MTS Trials - BreastCancerTrials.org

1

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

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A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of P-MUC1C-ALLO1, an experimental CAR-T cell 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?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, 1 session</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, multiple sessions</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) may be given for safety</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 is an experimental immunotherapy called CAR-T cell therapy.</li> <li class="seamTextUnorderedListItem">Allogeneic CAR-T cell therapy is an immunotherapy made from donor immune cells.</li> <li class="seamTextUnorderedListItem">Donor immune cells are modified with chimeric antigen receptors (CARs) so they can attack cancer cells.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) is an enzyme that can be administered for safety to kill CAR-T cells, if needed.</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/NCT05239143' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://poseida.com/science/pipeline/#cart-therapies' target='_blank'>Poseida Therapeutics Drug Information Page: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-p-muc1c-allo1-a-fully-allogeneic-car-t-targeting-multiple-solid-tumors-301447910.html' target='_blank'>Poseida Therapeutics Press Release: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bellicum.com/caspacide-safety-switch/' target='_blank'>Bellicum Phamaceuticals Drug Information Page: Rimiducid (CaspaCIDe®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2020.618427/full' target='_blank'>Journal Article: Allogeneic CAR T-Cell Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

1

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

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A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors

Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

Visits:
May require hospitalization

ClinicalTrials.gov: NCT05239143

Phase I

2

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

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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?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> </ul> Group 2 <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 PD-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/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>

2

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

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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)

Nearest Location:
3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05086692

Phase I-II

3

GSK4381562 Immunotherapy for Advanced Breast Cancer

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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 PD-1 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?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> </ul> Group 2 <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

3

GSK4381562 Immunotherapy for Advanced Breast Cancer

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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

Nearest Location:
3 miles
GSK Investigational Site
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05277051

Phase I

4

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

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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?

You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 2 <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> Group 3 <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 PD-L1 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>

4

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

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

Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

Visits:
1 visit every 2 weeks, ongoing

ClinicalTrials.gov: NCT03971409

Phase II

5

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

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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?

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

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 PD-L1 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>

5

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

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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

Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04143711

Phase I-II

6

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

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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®) PD-1 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?

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

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>

6

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

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

Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT03589339

Phase I

7

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

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A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors

Purpose: To study the safety, anti-cancer activity and side effects of giving an experimental immunotherapy made from cells from your own immune system.

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?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make the immunotherapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">CRX100, by IV</li> </ul> A hospital stay may be required

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CRX100 is the name of the immunotherapy used in this trial. It may work by directly killing cancer cells and by getting the immune system to go after and kill 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/NCT04282044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bioeclipse.com/clinical-trials-overview/' target='_blank'>BioEclipse Therapeutics Drug Information Page: CRX1000</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/25381063/' target='_blank'>Journal Article Abstract: Cytokine-Induced Killer (CIK) Cells in Cancer Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li></ul>

7

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

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A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors

Nearest Location:
27 miles
Stanford University
Stanford, CA

Visits:
May require hospital stay

ClinicalTrials.gov: NCT04282044

Phase I

8

E-602 Immunotherapy for Advanced Breast Cancer

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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?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> </ul> Group 2 <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

8

E-602 Immunotherapy for Advanced Breast Cancer

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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)

Nearest Location:
27 miles
Stanford Health Care
Stanford, CA

Visits:
1 visit every week

ClinicalTrials.gov: NCT05259696

Phase I-II

9

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

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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®) PD-L1 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?

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

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

9

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

Show Scientific Title

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

Nearest Location:
28 miles
Stanford Cancer Institute
Palo Alto, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05082610

Phase I

10

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced PD-L1 Positive, Triple Negative Breast Cancer

Show Scientific Title

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 PD-L1 (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 PD-1 inhibitor, compared to chemotherapy with pembrolizumab (Keytruda®).

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

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: ADC with Immunotherapy <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> Group 2: Chemotherapy with Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) with carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> with: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Additional Procedures <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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: PD-L1</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/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>

10

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced PD-L1 Positive, Triple Negative Breast Cancer

Show Scientific Title

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 PD-L1 (ASCENT-04)

Nearest Location:
53 miles
St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare
Santa Rosa, CA

Visits:
1 visit every 2-3 weeks

ClinicalTrials.gov: NCT05382286

Phase III

11

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

Show Scientific Title

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 PD-L1 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 PD-L1 negative and who have not yet received any treatment for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Vaccine <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> followed by: <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> Group 2: No Vaccine <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> followed by: <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 PD-L1 (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>

11

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

Show Scientific Title

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

Nearest Location:
74 miles
University of California Davis Comprehensive Cancer Center
Sacramento, CA

Visits:
Number of visits varies, ongoing

ClinicalTrials.gov: NCT03606967

Phase II

12

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

Show Scientific Title

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®) PD-1 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?

You will receive the following: <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> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Biopsies, 2 times</li> </ul> Please contact research site for treatment schedule

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

12

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

Show Scientific Title

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

Nearest Location:
74 miles
University of California Davis Comprehensive Cancer Center
Sacramento, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05673200

Phase I

13

BMS-986340 Immunotherapy for Advanced Breast Cancer

Show Scientific Title

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®) PD-1 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 PD-1 inhibitor. View full eligibility criteria

What's involved?

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

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

13

BMS-986340 Immunotherapy for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
164 miles
Community Cancer Institute
Clovis, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04895709

Phase I-II

14

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

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®) PD-1 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?

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

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

14

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
336 miles
UCLA Hematology/Oncology
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05585034

Phase I

15

NGM831 with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

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?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> </ul> Group 2 <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 PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking ILT3 and PD-1 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>

15

NGM831 with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
339 miles
NGM Clinical Study Site
Los Angeles, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT05215574

Phase I

16

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

Show Scientific Title

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of LYL797, an experimental type of immunotherapy called CAR T-cell therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR1 positive breast cancer that has progressed on standard treatment. You must not have received T-cell therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 CAR T-cell therapy</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 1 biopsy</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 is an experimental type of immunotherapy called CAR T-cell/CAR-T therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack ROR1 positive cancer cells</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of ROR1 positive cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</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/NCT05274451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lyell.com/our-pipeline' target='_blank'>Lyell Immunopharma Drug Information Page: LYL797</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-adoptive-cell-therapy' target='_blank'>Breastcancer.org: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

16

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

Show Scientific Title

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies

Nearest Location:
339 miles
University of California, Los Angeles
Santa Monica, CA

Visits:
Hospital stay may be required

ClinicalTrials.gov: NCT05274451

Phase I

17

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

Show Scientific Title

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®) PD-1 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?

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

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

17

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

Show Scientific Title

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

Nearest Location:
339 miles
UCLA Hematology/Oncology
Santa Monica, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05887492

Phase I-II

18

KVA12123 Immunotherapy for Advanced Breast Cancer

Show Scientific Title

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?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123, by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 1.5 months</li> </ul> Additional Procedures <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 PD-1 inhibitor. Blocking PD-1 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>

18

KVA12123 Immunotherapy for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
339 miles
UCLA Health (Santa Monica Cancer Care)
Santa Monica, CA

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT05708950

Phase I-II

19

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

Show Scientific Title

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®) PD-1 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?

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

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

19

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
339 miles
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05888831

Phase I-II

20

GEN1047 for Stage III or Stage IV Breast Cancer

Show Scientific Title

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of GEN1047, an experimental immunotherapy.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) breast cancer who have progressed after or during at least one prior therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047, by IV</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047 is a bispecific antibody that helps T cells kill cancer cells.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</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/NCT05180474' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genmab.com/pipeline/' target='_blank'>Genmab: GEN1047</a> </li></ul>

20

GEN1047 for Stage III or Stage IV Breast Cancer

Show Scientific Title

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

Nearest Location:
339 miles
UCLA Department of Medicine Hematology Oncology
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05180474

Phase I-II

21

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

Show Scientific Title

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 PD-L1 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?

You will receive the following: <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>

21

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

Show Scientific Title

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 PD-L1 Negative TNBC

Nearest Location:
341 miles
Cedars-Sinai Medical Center
Los Angeles, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT05318469

Phase I-II

22

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

Show Scientific Title

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 PD-1 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?

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

22

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

Show Scientific Title

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

Nearest Location:
341 miles
Cedars Sinai Medical Center
Los Angeles, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT05941507

Phase I-II

23

Immunotherapy and Radiation Therapy for Metastatic HER2 Negative Breast Cancer

Show Scientific Title

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of CDX-301, CDX-1140, and Poly ICLC (Hiltonol®) immunotherapies with radiation therapy.

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

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every 3 weeks for 3 months</li> </ul> followed 3-4 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 1 day every 3 weeks for 3 months</li> </ul> followed 1 day later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-1140, by infusion and/or injection, 1 day every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®), by injection, 1 day every 3 weeks for 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301 is an experimental immunotherapy called a Flt3 agonist, which means it binds to Flt3 on immune cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CDX-1140 is an experimental immunotherapy called a CD40 agonist, which means it binds to CD40 on immune cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®) is an immunotherapy that stimulates immune cells to go after and kill cancer cells.</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">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/NCT04616248' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-flt3-ligand' target='_blank'>National Cancer Institute: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-cdx-1140' target='_blank'>National Cancer Institute: CDX-1140</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 (Hiltonol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com/science' target='_blank'>Oncovir: Poly ICLC (Hiltonol®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

23

Immunotherapy and Radiation Therapy for Metastatic HER2 Negative Breast Cancer

Show Scientific Title

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease

Nearest Location:
348 miles
USC/Norris Comprehensive Cancer Center
Los Angeles, CA

Visits:
7 visits every 3 weeks for 3 months

ClinicalTrials.gov: NCT04616248

Phase I

24

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

Show Scientific Title

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®) PD-1 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?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> </ul> Group 2 <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

24

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

Show Scientific Title

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)

Nearest Location:
348 miles
USC Norris Comprehensive Cancer Center
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04585750

Phase I-II

25

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

Show Scientific Title

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?

You will be randomly assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> Group 2 <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> Group 3 <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> Group 4 <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> Group 5 <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> Group 6 <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> Group 7 <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 PD-L1 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>

25

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

Show Scientific Title

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)

Nearest Location:
353 miles
City of Hope
Duarte, CA

Visits:
At least 1 visit every 3 weeks

ClinicalTrials.gov: NCT03424005

Phase I-II

26

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is PD-L1 Positive

Show Scientific Title

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-), PD-L1 positive breast cancer who have not received treatment with pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Group 3 <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> Group 4 <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 PD-1 inhibitor. Blocking PD-1 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>

26

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is PD-L1 Positive

Show Scientific Title

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)

Nearest Location:
353 miles
City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte, CA

Visits:
1-5 visits per month

ClinicalTrials.gov: NCT05007106

Phase II

27

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

Show Scientific Title

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 PD-1 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?

You will receive the following: <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 PD-1 inhibitor. Blocking PD-1 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>

27

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

Show Scientific Title

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

Nearest Location:
353 miles
City of Hope Comprehensive Cancer Center
Duarte, CA

Visits:
At least every 3 weeks

ClinicalTrials.gov: NCT05070247

Phase I-II

28

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Show Scientific Title

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 Specific for a Cleaved Form of MUC1 (MUC1*)

Purpose: To look at the safety, best dose and effects of an experimental CAR T-cell immunotherapy that targets cancer cells that test positive for MUC1*, a special type of the MUC1 protein.

Who is this for?: People with metastatic (stage IV) breast cancer that tests positive for MUC1 and who have already received at least one standard therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Chemotherapy to deplete your lymph cells</li> <li class="seamTextUnorderedListItem">huMNC2-CAR44 CAR T-cells, by IV</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T cell or CAR-T cell therapy is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack MUC1 on 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/NCT04020575' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/car-t-cell-therapy.html' target='_blank'>MD Anderson Cancer Center: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/research/car-t-cells' target='_blank'>NCI: Car T-Cells</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.minervabio.com/clinical-trial-humnc2-car44-in-mbc/' target='_blank'>Minerva Biotechnologies: Study Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

28

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Show Scientific Title

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 Specific for a Cleaved Form of MUC1 (MUC1*)

Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

Visits:
May require hospitalization

ClinicalTrials.gov: NCT04020575

Phase I

29

Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy

Show Scientific Title

AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of eftilagimod alpha, an experimental immunotherapy, with paclitaxel (Taxol®) chemotherapy.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer who are planning to receive chemotherapy. You must not have yet received chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eftilagimod alpha (efti), by injection, 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, 6 months (standard of care)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eftilagimod alpha (efti), by injection, 6-7 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for eftilagimod alpha (efti), by injection, 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, 6 months (standard of care)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for eftilagimod alpha (efti), by injection, 6-7 months</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eftilagimod alpha (efti) is an experimental immunotherapy that activates the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug used 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/NCT05747794' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immutep.com/pipeline/clinical-pipeline.html#imp' target='_blank'>Immutep Drug Information Page: Eftilagimod Alpha (Efti)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

29

Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy

Show Scientific Title

AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization

Nearest Location:
359 miles
The Oncology Institute
Whittier, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05747794

Phase II-III

30

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

Show Scientific Title

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, PD-L1-Positive, 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 PD-L1 positive. You must have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <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> Group 2: Standard of Care <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 PD-1 (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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

30

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

Show Scientific Title

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, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Nearest Location:
366 miles
Cancer Blood and Specialty Clinic
Los Alamitos, CA

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT05852691

Phase II

31

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

Show Scientific Title

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?

This trial is being conducted in two parts. You will participate in 1 of 2 parts depending on when you enroll: Part 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> </ul> Part 2 <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 PD-1 (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>

31

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

Show Scientific Title

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

Nearest Location:
374 miles
University of California - Irvine Medical Center
Orange, CA

Visits:
1 visit a week, ongoing

ClinicalTrials.gov: NCT04180371

Phase I-II

32

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

Show Scientific Title

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®) PD-1 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> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101</li> <li class="seamTextUnorderedListItem">IL-2</li> </ul> followed by: <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

32

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

Show Scientific Title

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)

Nearest Location:
374 miles
University of California Irvine
Irvine, CA

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

ClinicalTrials.gov: NCT05576077

Phase I

33

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

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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?

You will be randomly assigned to 1 of 4 groups: Group 1 <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> Group 2 <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> Group 3 <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> Group 4 <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 PD-L1 (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>

33

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

Show Scientific Title

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)

Nearest Location:
437 miles
Research Site
Eugene, OR

Visits:
Approximately 1 visit a week

ClinicalTrials.gov: NCT03742102

Phase I-II

34

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

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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?

You will receive the following: <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> Additional procedures: <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 PD-L1 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>

34

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

Show Scientific Title

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

Nearest Location:
533 miles
OHSU Knight Cancer Institute
Portland, OR

Visits:
Monthly visits for 1 year

ClinicalTrials.gov: NCT03801369

Phase II

35

BAY3375968 Immunotherapy with PD-1 Inhibitor for Advanced Triple Negative Breast Cancer

Show Scientific Title

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®) PD-1 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?

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

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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

35

BAY3375968 Immunotherapy with PD-1 Inhibitor for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
595 miles
South Texas Accelerated Research Therapeutics | START Rocky Mountain Region
West Valley City, UT

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

ClinicalTrials.gov: NCT05537740

Phase I

36

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

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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?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SNS-101, by IV, every 3 weeks</li> </ul> with or without: <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 PD-1. 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>

36

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
595 miles
START Mountain Region
West Valley City, UT

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05864144

Phase I-II

37

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

Show Scientific Title

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 PD-1 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?

You will be assigned to 1 of 2 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> </ul> Group 2 <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 PD-1 (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>

37

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

Show Scientific Title

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

Nearest Location:
948 miles
Sarah Cannon Research Institute at HealthONE
Denver, CO

Visits:
1 visit a week, ongoing

ClinicalTrials.gov: NCT04561362

Phase I-II

38

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

Show Scientific Title

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?

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

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 PD-1 inhibitor. Blocking PD-1 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>

38

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
1471 miles
NEXT Oncology, Dallas
Dallas, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05746897

Phase I

39

IMGS-001 Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

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-), PD-L1 positive breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <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 PD-L1 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>

39

IMGS-001 Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
1471 miles
NEXT Dallas
Irving, TX

Visits:
1 visit every 2 weeks for 1 year

ClinicalTrials.gov: NCT06014502

Phase I

40

NM32-2668 Trispecific Antibody for Advanced ROR Expressing Breast Cancer

Show Scientific Title

A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of NM32-2668, an experimental trispecific antibody.

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

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM32-2668</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM32-2668 is an experimental immunotherapy called a trispecific antibody.</li> <li class="seamTextUnorderedListItem">A trispecific antibody binds to 3 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">NM32-2668 is a bispecific antibody that targets ROR1, CD3, and HSA.</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/NCT06299163' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://numab.com/pipeline/' target='_blank'>Numab Therapeutics: NM32-2668 Drug Information Page</a> </li></ul>

40

NM32-2668 Trispecific Antibody for Advanced ROR Expressing Breast Cancer

Show Scientific Title

A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors

Nearest Location:
1478 miles
Mary Crowley Cancer Research
Dallas, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06299163

Phase I

41

2 Immunotherapies and Chemotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic Triple Negative Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of CDX-301 and CDX-1140, two experimental types of immunotherapy, with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and have received 0-2 lines of therapy for advanced disease. You must not have received treatment with Adriamycin® (doxorubicin) or Doxil® (doxorubicin) chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month, starting month 2</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month, starting month 2</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 2 biopsies</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301 and CDX-1140 are experimental types of immunotherapy that allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">CDX-301 increases immune cells and CDX-1140 activates immune cells that are needed to kickstart the immune response.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a type of chemotherapy drug. It trains immune cells to recognize the cancer for the immune system to attack it.</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/NCT05029999' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://celldex.com/pipeline/overview/' target='_blank'>Celldex Therapeutics Drug Information Page: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-cdx-1140' target='_blank'>National Cancer Institute: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.celldex.com/news-releases/news-release-details/celldex-therapeutics-cdx-301-safely-mobilizes-hematopoietic' target='_blank'>Celldex Therapeutics Press Release: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/doxil' target='_blank'>Breastcancer.org: Doxorubicin (Doxil®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

41

2 Immunotherapies and Chemotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic Triple Negative Breast Cancer

Nearest Location:
1479 miles
Texas Oncology, P.A.
Dallas, TX

Visits:
1-5 visits every month

ClinicalTrials.gov: NCT05029999

Phase I

42

BDC-3042 Targeted Therapy for Metastatic Triple Negative Breast Cancer

Show Scientific Title

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®) PD-1 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?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042, by IV</li> </ul> Group 2 <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

42

BDC-3042 Targeted Therapy for Metastatic Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
1481 miles
NEXT Oncology
San Antonio, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06052852

Phase I-II

43

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

Show Scientific Title

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?

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

43

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

Show Scientific Title

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

Nearest Location:
1481 miles
NEXT Oncology /ID# 208930
San Antonio, TX

Visits:
1 visit every month, ongoing

ClinicalTrials.gov: NCT03821935

Phase I

44

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

Show Scientific Title

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?

You will receive the following: <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> Please contact research site for treatment schedule.

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 PD-1 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>

44

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

Show Scientific Title

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

Nearest Location:
1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, TX

Visits:
Number of visits unavailable, ongoing

ClinicalTrials.gov: NCT04265872

Phase NA

45

PLN-101095 Immunotherapy with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

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®) PD-1 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?

You will receive the following: <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

45

PLN-101095 Immunotherapy with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

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...

Nearest Location:
1498 miles
NEXT Austin
Austin, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06270706

Phase I

46

Bria-IMT Cell Therapy for Advanced Breast Cancer

Show Scientific Title

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®) PD-1 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?

You will be randomly assigned to 1 of 3 groups: Group 1: Bria-IMT Regimen with Immunotherapy <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> Group 2: Bria-IMT Regimen Alone <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> Group 3: Chemotherapy <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

46

Bria-IMT Cell Therapy for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
1500 miles
AMR Kansas City Oncology
Kansas City, KS

Visits:
May require hospitalization

ClinicalTrials.gov: NCT06072612

Phase III

47

ONM-501 Targeted Therapy for Advanced Breast Cancer

Show Scientific Title

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®) PD-1 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?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501, by injection, 3 times every 1.5 months</li> </ul> Group 2 <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

47

ONM-501 Targeted Therapy for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
1509 miles
University of Texas Southwestern Medical Center
Dallas, TX

Visits:
3 visits every 1.5 months

ClinicalTrials.gov: NCT06022029

Phase I

48

A Vaccine Injected Directly Into a Tumor for Metastatic Breast Cancer

Show Scientific Title

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer

Purpose: To study the best dose, safety, and anti-cancer activity of an experimental vaccine that is injected directly into the tumor.

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

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MV-s-NAP vaccine, by injection directly into your tumor, every 3 weeks, 4 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MV-s-NAP is the name of the vaccine used in this trial. It is made from a modified measles virus.</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/NCT04521764' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/breast-cancer/metastatic-breast-cancer-vaccine-treatment' target='_blank'>WebMD: Vaccine Treatment for Metastatic Breast Cancer</a> </li></ul>

48

A Vaccine Injected Directly Into a Tumor for Metastatic Breast Cancer

Show Scientific Title

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer

Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

Visits:
1 visit every 3 weeks for 2.5 months

ClinicalTrials.gov: NCT04521764

Phase I

49

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

Show Scientific Title

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?

You will receive the following: <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 PD-1 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>

49

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

Show Scientific Title

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

Nearest Location:
1643 miles
University of Texas MD Anderson Cancer Center
Houston, TX

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

ClinicalTrials.gov: NCT03435952

Phase I

50

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

Show Scientific Title

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?

You will receive the following: <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 PD-1 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>

50

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

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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)

Nearest Location:
1856 miles
Northwestern University
Chicago, IL

Visits:
1 visit every 3 weeks, ongoing

ClinicalTrials.gov: NCT03213041

Phase II

51

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

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Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative 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 PD-L1 negative, who have not yet started treatment for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <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> Group 2 <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 PD-1 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>

51

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

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Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)

Nearest Location:
1857 miles
University of Chicago Medical Center
Chicago, IL

Visits:
2 visits every 3 weeks

ClinicalTrials.gov: NCT04468061

Phase II

52

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, PD-L1 Negative Breast Cancer

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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), PD-L1 negative breast cancer who have not received chemotherapy for advanced disease. View full eligibility criteria

What's involved?

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

52

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, PD-L1 Negative Breast Cancer

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

Nearest Location:
1944 miles
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, IN

Visits:
1-2 visits every month

ClinicalTrials.gov: NCT05846789

Phase II

53

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

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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®) PD-1 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?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Group 3 <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

53

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

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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

Nearest Location:
1959 miles
SCRI Oncology Partners Sarah Cannon new location
Nashville, TN

Visits:
1 visit every month

ClinicalTrials.gov: NCT05544929

Phase I

54

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

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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?

You will receive the following: <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 PD-1 inhibitor. Blocking PD-1 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>

54

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

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The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Nearest Location:
1985 miles
Baptist Health Clinical Research
Elizabethtown, KY

Visits:
At least 2 visits over 6-8 weeks

ClinicalTrials.gov: NCT05037825

Phase NA

55

Gemcitabine Chemotherapy and NK Cell Therapy for Metastatic HER2 Negative Breast Cancer

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Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of gemcitabine (Gemzar®) chemotherapy and NK cell therapy with or without naxitamab (Danyelza®) targeted therapy.

Who is this for?: People with stage IV (metastatic) HER2 negative (HER2-) breast cancer who have received at least 1 line of therapy for metastatic disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy drug that blocks cancer cells from making DNA which may kill cancer cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is a type of targeted therapy called a GD2 inhibitor. GD2 inhibitors help your immune system attack tumor cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is approved to treat people with other types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy is an experimental immunotherapy. NK cells are part of your natural immune system and can identify cancer cells and help your immune system kill cancer cells.</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/NCT06026657' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/gemzar' target='_blank'>Breastcancer.org: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621005.html#:~:text=Naxitamab%2Dgqgk%20injection%20is%20used,have%20responded%20to%20other%20treatments.' target='_blank'>Medline Plus: Naxitamab (Danyelza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/body/24898-natural-killer-cells' target='_blank'>Cleveland Clinic: NK Cell 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></ul>

55

Gemcitabine Chemotherapy and NK Cell Therapy for Metastatic HER2 Negative Breast Cancer

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Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs)

Nearest Location:
2108 miles
Ohio State University Comprehensive Cancer Center
Columbus, OH

Visits:
May require hospitalization; 4-7 visits every month

ClinicalTrials.gov: NCT06026657

Phase I-II

56

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

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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®) PD-1 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?

You will receive the following: <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

56

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

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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

Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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

ClinicalTrials.gov: NCT05756166

Phase I-II

57

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

Show Scientific Title

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®) PD-1 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?

You will receive the following: <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

57

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

Show Scientific Title

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

Nearest Location:
2299 miles
Levine Cancer Institute
Charlotte, NC

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT06027268

Phase II

58

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

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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 PD-1 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?

You will receive the following: Group 1 <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> Group 2 <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> Group 3 <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> Please contact research site for treatment schedule. May require hospitalization

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 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>

58

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

Show Scientific Title

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

Nearest Location:
2376 miles
Ashley Donihee
Charlottesville, VA

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

ClinicalTrials.gov: NCT03272334

Phase I-II

59

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

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 PD-1 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?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 session</li> </ul> followed by: <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> Additional Procedures <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 PD-1 inhibitor. Blocking PD-1 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>

59

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

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

Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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

ClinicalTrials.gov: NCT05269381

Phase I

60

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Show Scientific Title

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 PD-1/PD-L1 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 vaccine, by injection, every 3 weeks, 2-6 sessions over 2-4 months</li> </ul> Additional Procedures <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>

60

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
2385 miles
Duke Cancer Institute
Durham, NC

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

ClinicalTrials.gov: NCT05076760

Phase I

61

PRGN-3007 CAR T Cell Therapy for Advanced Triple Negative, ROR-1 Positive Breast Cancer

Show Scientific Title

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRGN-3007 CAR T-cells, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR-1 positive breast cancer. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR T-cells</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR-T or CAR T cells are an experimental personalized immunotherapy made from your white blood cells. The white blood cells are removed from your body and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. These white blood cells are then infused into your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study trains the immune system to attack cancer cells that test positive for the protein ROR-1.</li> <li class="seamTextUnorderedListItem">Before you receive PRGN-3007 T-cells, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the immunotherapy.</li> <li class="seamTextUnorderedListItem">Leukapheresis is a procedure to collect your white blood cells to make your personalized CAR T-cell therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR-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/NCT05694364' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://precigen.com/pipeline/' target='_blank'>Precigen: PRGN-3007 Information Page</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://metastatictrialtalk.org/research-news/adoptive-cell-therapies/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-Cell Therapy</a> </li></ul>

61

PRGN-3007 CAR T Cell Therapy for Advanced Triple Negative, ROR-1 Positive Breast Cancer

Show Scientific Title

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies

Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

Visits:
May require hospitalization

ClinicalTrials.gov: NCT05694364

Phase I

62

T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

Show Scientific Title

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental T cell therapy using a person's own modified white blood cells with an experimental vaccine.

Who is this for?: People with stage IV (metastatic) breast cancer with a KRAS mutation who have received at least 2 lines of therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 1-4 days</li> <li class="seamTextUnorderedListItem">T cells, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Vaccine, by injection, 3-4 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer cells produce substances (antigens) that are unique to each cancer and stimulate the body's immune responses.</li> <li class="seamTextUnorderedListItem">Taking disease-fighting white blood cells (T cells) from a person, changing those cells so they will target the specific proteins (antigens) from the cancer cells, and returning them to that person's blood is a form of gene therapy.</li> <li class="seamTextUnorderedListItem">A vaccine may help these modified white cells work better.</li> <li class="seamTextUnorderedListItem">Leukapheresis is when blood is removed from the body, white blood cells are separated, and the remaining blood is returned to the body.</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin is a drug that stimulates the growth and development of T 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/NCT06253520' 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></ul>

62

T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

Show Scientific Title

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Requires hospitalization for 3-4 weeks

ClinicalTrials.gov: NCT06253520

Phase I

63

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Show Scientific Title

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

Purpose: To study the safety and effects (good and bad) of an immunotherapy that uses personalized T cells.

Who is this for?: People with metastatic (stage IV) breast cancer for which standard treatments have not worked. View full eligibility criteria

What's involved?

You will be in the hospital and receive the following: Before hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells), 2-4 months before receiving treatment</li> </ul> Hospital stay for receiving treatment (2-3 weeks): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, once a day, for 2 days </li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara), by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Followed by Aldesleukin, by IV, once every 8 hours, for up to 4 days </li> <li class="seamTextUnorderedListItem">TCR-Transduced T-Cells, by IV</li> </ul> After hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic and antiviral, for at least 6 months</li> <li class="seamTextUnorderedListItem">Screening tests, every few months for the first year, every 6 months for the second year, then as determined</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. </li> <li class="seamTextUnorderedListItem">The cancer cells will be analyzed to learn about the genetic mutations they contain. </li> <li class="seamTextUnorderedListItem">In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">They will then be infused into your body. This will take place in the hospital where the research study is taking place. </li> <li class="seamTextUnorderedListItem">When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. </li> <li class="seamTextUnorderedListItem">Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of metastatic 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/NCT03412877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2014/ACTepithelial' target='_blank'>National Cancer Institute Press Release: Immunotherapy</a> </li></ul>

63

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Show Scientific Title

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Hospital stay for up to 9 days; screening test every few months for 2 years

ClinicalTrials.gov: NCT03412877

Phase II

64

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

Show Scientific Title

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers

Purpose: To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer that tests positive for CD70 who have already received at least one standard therapy. View full eligibility criteria

What's involved?

You will receive the following: Hospital stay (at least 1-week): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV, once a day, for 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine, by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 3 times a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 CAR T-cells, by IV, one time</li> </ul> Post-hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic for 6 months</li> <li class="seamTextUnorderedListItem">Repeat Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab tests, imaging studies, and a physical exam), every 1-3 months for the 1st year after treatment, every 6 months for the 2nd year, and then as determined by your doctor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">After your blood cells are removed, they are modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. </li> <li class="seamTextUnorderedListItem">Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD70</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/NCT02830724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr Susan Love Research Foundation: CAR-T Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25368676' target='_blank'>Journal Article Abstract: CD70, A Potential Target in Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search?contains=false&q=Aldesleukin' target='_blank'>NCI Drug Dictionary: Aldesleukin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

64

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

Show Scientific Title

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Hospital stay for at least 1 week; follow-up visits for 2 years

ClinicalTrials.gov: NCT02830724

Phase I-II

65

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

Show Scientific Title

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

Purpose: To study a new type of immunotherapy in which researchers take TILs from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient.

Who is this for?: People with metastatic (stage IV) breast cancer and have a tumor that can be surgically removed. View full eligibility criteria

What's involved?

All participants will undergo the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor sample used to grow the tumor infiltrating lymphocyte</li> <li class="seamTextUnorderedListItem">White blood cells-depleting preparative regimen</li> <li class="seamTextUnorderedListItem">Followed by tumor Infiltrating Lymphocytes, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor infiltrating lymphocytes (TILs) are the white blood cells that are found in tumors. </li> <li class="seamTextUnorderedListItem">The immune system has activated these cells to try to control the cancer's growth. </li> <li class="seamTextUnorderedListItem">This study is investigating a new type of immunotherapy in which researchers take TILs from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient. </li> <li class="seamTextUnorderedListItem">Previous studies using TIL in melanoma have shown effectiveness in shrinking the tumor. </li> <li class="seamTextUnorderedListItem">In this study, researchers will study the effectiveness of TIL in shrinking breast (and other) 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/NCT01174121' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT01174121' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.esmo.org/Conferences/Past-Conferences/ESMO-2014-Congress/News-Articles/The-Promise-of-Tumour-Infiltrating-Lymphocytes-for-Cancer-Treatment-and-as-Prognostic-Predictive-Indicators' target='_blank'>ESMO: Tumor Infiltrating Lymphocytes in Melanoma</a> </li></ul>

65

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

Show Scientific Title

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Hospital stay for about 4 weeks

ClinicalTrials.gov: NCT01174121

Phase II

66

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

Show Scientific Title

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Purpose: To study the safety and best dose of gene therapy with KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?: People with KK-LC-1 positive (KK-LC-1+) metastatic (stage IV) breast cancer with a HLA mutation that has progressed on standard treatment. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis procedure</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, daily, 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, daily, 5 days</li> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by injection, 1 session</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily, 4 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for 3-4 weeks</li> <li class="seamTextUnorderedListItem">May require follow-up visits every 3-6 months for up to 5 years</li> <li class="seamTextUnorderedListItem">May require questionnaires for up to 15 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts genetic material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">Gene therapy with KK-LC-1 T cell receptor (TCR) T cells is an experimental type of immunotherapy that trains the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">About 75% of triple negative breast cancer is KK-LC-1 positive.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect specific immune cells called T cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an injection into your tumor.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</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/NCT05035407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=Gene%20therapy%20is%20a%20medical,of%20using%20drugs%20or%20surgery.' target='_blank'>MedlinePlus: What is Gene Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>National Cancer Institute: T Cell Transfer Therapy</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/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-018-24514-9' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>

66

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

Show Scientific Title

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Requires hospitalization

ClinicalTrials.gov: NCT05035407

Phase I

67

MEDI4736 with Lynparza or Cediranib for Advanced Triple Negative Breast Cancer

Show Scientific Title

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?

Participants will be assigned to 1 of 2 groups: Group 1 <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> Group 2 <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 PD-L1 (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>

67

MEDI4736 with Lynparza or Cediranib for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Every 2 weeks for 1 year

ClinicalTrials.gov: NCT02484404

Phase I-II

68

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

Show Scientific Title

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 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 PD-1 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?

You will receive the following: <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 PD-1 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 PD-1 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>

68

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

Show Scientific Title

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

Nearest Location:
2433 miles
Sibley Memorial Hospital
Washington, DC

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

ClinicalTrials.gov: NCT04837209

Phase II

69

CAR T Cell Therapy for Advanced Triple Negative, Mesothelin Expressing Breast Cancer

Show Scientific Title

Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of huCART-meso cells, an experimental CAR T cell therapy.

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

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mesothelin expression testing on your tumor</li> <li class="seamTextUnorderedListItem">huCART-meso cells</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">huCART-meso is an experimental immunotherapy called CAR T cell therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The CAR T cell therapy being used in this study trains the immune system to attack mesothelin expressing 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/NCT05623488' 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></ul>

69

CAR T Cell Therapy for Advanced Triple Negative, Mesothelin Expressing Breast Cancer

Show Scientific Title

Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Breast Cancer

Nearest Location:
2517 miles
University of Pennsylvania
Philadelphia, PA

Visits:
May require hospitalization

ClinicalTrials.gov: NCT05623488

Phase I

70

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

Show Scientific Title

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?

You will be randomly assigned to 1 of 2 groups: Group 1 <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> Group 2 <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 PD-1 inhibitor. It helps the immune system to go after cancer cells by blocking the PD-1 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>

70

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

Show Scientific Title

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

Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

Visits:
8 visits over 2 months

ClinicalTrials.gov: NCT04683679

Phase II

71

Pembrolizumab and Cryoablation for Advanced Triple Negative Breast Cancer

Show Scientific Title

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®) PD-1 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?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Cryoablation</li> </ul> Group 2: Standard of Care <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 PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 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>

71

Pembrolizumab and Cryoablation for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
2539 miles
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

Visits:
Please contact research site

ClinicalTrials.gov: NCT06246968

Phase I

72

KK-LC-1 TCR T Cell Therapy for Metastatic Triple Negative, KK-LC-1 Positive Breast Cancer with a HLA Mutation

Show Scientific Title

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), KK-LC-1 positive (KK-LC-1+) breast cancer with a HLA mutation who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by IV, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily for 1-2 days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells are an experimental immunotherapy that train the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an infusion.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">KK-LC-1 is an abnormal protein that is expressed by certain types of cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: KK-LC-1, HLA</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/NCT05483491' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/treatments/immunotherapy/cellular-immunotherapy/tcr-therapy/' target='_blank'>Moffitt Cancer Center: T-Cell Receptor (TCR) Therapy</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.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>

72

KK-LC-1 TCR T Cell Therapy for Metastatic Triple Negative, KK-LC-1 Positive Breast Cancer with a HLA Mutation

Show Scientific Title

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers

Nearest Location:
2548 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

Visits:
May require hospitalization

ClinicalTrials.gov: NCT05483491

Phase I

73

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

Show Scientific Title

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?

You will receive the following: <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 PD-1.</li> <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>

73

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

Show Scientific Title

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

Nearest Location:
2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

Visits:
5 visits per month, ongoing

ClinicalTrials.gov: NCT04445844

Phase II

74

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

Show Scientific Title

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?

You will receive the following: <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 PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). </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>

74

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

Show Scientific Title

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

Nearest Location:
2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

Visits:
Please contact research site

ClinicalTrials.gov: NCT03428802

Phase II

75

RAPA-201 Immunotherapy for Advanced Triple Negative Breast Cancer

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Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors

Purpose: To determine the safety of RAPA-201 T-cell immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumor has progressed on treatment with an anti-PD-L1 immunotherapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (an apheresis procedure) to be used for the personalized RAPA-201 cell therapy</li> <li class="seamTextUnorderedListItem">Standard-of-care chemotherapy, by IV, once a week for 3 out of every 4 weeks</li> <li class="seamTextUnorderedListItem">RAPA-201, by IV, once a month for 5 months </li> </ul> A hospital stay may be required.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your white blood cells are modified in a lab so they can identify and attack cancer cells. These modified cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">The chemotherapy used in this study is carboplatin and paclitaxel.</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/NCT05144698' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>

75

RAPA-201 Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors

Nearest Location:
2563 miles
Hackensack University Medical Center
Hackensack, NJ

Visits:
3-4 visits per month, for 6 months

ClinicalTrials.gov: NCT05144698

Phase I-II

76

Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited BRCA1/2 or PALB2 Mutation

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SHARON: Study of Metastatic Cancers in Patients With an Inherited Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stem cells with melphalan chemotherapy.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with an inherited (germline) BRCA1, BRCA2, or PALB2 mutation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to collect stem cells</li> </ul> followed by 2 rounds of: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Melphalan, by IV</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), by IV</li> <li class="seamTextUnorderedListItem">Vitamin B12b, by IV</li> <li class="seamTextUnorderedListItem">Vitamin C, by IV</li> <li class="seamTextUnorderedListItem">Ethanol, by IV</li> </ul> followed 2 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stem cells, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your stem cells will be collected from your body and modified in a lab so they can identify and attack cancer cells. These modified stem cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">Apheresis is a procedure to collect your stem cells. </li> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor is a drug that will help prepare your body and stem cells for apheresis.</li> <li class="seamTextUnorderedListItem">Melphalan is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), vitamin B12b, vitamin C, and ethanol will be given to improve the effectiveness of the stem cell infusion.</li> <li class="seamTextUnorderedListItem">You will receive two rounds of melphalan (Alkeran®) chemotherapy and stem cell infusion approximately 6 weeks apart.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2</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/NCT04150042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sharontrial.com/' target='_blank'>General Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/research-clinical-trials/study/117/a-study-of-melphalan-bcnu-vitamin-b12b-vitamin-c-and-stem-cell-infusion-in-people-with-advanced-pancreatic-cancer-and-brca-mutations' target='_blank'>Facing Our Risk of Cancer Empowered: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/autologous-stem-cell-transplant/pyc-20384859' target='_blank'>Mayo Clinic: Autologous Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/stem-cell-transplant/process.html' target='_blank'>American Cancer Society: Getting a Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/melphalan-intravenous-route/side-effects/drg-20071590?p=1#:~:text=Melphalan%20injection%20is%20used%20to,alkylating%20agents%20(cancer%20medicines).' target='_blank'>Mayo Clinic: Melphalan</a> </li></ul>

76

Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited BRCA1/2 or PALB2 Mutation

Show Scientific Title

SHARON: Study of Metastatic Cancers in Patients With an Inherited Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives

Nearest Location:
2567 miles
Memorial Sloan Kettering Cancer Center
New York, NY

Visits:
At least 6 visits, may require hospitalization

ClinicalTrials.gov: NCT04150042

Phase I

77

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

Show Scientific Title

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?

You will receive the following: <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> Please contact research site for treatment schedule

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 PD-1 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>

77

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

Show Scientific Title

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

Nearest Location:
2569 miles
Icahn School of Medicine at Mount Sinai
New York, NY

Visits:
At least 1 visit every 3 weeks

ClinicalTrials.gov: NCT03789097

Phase I-II

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P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

GSK4381562 Immunotherapy for Advanced Breast Cancer

GSK4381562 Immunotherapy for Advanced Breast Cancer

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

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

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

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

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

E-602 Immunotherapy for Advanced Breast Cancer

E-602 Immunotherapy for Advanced Breast Cancer

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

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

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced PD-L1 Positive, Triple Negative Breast Cancer

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced PD-L1 Positive, Triple Negative Breast Cancer

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

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

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

BMS-986340 Immunotherapy for Advanced Breast Cancer

BMS-986340 Immunotherapy for Advanced Breast Cancer

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

NGM831 with Pembrolizumab for Advanced Breast Cancer

NGM831 with Pembrolizumab for Advanced Breast Cancer

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

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

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

KVA12123 Immunotherapy for Advanced Breast Cancer

KVA12123 Immunotherapy for Advanced Breast Cancer

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

GEN1047 for Stage III or Stage IV Breast Cancer

GEN1047 for Stage III or Stage IV Breast Cancer

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

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

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

Immunotherapy and Radiation Therapy for Metastatic HER2 Negative Breast Cancer

Immunotherapy and Radiation Therapy for Metastatic HER2 Negative Breast Cancer

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

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

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

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is PD-L1 Positive

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is PD-L1 Positive

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

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

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy

Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

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

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

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

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

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

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

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

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

BAY3375968 Immunotherapy with PD-1 Inhibitor for Advanced Triple Negative Breast Cancer

BAY3375968 Immunotherapy with PD-1 Inhibitor for Advanced Triple Negative Breast Cancer

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

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

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

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

IMGS-001 Immunotherapy for Advanced Triple Negative Breast Cancer