizumab and vibostolimab, alone and in combination with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-), <span class="highlight">PD-L1</span> positive breast cancer who have not received treatment with pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">5-fluorouracil (Fluracil®), by IV, for 5 consecutive days every 3 weeks</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-7684A is an experimental combination immunotherapy containing pembrolizumab and vibostolimab.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Vibostolimab is an experimental type of immunotherapy called a TIGIT inhibitor. Blocking TIGIT may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">5-fluorouracil (Fluracil®), cisplatin (Platinol®), and paclitaxel (Taxol®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05007106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/vibostolimab-pembrolizumab-mk-7684a?redirect=true' target='_blank'>National Cancer Institute: MK-7684A</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.annalsofoncology.org/article/S0923-7534(21)04776-1/fulltext' target='_blank'>Journal Article: Vibostolimab as Monotherapy or With Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/' target='_blank'>Merck Drug Information Page: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
30

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is <span class="highlight">PD-L1</span> Positive

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (KEYVIBE-005)
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Nearest Location:
353 miles
City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte, CA

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Visits:
1-5 visits per month

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ClinicalTrials.gov: NCT05007106

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Phase II

31

Oncolytic Virus Alone or With Pembrolizumab for People with Advanced Breast Cancer

A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).(VAXINIA)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of CF33-hNIS, an experimental oncolytic virus, alone or with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 2 lines of therapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS, by injection or IV, 2 times in 3 weeks, then every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS, by injection or IV, 2 times in 3 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS is an experimental immunotherapy called an oncolytic virus. Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05346484' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imugene.com/oncolytic-virus' target='_blank'>Imugene: CF33-hNIS Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute: Oncolytic Viruses</a> </li></ul>
31

Oncolytic Virus Alone or With Pembrolizumab for People with Advanced Breast Cancer

A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).(VAXINIA)
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05346484

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Phase I

32

TAK-500 ADC with Pembrolizumab for Advanced Triple Negative Breast Cancer

An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of TAK-500, an experimental type of targeted therapy called an antibody drug conjugate (ADC), with pembrolizumab (Keytruda®), a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAK-500, by IV, every 2 or 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAK-500 is an experimental type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Its antibody targets and activates STING, a pathway that activates the immune system to attack cancer cells, and it delivers an anti-cancer drug called TAK-676.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05070247' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.takeda.com/49c795/siteassets/system/investors/investor--events/asco-2021-ir-event_en.pdf' target='_blank'>Takeda Drug Information Presentation (Slide 23): TAK-500</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
32

TAK-500 ADC with Pembrolizumab for Advanced Triple Negative Breast Cancer

An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
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Nearest Location:
353 miles
City of Hope Comprehensive Cancer Center
Duarte, CA

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Visits:
At least every 3 weeks

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ClinicalTrials.gov: NCT05070247

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Phase I-II

33

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib

Purpose: To study the anti-cancer activity and effects (good and bad) of adding the immunotherapy drug pembrolizumab (Keytruda®) to the commonly used combination of the anti-estrogen drug letrozole (Femara®) and the CDK 4/6 inhibitor palbociclib (Ibrance®).

Who is this for?: Women with metastatic (stage IV) estrogen receptor positive (ER+) HER2 negative (HER2-) breast cancer who have not yet started treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and palbociclib (Ibrance®) are an already approved therapy combination. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is an anti-estrogen therapy. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein <span class="highlight">PD-1.</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02778685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com' target='_blank'>Pfizer Oncology Drug Information Page: Ibrance® (Palbociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwycfkBRAFEiwAnLX5IZ2WUInCzwQ56GHMYYq-KXijoX1dzOK1O8HBbmaxajT0CPi2CbX3sRoC3A4QA' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/the-evolving-field-of-erpositive-metastatic-breast-cancer-care' target='_blank'>Cure Today: The Evolving Field of ER Positive-Metastatic BC</a> </li></ul>
33

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
Every 3 weeks, ongoing

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ClinicalTrials.gov: NCT02778685

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Phase II

34

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)

Purpose: To study the safety and effects (good and bad) of 7 different immunotherapy-based treatment combinations in people with triple negative (ER-/PR-/HER2-) breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 7 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 7</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Physician's choice chemotherapy (gemcitabine/Gemzar® plus carboplatin/Paraplatin®, or eribulin/Halaven®), by IV, weekly (2 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a <span class="highlight">PD-L1</span> inhibitor that works by stimulating the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq is approved to treat certain types of urinary, bladder and lung cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®).</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03424005' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li></ul>
34

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)
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Nearest Location:
353 miles
City of Hope
Duarte, CA

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT03424005

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Phase I-II

35

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, <span class="highlight">PD-L1</span> Positive Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind Study of RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, <span class="highlight">PD-L1-Positive,</span> Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RO7247669, an experimental targeted therapy, with nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is <span class="highlight">PD-L1</span> positive. You must have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669 is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">RO7247669 is a bispecific antibody that targets <span class="highlight">PD-1</span> (programmed death-1) and LAG-3 (lymphocyte-activation gene 3).</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05852691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tobemstomig' target='_blank'>National Cancer Institute: Tobemstomig (RO7247669)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-Paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
35

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, <span class="highlight">PD-L1</span> Positive Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind Study of RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, <span class="highlight">PD-L1-Positive,</span> Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
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Nearest Location:
366 miles
Cancer Blood and Specialty Clinic
Los Alamitos, CA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT05852691

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Phase II

36

BT5528 Alone or With Nivolumab in Advanced Triple Negative Breast Cancer That Tests EphA2+

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

Purpose: To study the safety, effects (good and bad), and best dose of an experimental therapy called BT5528 when it is given alone or with nivolumab (Opdivo®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-), have already tried other cancer treatments, have no other standard treatment options, and have a tumor that tests positive for a protein called EphA2. View full eligibility criteria

What's involved?

<p class="seamTextPara"> This trial is being conducted in two parts. You will participate in 1 of 2 parts depending on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once every 4 weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528 targets a protein called EphA2 that helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">EphA2 is found on some triple negative breast tumors. </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called <span class="highlight">PD-1</span> (programmed cell death 1). It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04180371' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Information Page: BT5528</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/onc2017170' target='_blank'>Journal Article: Targeting EphA2 In Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com/about-opdivo/how-opdivo-works-monotherapy' target='_blank'>Bristol-Meyers Squibb Information Page: Opdivo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/publications/cure/2019/immunotherapy-2019/breast-cancer-gets-a-boost-from-immunotherapy' target='_blank'>Cure Today: Breast Cancer Gets a Boost From Immunotherapy</a> </li></ul>
36

BT5528 Alone or With Nivolumab in Advanced Triple Negative Breast Cancer That Tests EphA2+

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression
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Nearest Location:
374 miles
University of California - Irvine Medical Center
Orange, CA

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Visits:
1 visit a week, ongoing

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ClinicalTrials.gov: NCT04180371

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Phase I-II

37

TBio-4101 TIL Therapy with Pembrolizumab Immunotherapy for Advanced Breast Cancer

A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of TBio-4101, an experimental tumor infiltrating lymphocyte (TIL) therapy, with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received standard treatment. View full eligibility criteria

What's involved?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101</li> <li class="seamTextUnorderedListItem">IL-2</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 3 weeks for 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101 is an experimental immunotherapy called tumor infiltrating lymphocyte (TIL) therapy.</li> <li class="seamTextUnorderedListItem">TBio-4101 is made by collecting, growing, and modifying specialized immune cells that are collected from your tumor. The immune cells may recognize, target, and kill the tumor cells.</li> <li class="seamTextUnorderedListItem">Before you receive the immune cells, you will be treated with the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). This is to prepare your body to receive the enhanced immune cells.</li> <li class="seamTextUnorderedListItem">IL-2 is a type of immunotherapy that activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05576077' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://turnstonebio.com/#our-science' target='_blank'>Turnstone Biologics: TBio-4101 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-targeted-therapies' target='_blank'>Breastcancer.org: Tumor Infiltrating Lymphocyte (TIL) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
37

TBio-4101 TIL Therapy with Pembrolizumab Immunotherapy for Advanced Breast Cancer

A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)
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Nearest Location:
374 miles
University of California Irvine
Irvine, CA

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Visits:
May require hospitalization; 1 visit every 3 weeks for 2 years

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ClinicalTrials.gov: NCT05576077

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Phase I

38

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA)

Purpose: To look at the safety and effects (good and bad) of the combination of durvalumab (Imfinzi®) and paclitaxel (Taxol®) when used alone or with one of three additional therapies.

Who is this for?: Women with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) being treated for the first time for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Capivasertib (AZD5363), by mouth, twice a day, 3 weeks on and 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Danvatirsen (AZD9150), by IV, 3 times in the first week and then weekly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Oleclumab (MEDI9447), by IV, once every 2 weeks for 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy called a <span class="highlight">PD-L1</span> (programmed cell death ligand-1) inhibitor. It has been approved to treat certain types of cancers, and its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxol is a chemotherapy routinely used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">The three additional therapies are capivasertib, a targeted therapy that blocks Akt; danvatirsen, a targeted therapy that blocks the STAT3 protein; and oleclumab, which targets CD73.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742102' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>OncLive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/stat3-antisense-oligonucleotide-isis-481464' target='_blank'>NCI Drug Dictionary: Danvatirsen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd73-monoclonal-antibody-medi9447' target='_blank'>NCI Drug Dictionary: Oleclumab</a> </li></ul>
38

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA)
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Nearest Location:
437 miles
Research Site
Eugene, OR

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Visits:
Approximately 1 visit a week

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ClinicalTrials.gov: NCT03742102

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Phase I-II

39

Olaparib and Durvalumab in Metastatic Triple Negative & ER Low Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To evaluate the safety and effects (good and bad) of using the combination of olaparib (Lynparza®) and durvalumab (Imfinzi®).

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily for 1 month, then once a month for 1 year</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly, for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2-3 tumor biopsies</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of ovarian cancer. </li> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy drug called a <span class="highlight">PD-L1</span> inhibitor. It gets the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of lung cancer. </li> <li class="seamTextUnorderedListItem">Preclinical studies suggest this drug combination may be effective in patients with metastatic triple negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03801369' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ex&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>Durvalumab (Imfinzi®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html?source=lyn_d_c_2&umedium=cpc&uadpub=google&ucampaign=lynparzadtcbranded_alone_2019&ucreative=branded_alone_ex&uplace=olapariblynparza&outcome=dtc&cmpid=1' target='_blank'>Olaparib (Lynparza®) Drug Information Page</a> </li></ul>
39

Olaparib and Durvalumab in Metastatic Triple Negative & ER Low Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
533 miles
OHSU Knight Cancer Institute
Portland, OR

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Visits:
Monthly visits for 1 year

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ClinicalTrials.gov: NCT03801369

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Phase II

40

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Purpose: To study the safety, anti-cancer activity and effects (good and bad) of SNS-101, an experimental immunotherapy, with or without cemiplimab, an experimental immunotherapy, in people with advanced breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SNS-101, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> with or without: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cemiplimab, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SNS-101 is an anti-VISTA IgG1 monoclonal antibody. SNS-101 is an immune checkpoint inhibitor that may help other immunotherapies work better.</li> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®) is a type of immunotherapy called an immune checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein <span class="highlight">PD-1.</span> Cemiplimab is approved by the FDA for other cancers but it considered experimental for breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05864144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.senseibio.com/wp-content/uploads/2022/05/SITC2022.pdf' target='_blank'>Sensei Biotherapeutics research poster: SNS-101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/cemiplimab-rwlc' target='_blank'>National Cancer Institute: Cemiplimab</a> </li></ul>
40

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
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Nearest Location:
595 miles
START Mountain Region
West Valley City, UT

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05864144

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Phase I-II

41

BAY3375968 Immunotherapy with <span class="highlight">PD-1</span> Inhibitor for Advanced Triple Negative Breast Cancer

First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BAY3375968, an experimental immunotherapy, with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAY3375968, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAY3375968 is an experimental immunotherapy called a CCR8 inhibitor. mBAY3375968 binds to CCR8 on immune cells which allows the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05537740' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Abstract: BAY3375968</a> </li><li class='seamTextUnorderedListItem'><a href='https://aacrjournals.org/cancerres/article/82/12_Supplement/2866/704369' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
41

BAY3375968 Immunotherapy with <span class="highlight">PD-1</span> Inhibitor for Advanced Triple Negative Breast Cancer

First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors
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Nearest Location:
595 miles
South Texas Accelerated Research Therapeutics | START Rocky Mountain Region
West Valley City, UT

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Visits:
5 visits within 1 week, then 1-3 visits per month

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ClinicalTrials.gov: NCT05537740

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Phase I

42

Personalized Vaccine with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine with immunotherapy.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received at least 1 line of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly for 2 weeks</li> </ul> <p class="seamTextPara"> followed 2 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> followed 6 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy. The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Poly ICLC is an immunotherapy that stimulates your immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05098210' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
42

Personalized Vaccine with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma
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Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
1 visit every week for 6 months, then 1 visit every 2-4 weeks

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ClinicalTrials.gov: NCT05098210

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Phase I

43

Niraparib and Dostarlimab for BRCA+ Advanced Breast Cancer

Phase IB Trial of Niraparib and TSR-042 in Patients With BRCA-Mutated Breast, Pancreas or Ovary Cancer

Purpose: To study the anti-cancer activity of giving niraparib, a PARP inhibitor, and dostarlimab (TSR-042), an immunotherapy, together.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1 or BRCA2 mutation. The BRCA1 or BRCA2 mutation can be hereditary (genetic) or tumor-based (genomic). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (TSR-042, Jemperli®), by IV, every 3 weeks (4 times), then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. </li> <li class="seamTextUnorderedListItem">Dostarlimab (TSR-042, Jemperli®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1 or BRCA2 hereditary (genetic) or tumor-based (genomic)</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04673448' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/genetic-vs-genomic-testing/' target='_blank'>Metastatic Trial Talk: Genetic vs. Genomic Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/dostarlimab-gains-new-fda-approved-indication-mismatch-repair-deficient-tumors' target='_blank'>CancerNetwork: Dostarlimab Gains New FDA-Approved Indication for Treatment of Mismatch Repair–Deficient Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621030.html' target='_blank'>MedLinePlus: Dostarlimab</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/parp-inhibitors-cancer/' target='_blank'>Metastatic Trial Talk: PARP Inhibitors</a> </li></ul>
43

Niraparib and Dostarlimab for BRCA+ Advanced Breast Cancer

Phase IB Trial of Niraparib and TSR-042 in Patients With BRCA-Mutated Breast, Pancreas or Ovary Cancer
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Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
1 visit every 3 weeks for 3 months, then every 6 weeks, ongoing

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ClinicalTrials.gov: NCT04673448

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Phase I

44

Immunotherapy and BT8009 for Metastatic Breast Cancer that Expresses Nectin-4

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

Purpose: To study the safety, anti-cancer activity, and effects (good and bad) of giving the experimental therapy BT8009 alone or in combination with the <span class="highlight">PD-1</span> inhibitor nivolumab (Opdivo®).

Who is this for?: People with metastatic (stage IV) breast cancer that expresses Nectin-4 and who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009 is an experimental therapy that targets Nectin-4, a protein expressed in some breast cancer cells, and delivers a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nectin-4 is often expressed in triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called <span class="highlight">PD-1</span> (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Nectin-4</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04561362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-first-patient-dosed-phase-iii-0' target='_blank'>Press Release: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Drug Information Page: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Nectin' target='_blank'>Wikipedia: Nectin</a> </li></ul>
44

Immunotherapy and BT8009 for Metastatic Breast Cancer that Expresses Nectin-4

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
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Nearest Location:
948 miles
Sarah Cannon Research Institute at HealthONE
Denver, CO

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Visits:
1 visit a week, ongoing

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ClinicalTrials.gov: NCT04561362

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Phase I-II

45

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/Metastatic Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of two immunotherapy drugs, NM1F and pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer whose cancer has progressed on standard treatments. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM1F, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM1F is a type of immunotherapy called a PVRIG inhibitor that may work better when combined with pembrolizumab (Keytruda®). Blocking PVRIG may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05746897' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.pharmabiz.com/NewsDetails.aspx?aid=155259&sid=2' target='_blank'>Pharmabiz: NM1F</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab</a> </li></ul>
45

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/Metastatic Solid Tumors
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Nearest Location:
1471 miles
NEXT Oncology, Dallas
Dallas, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05746897

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Phase I

46

IMGS-001 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of IMGS-001, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), <span class="highlight">PD-L1</span> positive breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMGS-001, by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMGS-001 is an experimental immunotherapy that targets <span class="highlight">PD-L1</span> and PD-L2.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06014502' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunogenesis.com/science/' target='_blank'>ImmunoGenesis: What is IMGS-001?</a> </li></ul>
46

IMGS-001 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors
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Nearest Location:
1471 miles
NEXT Dallas
Irving, TX

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Visits:
1 visit every 2 weeks for 1 year

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ClinicalTrials.gov: NCT06014502

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Phase I

47

ABBV-151 and ABBV-181 for Advanced Triple Negative Breast Cancer

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

Purpose: To investigate the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has been treated with at least one systemic therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of the 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">ABBV-181, by IV, once a month, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. </li> <li class="seamTextUnorderedListItem">ABBV-181 is an experimental <span class="highlight">PD-1</span> inhibitor. This type of immunotherapy, called a checkpoint inhibitor, gets the immune system to see and go after cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03821935' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-151.html' target='_blank'>Drug company information page: ABBV-151</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/abbv-181/' target='_blank'>Immuno-oncology news: ABBV-181</a> </li></ul>
47

ABBV-151 and ABBV-181 for Advanced Triple Negative Breast Cancer

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors
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Nearest Location:
1481 miles
NEXT Oncology /ID# 208930
San Antonio, TX

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Visits:
1 visit every month, ongoing

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ClinicalTrials.gov: NCT03821935

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Phase I

48

BDC-3042 Targeted Therapy for Metastatic Triple Negative Breast Cancer

A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-3042 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BDC-3042, an experimental dectin-2 inhibitor, alone and with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042 is an experimental targeted therapy called a dectin-2 inhibitor. Blocking dectin-2 stimulates the immune system's ability to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06052852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.boltbio.com/pipeline-new/#bdc-3042' target='_blank'>Bolt Biotherapeutics: BDC-3042 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pennmedicine.org/news/news-releases/2019/january/energizing-the-immune-system-to-eat-cancer' target='_blank'>University of Pennsylvania: Awakening Immune Cells Called Macrophages to Kill Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
48

BDC-3042 Targeted Therapy for Metastatic Triple Negative Breast Cancer

A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-3042 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies
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Nearest Location:
1481 miles
NEXT Oncology
San Antonio, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06052852

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Phase I-II

49

Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or ER Low Breast Cancer

Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer

Purpose: To study the anti-cancer activity, safety, and side effects of first giving bortezomib (Velcade®), then giving pembrolizumab (Keytruda®) and cisplatin (Platinol®).

Who is this for?: Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who have not received more than three chemotherapies for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®), by IV</li> <li class="seamTextUnorderedListItem">followed by, pembrolizumab (Keytruda®) and cisplatin (Platinol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®) is a type of targeted therapy called a protease inhibitor. It is approved for use in some other cancers but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. It gets the immune system to go after cancer cells. It is approved for use in some cancers but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy commonly used for metastatic triple negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04265872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Bortezomib' target='_blank'>Wikipedia: Bortezomib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.velcade.com/about-velcade/faq' target='_blank'>Takeda Pharmaceutical Company Drug Information Page: Velcade® (Bortezomib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/86804' target='_blank'>MedPage Today: Pembrolizumab May Help in Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncobites.blog/2020/02/07/cisplatin-a-journey-to-a-solution-for-triple-negative-breast-cancer/' target='_blank'>OncoBites Blog: Cisplatin--A Journey to a Solution for Triple-Negative Breast Cancer</a> </li></ul>
49

Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or ER Low Breast Cancer

Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer
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Nearest Location:
1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, TX

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Visits:
Number of visits unavailable, ongoing

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ClinicalTrials.gov: NCT04265872

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Phase NA

50

PLN-101095 Immunotherapy with Pembrolizumab for Advanced Breast Cancer

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembro...

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of PLN-101095, an experimental immunotherapy, with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. You must have received pembrolizumab (Keytruda®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PLN-101095</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PLN-101095 is an experimental immunotherapy. PLN-101095 may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06270706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://pliantrx.com/oncology/' target='_blank'>Pliant Therapeutics: PLN-101095 Drug Information Page</a> </li></ul>
50

PLN-101095 Immunotherapy with Pembrolizumab for Advanced Breast Cancer

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembro...
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Nearest Location:
1498 miles
NEXT Austin
Austin, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06270706

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Phase I

51

Bria-IMT Cell Therapy for Advanced Breast Cancer

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of the Bria-IMT regimen, an experimental cell therapy, alone and with retifanlimab (Zynyz®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Bria-IMT Regimen with Immunotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 day every 3 weeks</li> <li class="seamTextUnorderedListItem">SV-BR-1-GM, by injection, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Interferon, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®), by infusion, every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Bria-IMT Regimen Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 day every 3 weeks</li> <li class="seamTextUnorderedListItem">SV-BR-1-GM, by injection, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Interferon, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Bria-IMT regimen is an experimental cell therapy with SV-BR-1-GM cells.</li> <li class="seamTextUnorderedListItem">Before you receive the cell therapy, you will receive cyclophosphamide (Cytoxan®) chemotherapy to prepare your body to receive the cells.</li> <li class="seamTextUnorderedListItem">Interferon is an immunotherapy used to regulate your immune response to the cell therapy.</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06072612' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://briacell.com/briaimt/' target='_blank'>BriaCell Therapeutics: Bria-IMT Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/retifanlimab-dlwr' target='_blank'>National Cancer Institute: Retifanlimab (Zynyz®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
51

Bria-IMT Cell Therapy for Advanced Breast Cancer

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.
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Nearest Location:
1500 miles
AMR Kansas City Oncology
Kansas City, KS

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT06072612

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Phase III

52

ONM-501 Targeted Therapy for Advanced Breast Cancer

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ONM-501, an experimental STING inhibitor, alone and with cemiplimab (Libtayo®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501, by injection, 3 times every 1.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501, by injection, 3 times every 1.5 months</li> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501 is an experimental targeted therapy called a STING inhibitor. Blocking STING may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06022029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://onconano.com/our-technology/' target='_blank'>OncoNano Medicine: ONM-501 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618054.html' target='_blank'>Medline Plus: Cemiplimab (Libtayo®)</a> </li></ul>
52

ONM-501 Targeted Therapy for Advanced Breast Cancer

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas
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Nearest Location:
1509 miles
University of Texas Southwestern Medical Center
Dallas, TX

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Visits:
3 visits every 1.5 months

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ClinicalTrials.gov: NCT06022029

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Phase I

53

Niraparib and Dostarlimab for Metastatic Triple-Negative or BRCA1/2 Mutant Breast Cancer that has Spread to the Brain

Phase II Trial of the PARP Inhibitor Niraparib and <span class="highlight">PD-1</span> Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of the combination of niraparib (Zejula®), a PARP inhibitor, and dostarlimab (Jemperli®), an immunotherapy, to control breast cancer that has spread to the brain.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or BRCA1/2 mutated breast cancer that has spread to the brain (brain metastasis). You must have received at least one standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05700721' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
53

Niraparib and Dostarlimab for Metastatic Triple-Negative or BRCA1/2 Mutant Breast Cancer that has Spread to the Brain

Phase II Trial of the PARP Inhibitor Niraparib and <span class="highlight">PD-1</span> Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05700721

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Phase II

54

Keytruda plus Bacterial Therapy for Advanced Breast (and Other) Tumors

A Phase Ib Investigation of Pembrolizumab in Combination With Intratumoral Injection of Clostridium Novyi-NT in Patients With Treatment-Refractory Solid Tumors

Purpose: To study the safety, effects (good and bad) and best dose of a type of bacteria that researchers believe will prime tumors to respond to an immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bacterial therapy (Clostridium Novyi-NT), by injection, once, on Day 8, during 1-week hospital stay</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for up to 1 year</li> <li class="seamTextUnorderedListItem">Doxocyclin, by mouth, 2 times a day for the rest of your life to lower the risk of further growth of Clostridium novyi-NT</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The bacteria have been modified to remove the chemicals that are poisonous to humans. </li> <li class="seamTextUnorderedListItem">The bacterial therapy being used in this study is clostridium novyi-NT. </li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the <span class="highlight">PD-1</span> inhibitor pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda stimulates the body's immune system to go after cancer cells. It is approved to treat select types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">You will also receive the antibiotic, doxocyclin. It is given to help keep the growth of the bacteria clostridium novyi-NT under control.</li> <li class="seamTextUnorderedListItem">Your body is home to many bacteria, viruses, and fungi, which are collectively called the microbiome.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03435952' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/clostridium-novyi-nt-spores' target='_blank'>NCI Drug Dictionary: Clostridium novyi-NT</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedirect.com/science/article/pii/S2352304216000064' target='_blank'>ScienceDirect: Clostridium novyi-NT in Cancer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li></ul>
54

Keytruda plus Bacterial Therapy for Advanced Breast (and Other) Tumors

A Phase Ib Investigation of Pembrolizumab in Combination With Intratumoral Injection of Clostridium Novyi-NT in Patients With Treatment-Refractory Solid Tumors
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Nearest Location:
1643 miles
University of Texas MD Anderson Cancer Center
Houston, TX

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Visits:
Hospital stay for 1 week; 4 visits in the first month; then 1 visit every 3 weeks for up to 1 year

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ClinicalTrials.gov: NCT03435952

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Phase I

55

Pembrolizumab and Lenvatinib for People with Breast Cancer Brain Metastases

Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor and pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05064280' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li></ul>
55

Pembrolizumab and Lenvatinib for People with Breast Cancer Brain Metastases

Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05064280

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Phase II

56

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy with ribociclib (Kisqali®) or palbociclib (Ibrance®) CDK4/6 inhibitors.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER2 enriched or Basal like breast cancer. You must not have received treatment with chemotherapy for advanced disease or any CDK4/6 inhibitors. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HER2 Enriched Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 Enriched Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Basal Like Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) with or without tislelizumab</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and palbociclib (Ibrance®) are types of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tislelizumab is an experimental immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">The PAM50 (Prosigna®) test will determine if you have HER2 enriched or Basal like breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05207709' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/our-science-and-medicines/tislelizumab/' target='_blank'>Beigene: Tislelizumab Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/diagnosis/molecular-subtypes/' target='_blank'>Susan G. Komen: HER2-Enriched and Basal-Like Breast Cancer</a> </li></ul>
56

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial
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Nearest Location:
1835 miles
Carle Cancer Center
Urbana, IL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05207709

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Phase III

57

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)

Purpose: To determine the safety and effects (good and bad) of treating HER2-negative metastatic breast cancer with an immunotherapy drug along with a chemotherapy drug.

Who is this for?: People with metastatic (stage IV) breast cancer that is HER2 negative. If you are estrogen receptor positive, you must have progressed on available endocrine therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for up to 2 years</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is a <span class="highlight">PD-1</span> inhibitor. </li> <li class="seamTextUnorderedListItem">The chemotherapy drug is carboplatin (Paraplatin®). It is used to treat metastatic breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03213041' target='_blank'>ClinicalTrials.gov</a> </li></ul>
57

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)
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Nearest Location:
1856 miles
Northwestern University
Chicago, IL

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Visits:
1 visit every 3 weeks, ongoing

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ClinicalTrials.gov: NCT03213041

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Phase II

58

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in <span class="highlight">PD-L1-negative</span> Metastatic Triple Negative Breast Cancer (TNBC)

Purpose: To study the safety and anti-cancer activity of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy) alone and in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-. HER2-) or ER Low (1%-10% ER), HER2 negative breast cancer that is <span class="highlight">PD-L1</span> negative, who have not yet started treatment for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low. This trial is enrolling people with triple negative as well as ER Low, HER2 negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04468061' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/dosing' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/pembrolizumab' target='_blank'>Cancer Research UK: Pembrolizumab (Keytruda)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>NIH MedlinePlus: PDL1 (Immunotherapy) Tests</a> </li></ul>
58

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in <span class="highlight">PD-L1-negative</span> Metastatic Triple Negative Breast Cancer (TNBC)
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Nearest Location:
1857 miles
University of Chicago Medical Center
Chicago, IL

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Visits:
2 visits every 3 weeks

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ClinicalTrials.gov: NCT04468061

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Phase II

59

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, <span class="highlight">PD-L1</span> Negative Breast Cancer

A Phase II Trial of Carboplatin +/- Tocilizumab as Initial Therapy for Metastatic Triple Negative and ER-low Breast Cancers

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of carboplatin (Paraplatin®) chemotherapy alone or with tocilizumab, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR-, HER2- or HER2 low), <span class="highlight">PD-L1</span> negative breast cancer who have not received chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tocilizumab, by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tocilizumab is an experimental immunotherapy called an IL-6 inhibitor that is approved to treat arthritis. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ and FISH-.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05846789' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a611004.html' target='_blank'>MedlinePlus: Tocilizumab</a> </li></ul>
59

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, <span class="highlight">PD-L1</span> Negative Breast Cancer

A Phase II Trial of Carboplatin +/- Tocilizumab as Initial Therapy for Metastatic Triple Negative and ER-low Breast Cancers
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Nearest Location:
1944 miles
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, IN

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Visits:
1-2 visits every month

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ClinicalTrials.gov: NCT05846789

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Phase II

60

KFA115 Immunotherapy Alone and With Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of KFA115, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115 is an experimental immunotherapy.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05544929' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/research-development/novartis-pipeline?search_api_fulltext=KFA115' target='_blank'>Novartis Pharmaceuticals: KFA115 Drug Information Page</a> </li></ul>
60

KFA115 Immunotherapy Alone and With Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
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Nearest Location:
1959 miles
SCRI Oncology Partners Sarah Cannon new location
Nashville, TN

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT05544929

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Phase I

61

Palliative Radiation and Immunotherapy for Metastatic Breast Cancer

A Phase 2 Study of Palliative Radiation in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiation with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?: Women with stage IV (metastatic) breast cancer who have received at least 2 lines of therapy, including 1 line of chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, 1-5 sessions</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Palliative radiation reduces side effects of metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04990921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncolink.org/support/hospice-and-palliative-care/palliative-radiation-treatment#:~:text=Palliative%20radiation%20is%20the%20use,doses)%20than%20traditional%20radiation%20treatment.' target='_blank'>OncoLink: Palliative Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
61

Palliative Radiation and Immunotherapy for Metastatic Breast Cancer

A Phase 2 Study of Palliative Radiation in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink
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Nearest Location:
1984 miles
James Graham Brown Cancer Center
Louisville, KY

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT04990921

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Phase II

62

How the Gut Microbiome May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Purpose: To study the gut microbiome to see if it can determine if immunotherapy will be effective.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) triple negative breast cancer (ER-, PR- and HER2-) who are about to begin treatment with a checkpoint inhibitor (immunotherapy). You must speak English or Spanish. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 blood tests over 6-8 weeks</li> <li class="seamTextUnorderedListItem">2 stool samples over 6-8 weeks</li> <li class="seamTextUnorderedListItem">Questionairres (in English or Spanish)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The microbiome may help determine if immunotherapy will be effective. </li> <li class="seamTextUnorderedListItem">By studying the microbiome, researchers may also be able to determine if changing the microbiome through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, can help the immune system fight cancer.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) are a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05037825' target='_blank'>ClinicalTrials.gov</a> </li></ul>
62

How the Gut Microbiome May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
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Nearest Location:
1985 miles
Baptist Health Clinical Research
Elizabethtown, KY

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Visits:
At least 2 visits over 6-8 weeks

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ClinicalTrials.gov: NCT05037825

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Phase NA

63

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor, stereotactic radiosurgery, chemotherapy, and durvalumab (Imfinzi®) <span class="highlight">PD-L1</span> inhibitor.

Who is this for?: Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) BRCA mutation. You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a <span class="highlight">PD-L1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-L1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711824' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>
63

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases
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Nearest Location:
2013 miles
University of Alabama at Birmingham
Birmingham, AL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04711824

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Phase I-II

64

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor, gemcitabine (Gemzar®) and carboplatin (Paraplatin®) chemotherapy, and trilaciclib (Cosela®) CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer. You must not have received more than 3 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) also helps protect the bone marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06027268' target='_blank'>ClinicalTrials.gov</a> </li></ul>
64

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)
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Nearest Location:
2299 miles
Levine Cancer Institute
Charlotte, NC

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06027268

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Phase II

65

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of chemokine modulation (CKM) therapy with pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose cancer progressed on prior treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rintatolimod (Ampligen®), by IV, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®), by mouth, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Interferon alpha 2b (Bioferon®), by IV, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, 2 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemokine modulation (CKM) therapy is a type of immunotherapy that involves rintatolimod (Ampligen®), celecoxib (Celebrex®), and interferon alpha 2b (Bioferon®).</li> <li class="seamTextUnorderedListItem">Rintatolimod (Ampligen®) is a drug for chronic fatigue syndrome that may also stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®) is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels that tumors need to grow and spread.</li> <li class="seamTextUnorderedListItem">Interferon alpha 2b (Bioferon®) helps the immune system fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">CKM therapy may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05756166' target='_blank'>ClinicalTrials.gov</a> </li></ul>
65

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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Visits:
6 visits within 2 weeks, then 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05756166

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Phase I-II

66

Dendritic Cell Vaccine and Pembrolizumab for Metastatic Triple Negative and HER2+ Breast Cancer With Brain Metastasis

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental type of immunotherapy, with pembrolizumab (Keytruda®), a type of immunotherapy.

Who is this for?: Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis) and progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for 3 sessions (potential additional sessions every 3 months)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 brain MRI</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the brain is called brain metastasis.</li> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an experimental type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04348747' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org: About Breast Cancer Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancer.org: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy' target='_blank'>Roswell Park Comprehensive Cancer Center Press Release: Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer</a> </li></ul>
66

Dendritic Cell Vaccine and Pembrolizumab for Metastatic Triple Negative and HER2+ Breast Cancer With Brain Metastasis

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)
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Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT04348747

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Phase II

67

Atezolizumab With Tivozanib for Metastatic Hormone Negative, HER2 Positive Breast Cancer

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Purpose: To study the effects (good and bad) and anti-cancer activity of atezolizumab (Tecentriq®) immunotherapy given together with tivozanib (Fotivda®) immunotherapy.

Who is this for?: People with metastatic (stage IV) hormone negative (ER-/PR-), HER2 positive (HER2+) breast cancer who have received at least three lines of therapy and have not received treatment with immunotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 4 weeks</li> <li class="seamTextUnorderedListItem">Tivozanib (Fotivda®), by mouth, daily, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a <span class="highlight">PD-L1</span> inhibitor. Blocking <span class="highlight">PD-L1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Tivozanib (Fotivda®) is a type of immunotherapy called a VEGFR inhibitor. Blocking VEGFR may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">You must not have received treatment with immunotherapy: pembrolizumab (Keytruda®), atezolizumab (Tecentriq®), or ipilimumab (Yervoy®).</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05000294' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com/' target='_blank'>Genentech Drug Information Page: Atezolizumab (Tecentriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fotivda.com/' target='_blank'>Aveo Oncology Drug Information Page: Tivozanib (Fotivda®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://investor.aveooncology.com/news-releases/news-release-details/aveo-oncology-presents-three-posters-tivozanibimmunotherapy' target='_blank'>Aveo Oncology Press Release: Atezolizumab (Tecentriq®) with ivozanib (Fotivda®)</a> </li></ul>
67

Atezolizumab With Tivozanib for Metastatic Hormone Negative, HER2 Positive Breast Cancer

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
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Nearest Location:
2351 miles
University of Florida
Gainesville, FL

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT05000294

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Phase I-II

68

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer

Purpose: To investigate the safety and effects (good and bad) of combining the <span class="highlight">PD-1</span> inhibitor Keytruda with an immunotherapy made from your T-cells.

Who is this for?: Women with metastatic (stage IV) breast cancer. You must have had two or more prior therapies (chemotherapy or hormonal) for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once during week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice, during week 3-4 and week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, three times, before BATs, during week 3-4 and week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. May require hospitalization</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. </li> <li class="seamTextUnorderedListItem">HER2 bispecific antibody armed T cells (BATs) are an experimental type of T-cell immunotherapy. </li> <li class="seamTextUnorderedListItem">The HER2 BATs will be made by collecting white blood cells from your body. Your white blood cells will then be modified in a lab so they can identify and attack cancer cells. These modified cells will then be infused back into your body.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03272334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2bi-armed-activated-t-cells' target='_blank'>NCI Drug Dictionary: HER2Bi-armed ATCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4839366/' target='_blank'>OncoImmunology: HER2 BATs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwt-L2BRA_EiwAacX32ZWZ-hf-RSddVt1Y8_oFJEJzejiyhC9eCFhl1JG4WlqWBf2Aq3rrXhoCf7AQA' target='_blank'>Merck Oncology Drug Information Page: Keytruda®</a> </li></ul>
68

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer
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Nearest Location:
2376 miles
Ashley Donihee
Charlottesville, VA

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Visits:
1-2 visits a week for 7 weeks, may require hospitalization

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ClinicalTrials.gov: NCT03272334

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Phase I-II

69

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

A Phase I Pilot Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a personalized neoantigen peptide vaccine, an experimental type of immunotherapy, with pembrolizumab (Keytruda®), a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that have received at least 1 line of standard treatment. If you have triple negative (ER-, PR-, HER2-) breast cancer, you must currently be receiving treatment with pembrolizumab (Keytruda®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 session</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, 4 times in 2 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Sargramostim, by injection, 4 times in 2 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require at least 1 biopsy</li> <li class="seamTextUnorderedListItem">May require 1 additional vaccine</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The neoantigen peptide vaccine will be personalized to your cancer based on your blood and biopsy results.</li> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy.</li> <li class="seamTextUnorderedListItem">The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Before you receive the vaccine, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the vaccine.</li> <li class="seamTextUnorderedListItem">Sargramostim is a type of immunotherapy that stimulates your body to produce more immune cells to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05269381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20529594?_ga=2.9537585.506318734.1653082699-1752475516.1651774270' target='_blank'>Mayo Clinic: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20884-sargramostim-gm-csf-injection' target='_blank'>Cleveland Clinic: Sargramostim</a> </li></ul>
69

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

A Phase I Pilot Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)
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Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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Visits:
5 visits in 3 weeks, then 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05269381

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Phase I

70

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Phase I Study of MEM-288 Oncolytic Virus in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MEM-288, an experimental vaccine.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has progressed after treatment with chemotherapy and at least 1 <span class="highlight">PD-1/PD-L1</span> inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 vaccine, by injection, every 3 weeks, 2-6 sessions over 2-4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires at least 1 biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 is a vaccine that contains an oncolytic virus, a type of virus that targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">MEM-288 is injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05076760' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.memgenbio.com/' target='_blank'>Memgen Drug Information Page: MEM-288</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dukehealth.org/clinical-trials/directory/pro00109517' target='_blank'>Duke Health Clinical Trial Information Page: MEM-288</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/?utm_source=google&utm_medium=cpc&gclid=CjwKCAjwy_aUBhACEiwA2IHHQEa-vmAWsJZO8726oOg7bjIG8ru8smOjq4_rDRC9cRbLdE3XRu6cVRoCwCEQAvD_BwE' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/en-us/immunotherapy/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute: Oncolytic Viruses</a> </li></ul>
70

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Phase I Study of MEM-288 Oncolytic Virus in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)
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Nearest Location:
2385 miles
Duke Cancer Institute
Durham, NC

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Visits:
1 visit every 3 weeks for 2-4 months

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ClinicalTrials.gov: NCT05076760

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Phase I

71

MEDI4736 with Lynparza or Cediranib for Advanced Triple Negative Breast Cancer

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer

Purpose: To study the safety and effects (good and bad) of giving MEDI4736 and Lynparza together.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer for whom no currently available treatment exists. You must not have received more than three prior therapies for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> Participants will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (MEDI4736) is an immunotherapy drug that works by blocking a protein called <span class="highlight">PD-L1</span> (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. </li> <li class="seamTextUnorderedListItem">Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02484404' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=740856' target='_blank'>NCI Drug Dictonary: MEDI4736</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=560191' target='_blank'>NCI Drug Dictonary: Olaparib</a> </li></ul>
71

MEDI4736 with Lynparza or Cediranib for Advanced Triple Negative Breast Cancer

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Every 2 weeks for 1 year

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ClinicalTrials.gov: NCT02484404

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Phase I-II

72

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, <span class="highlight">PD-L1</span> Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

Purpose: To study the safety and anti-cancer activity of giving radiation therapy with a PARP inhibitor and a <span class="highlight">PD-1</span> inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. You must not have received more than two systemic therapies for advanced disease and you must not have a BRCA 1/2 mutation (inherited or tumor). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV, every 3 weeks for 3 months, then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Radiation therapy, 3 times, during the first week of treatment</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low. This trial is enrolling people with triple-negative as well as ER Low breast cancer. </li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®)is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is considered an experimental drug in this trial. </li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is an experimental <span class="highlight">PD-1</span> inhibitor. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the <span class="highlight">PD-1</span> protein.</li> <li class="seamTextUnorderedListItem">An experimental therapy is a drug approved by the FDA for studying in people in clinical trials. A drug may be FDA approved for use in one disease but still considered experimental for use in breast cancer. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Researchers believe that radiation therapy may also boost the immune system, which will help the immune system go after and kill cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04837209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/triple-negative-breast-cancer-treatment-symptoms-research' target='_blank'>BCRF: Triple-Negative Breast Cancer: Symptoms, Treatment, Research</a> </li></ul>
72

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, <span class="highlight">PD-L1</span> Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)
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Nearest Location:
2433 miles
Sibley Memorial Hospital
Washington, DC

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Visits:
3 visits for the first week, then every 3 weeks for 3 months, then every 6 weeks, ongoing

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ClinicalTrials.gov: NCT04837209

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Phase II

73

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor, and fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a <span class="highlight">PD-1/PD-L1</span> inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
73

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT06110793

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Phase I-II

74

Pembrolizumab and Cryoablation for Advanced Triple Negative Breast Cancer

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) <span class="highlight">PD-1</span> inhibitor with cryoablation, an experimental alternative to surgery.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received 1-2 lines of therapy and are planning to receive pembrolizumab (Keytruda®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Cryoablation</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor, which is a type of immune checkpoint inhibitor. Blocking <span class="highlight">PD-1</span> may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Cryoablation is a procedure in which an extremely cold liquid or device is used to freeze and destroy cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06246968' target='_blank'>ClinicalTrials.gov</a> </li></ul>
74

Pembrolizumab and Cryoablation for Advanced Triple Negative Breast Cancer

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
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Nearest Location:
2539 miles
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT06246968

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Phase I

75

Radiation Therapy, Immunotherapy, and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses

Purpose: To study the safety and anti-cancer activity of using radiation therapy and the immunotherapy pembrolizumab (Keytruda®) with or without the PARP inhibitor olaparib (Lynparza®).

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a PARP inhibitor or more than two systemic therapies for advanced disease. To enroll, you must not have a BRCA 1/2 mutation (inherited or tumor). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, for 6 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor or <span class="highlight">PD-1</span> inhibitor. It helps the immune system to go after cancer cells by blocking the <span class="highlight">PD-1</span> protein.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved to treat some advanced triple-negative breast cancer, but its use in this trial, however, is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a PARP inhibitor. It works by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation. Its use in this trial, however, is considered experimental. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04683679' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/does-immunotherapy-treat-breast-cancer.h00-159385101.html' target='_blank'>MD Anderson Cancer Center: Does Immunotherapy Treat Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-approves-keytruda-for-pd-l1-pos-tnbc' target='_blank'>Breastcancer.org: FDA Approves Immunotherapy Keytruda for PD-L1-Positive Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li></ul>
75

Radiation Therapy, Immunotherapy, and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
8 visits over 2 months

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ClinicalTrials.gov: NCT04683679

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Phase II

76

Keytruda for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability

Purpose: To study the effects (good and bad) of using an immunotherapy drug to treat cancer that has spread outside the breast to nearby tissue or lymph nodes or to other parts of the body.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been tested for and found to have a BRCA 1 or BRCA 2 tumor mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a <span class="highlight">PD-1</span> inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death <span class="highlight">(PD-1).</span> </li> <li class="seamTextUnorderedListItem">Keytruda® is currently approved to treat certain types of cancers.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03428802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/parp-inhibitor-may-prolong-survival-in-metastatic-brcapositive-breast-cancer' target='_blank'>Cure Today: Parp Inhibitor May Prolong Survival</a> </li></ul>
76

Keytruda for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability
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Nearest Location:
2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT03428802

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Phase II

77

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer

Purpose: To study the safety and anti-cancer activity of combining the experimental checkpoint inhibitor MGA012 with the oncolytic virus pelareorep.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received one to three prior therapies for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pelareorep, by IV, 2 days a week, every other week, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, once a month, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein <span class="highlight">PD-1.</li></span> <li class="seamTextUnorderedListItem">Pelareorep is an oncolytic virus--a virus that targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04445844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>Macrogenics Drug Information Page: Retifanlimab (MGA012)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Pelareorep' target='_blank'>Wikipedia: Pelareorep</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancer-news.com/2020/09/14/first-patient-dosed-irene-clinical-trial-testing-immunotherapy-oncolytic-virus-combo-for-tnbc/' target='_blank'>Breast Cancer News: First Patient Dosed in IRENE Trial Testing Immunotherapy-Oncolytic Virus Combo</a> </li><li class='seamTextUnorderedListItem'><a href='https://graspcancer.org/wp-content/uploads/2021/12/Group6E_2.pdf' target='_blank'>GRASP: IRENE Study research poster</a> </li></ul>
77

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer
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Nearest Location:
2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

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Visits:
5 visits per month, ongoing

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ClinicalTrials.gov: NCT04445844

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Phase II

78

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Purpose: To study the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with stereotactic radiosurgery (SRS) to treat breast cancer that has spread to the brain.

Who is this for?: Women with metastatic (stage IV) breast cancer and at least two brain metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once after the first treatment of pembrolizumab</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor.</li> <li class="seamTextUnorderedListItem">It stimulates the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is not surgery. It is a type of radiation therapy that precisely targets metastases in the brain.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03449238' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain/radiosurgery' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery for Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li></ul>
78

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
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Nearest Location:
2567 miles
Weill Cornell Medicine
New York, NY

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Visits:
1 visit every 3 weeks, ongoing

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ClinicalTrials.gov: NCT03449238

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Phase I-II

79

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma

Purpose: To test the safety and effects (good and bad) of an experimental immunotherapy injected into metastases when combined with radiation and pembrolizumab (Keytruda®).

Who is this for?: People with metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Flt3L(CDX-301), by injection</li> <li class="seamTextUnorderedListItem">Radiation, 2 small treatments, on day 1 and day 2</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol), by injection </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapies injected into the metastases are flt3L and poly-ICLC. </li> <li class="seamTextUnorderedListItem">Flt3L is an immune cell growth factor. It gets the body to make more immune cells. </li> <li class="seamTextUnorderedListItem">Poly-ICLC is an immune cell activating factor. It turns on the immune cells that have been brought to the tumor by flt3L. </li> <li class="seamTextUnorderedListItem">Radiation therapy will be targeted at the same metastases as these immunotherapies.</li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a <span class="highlight">PD-1</span> inhibitor that is given intravenously (IV). It stimulates the body's immune system to go after cancer cells. It is approved to treat more than 10 types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03789097' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celldex.com/pipeline/cdx-301.php' target='_blank'>Drug company information page: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/poly-iclc' target='_blank'>NCI Drug Dictionary: poly ICLC</a> </li></ul>
79

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma
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Nearest Location:
2569 miles
Icahn School of Medicine at Mount Sinai
New York, NY

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT03789097

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Phase I-II

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