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1

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

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen <span class="highlight">Vaccine</span> 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) <span class="highlight">vaccine</span> 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?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of <span class="highlight">vaccine</span> used in this trial is called a personalized synthetic long peptide (SLP) <span class="highlight">vaccine.</span> 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>
1

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

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

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Visits:
Number of visits varies, ongoing

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ClinicalTrials.gov: NCT03606967

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Phase II

2

Personalized <span class="highlight">Vaccine</span> with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen <span class="highlight">Vaccine</span> in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental <span class="highlight">vaccine</span> with immunotherapy.

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

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide <span class="highlight">vaccines</span> are an experimental type of immunotherapy. The <span class="highlight">vaccine</span> is designed to target certain proteins (neoantigens) on tumor 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">Poly ICLC is an immunotherapy that stimulates your immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05098210' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
2

Personalized <span class="highlight">Vaccine</span> with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

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

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

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ClinicalTrials.gov: NCT05098210

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Phase I

3

A <span class="highlight">Vaccine</span> Injected Directly Into a Tumor for Metastatic Breast Cancer

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 <span class="highlight">vaccine</span> 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?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MV-s-NAP <span class="highlight">vaccine,</span> 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 <span class="highlight">vaccine</span> 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>
3

A <span class="highlight">Vaccine</span> Injected Directly Into a Tumor for Metastatic Breast Cancer

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

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Visits:
1 visit every 3 weeks for 2.5 months

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ClinicalTrials.gov: NCT04521764

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Phase I

4

<span class="highlight">Vaccine</span> for Metastatic HER2+, HER2 Low, or EGFR+ Breast Cancer

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide <span class="highlight">Vaccine</span> Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of an experimental HER2 B cell peptide <span class="highlight">vaccine.</span>

Who is this for?: People with advanced HER2 positive (HER2+), HER2 low, and/or EGFR positive (EGFR+) breast cancer who have received at least 1 line of therapy for advanced disease. You must not have received more than 3 lines of chemotherapy in the last 2 years. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 B cell peptide <span class="highlight">vaccine,</span> by injection, 3 visits within 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 B cell peptide <span class="highlight">vaccine</span> booster, by injection, every 6 months (optional)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The HER2 B cell peptide <span class="highlight">vaccine</span> is an experimental <span class="highlight">vaccine</span> designed to stimulate your immune system to go after and kill HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</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/NCT06414733' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancer.iu.edu/patients/clinical-trials/61428' target='_blank'>Indiana University: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/immune-system/vaccines' target='_blank'>Breastcancer.org: Breast Cancer and Vaccines</a> </li></ul>
4

<span class="highlight">Vaccine</span> for Metastatic HER2+, HER2 Low, or EGFR+ Breast Cancer

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide <span class="highlight">Vaccine</span> Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors
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Nearest Location:
1946 miles
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, IN

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Visits:
At least 3 visits within 3 months

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ClinicalTrials.gov: NCT06414733

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Phase I

5

Dendritic Cell <span class="highlight">Vaccine</span> and Pembrolizumab for Metastatic Triple Negative and HER2+ Breast Cancer With Brain Metastasis

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

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

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

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the brain is called brain metastasis.</li> <li class="seamTextUnorderedListItem">The dendritic cell <span class="highlight">vaccine</span> is a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an experimental type of immunotherapy called a 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/NCT04348747' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org: About Breast Cancer Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancer.org: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy' target='_blank'>Roswell Park Comprehensive Cancer Center Press Release: Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer</a> </li></ul>
5

Dendritic Cell <span class="highlight">Vaccine</span> and Pembrolizumab for Metastatic Triple Negative and HER2+ Breast Cancer With Brain Metastasis

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

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT04348747

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Phase II

6

Personalized <span class="highlight">Vaccine</span> with Pembrolizumab for Advanced Breast Cancer

A Phase I Pilot Study of Personalized Neoantigen Peptide-Based <span class="highlight">Vaccine</span> 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 <span class="highlight">vaccine,</span> 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?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The neoantigen peptide <span class="highlight">vaccine</span> will be personalized to your cancer based on your blood and biopsy results.</li> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide <span class="highlight">vaccines</span> are an experimental type of immunotherapy.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">vaccine</span> 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 <span class="highlight">vaccine,</span> you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the <span class="highlight">vaccine.</li></span> <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>
6

Personalized <span class="highlight">Vaccine</span> with Pembrolizumab for Advanced Breast Cancer

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

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

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ClinicalTrials.gov: NCT05269381

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Phase I-II

7

MEM-288 <span class="highlight">Vaccine</span> for Advanced Triple Negative Breast Cancer

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

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MEM-288, an experimental <span class="highlight">vaccine.</span>

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?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 is a <span class="highlight">vaccine</span> 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>
7

MEM-288 <span class="highlight">Vaccine</span> for Advanced Triple Negative Breast Cancer

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

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

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ClinicalTrials.gov: NCT05076760

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Phase I

8

Dendritic Cell <span class="highlight">Vaccine</span> and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental dendritic cell <span class="highlight">vaccine</span> with elacestrant (Orserdu®) hormone therapy.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2- or HER2 low) breast cancer with ESR1 mutations. You must have received a CDK4/6 inhibitor with hormone therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell <span class="highlight">vaccine,</span> by injection, weekly for 2 months then monthly for 3 months</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell <span class="highlight">vaccine</span> is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell <span class="highlight">vaccine</span> made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after cancer cells with ESR1 mutations, and then they will be injected as a <span class="highlight">vaccine.</li></span> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</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/NCT06691035' target='_blank'>ClinicalTrials.gov</a> </li></ul>
8

Dendritic Cell <span class="highlight">Vaccine</span> and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer
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Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
Weekly for 2 months then monthly for 3 months

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ClinicalTrials.gov: NCT06691035

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Phase I

9

T-Cell Therapy, Dendritic Cell <span class="highlight">Vaccine</span> & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell <span class="highlight">Vaccine</span> and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of T-cell therapy after dendritic cell <span class="highlight">vaccines</span> with pepinemab, an experimental targeted therapy, and trastuzumab (Herceptin®), a HER2-targeted therapy.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that progressed on trastuzumab (Herceptin®). You must not have received more than 3 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell <span class="highlight">vaccine,</span> by injection, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Pepinemab, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> followed by (2 weeks after last <span class="highlight">vaccine):</span> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">T-cell therapy, by IV, 2 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">Dendritic cell <span class="highlight">vaccine,</span> by injection, every 3 weeks for at least 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis to collect your T cells</li> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a type of immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your T-cells are removed from your body during a process called leukapheresis, modified with CD4+ that allows them to attack HER2 positive cancer cells, and then infused back into your body.</li> <li class="seamTextUnorderedListItem">Before you receive the T-cells, you will be treated with the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your body to receive the T-cells.</li> <li class="seamTextUnorderedListItem">Dendritic cell <span class="highlight">vaccines</span> are a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pepinemab is an experimental targeted therapy called a SEMA4D inhibitor. Blocking SEMA4D may stop or slow cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">After receiving the modified T-cells, you will continue to receive pepinemab, trastuzumab (Herceptin®), and booster doses of the dendritic cell <span class="highlight">vaccine</span> every 3 weeks.</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/NCT05378464' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cell-therapy' target='_blank'>National Cancer Institute: Adoptive T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vaccinex.com/pipeline/pepinemab-immuno-oncology/' target='_blank'>Vaccinex Drug Information Page: Pepinemab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
9

T-Cell Therapy, Dendritic Cell <span class="highlight">Vaccine</span> & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell <span class="highlight">Vaccine</span> and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer
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Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
May require hospital stay

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ClinicalTrials.gov: NCT05378464

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Phase I

10

Dendritic Cell <span class="highlight">Vaccine</span> for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease

A First in Human Dose Escalation of Dendritic Cell <span class="highlight">Vaccine</span> (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of a dendritic cell <span class="highlight">vaccine.</span>

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer with leptomeningeal disease (LMD). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Procedure to place Ommaya reservoir</li> <li class="seamTextUnorderedListItem">Dendritic cell <span class="highlight">vaccine,</span> by Ommaya reservoir, weekly for 1.5-3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the leptomeninges is called leptomeningeal disease (LMD).</li> <li class="seamTextUnorderedListItem">The dendritic cell <span class="highlight">vaccine</span> is a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF), the fluid or liquid surrounding your brain and spinal cord.</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/NCT05809752' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancer.org: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are' target='_blank'>Cancer Research UK: Leptomeningeal Metastasis</a> </li></ul>
10

Dendritic Cell <span class="highlight">Vaccine</span> for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease

A First in Human Dose Escalation of Dendritic Cell <span class="highlight">Vaccine</span> (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)
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Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
1 visit every week for 1.5-3 months

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ClinicalTrials.gov: NCT05809752

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Phase I

11

T Cell Therapy with a <span class="highlight">Vaccine</span> for Metastatic Breast Cancer with KRAS Mutations

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 <span class="highlight">Vaccine</span> 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 <span class="highlight">vaccine.</span>

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?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> <p class="seamTextPara"> followed by: </p> <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"><span class="highlight">Vaccine,</span> 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 <span class="highlight">vaccine</span> 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>
11

T Cell Therapy with a <span class="highlight">Vaccine</span> for Metastatic Breast Cancer with KRAS Mutations

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 <span class="highlight">Vaccine</span> Directed Against These Antigens in Participants With Metastatic Cancer
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization for 3-4 weeks

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ClinicalTrials.gov: NCT06253520

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Phase I

12

Immunotherapy <span class="highlight">Vaccine,</span> Radiation and Pembrolizumab for Metastatic Breast Cancer

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

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

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

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapies injected into the metastases are flt3L and poly-ICLC. </li> <li class="seamTextUnorderedListItem">Flt3L is an immune cell growth factor. It gets the body to make more immune cells. </li> <li class="seamTextUnorderedListItem">Poly-ICLC is an immune cell activating factor. It turns on the immune cells that have been brought to the tumor by flt3L. </li> <li class="seamTextUnorderedListItem">Radiation therapy will be targeted at the same metastases as these immunotherapies.</li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a 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>
12

Immunotherapy <span class="highlight">Vaccine,</span> Radiation and Pembrolizumab for Metastatic Breast Cancer

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

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT03789097

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Phase I-II

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