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PD-1 Inhibitor

PVX-410 + Pembrolizumab for Advanced Breast Cancer

Phase 1

Waitlist Available

Led By Steven J. Isakoff, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HLA A2+ by deoxyribonucleic acid (DNA) sequence analysis

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is studying whether a combination of PVX-410, pembrolizumab, Hiltonol, and Montanide can help to treat triple-negative breast cancer that has spread to other parts of the body and cannot be removed by surgery.

Who is the study for?

This trial is for women over 18 with metastatic Triple Negative Breast Cancer who are HLA-A2+. They must have had at least one prior systemic therapy, not be pregnant or breastfeeding, agree to use birth control if of childbearing potential, and have no active infections like HIV or hepatitis. Participants should not have received certain vaccines or cancer treatments recently and must be in good health with proper organ function.

What is being tested?

The study tests a combination of immunotherapies: PVX-410 vaccine plus Pembrolizumab, along with Hiltonol and Montanide as possible treatments for breast cancer. The goal is to see how well these drugs work together in patients who express the HLA-A2+ molecule.

What are the potential side effects?

Potential side effects may include immune-related reactions such as inflammation in various organs, infusion reactions from the drug administration process, fatigue, flu-like symptoms due to the vaccine components (Hiltonol and Montanide), and possibly allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My DNA test shows I am HLA A2 positive.

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I am fully active or can carry out light work.

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I am a woman aged 18 or older.

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My breast cancer is advanced, cannot be removed by surgery, and meets certain criteria.

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I have had at least one treatment for my breast cancer that has spread or come back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread to my brain or spinal cord.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have an active Tuberculosis infection.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have had lung inflammation treated with steroids.

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I have another cancer that is getting worse or needs treatment.

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I am currently undergoing or planning to start cancer treatment soon.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immune Response following treatment with PVX-410 in combination with pembrolizumab

Secondary study objectives

Incidence of treatment emergent adverse events (safety and tolerability) of PVX-410 in combination with pembrolizumab

Therapeutic procedure

Overall Survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PVX-410Experimental Treatment2 Interventions

* PVX-410 vaccine at W0, 1, 2, 3, 4, and 5 followed by booster PVX-410 vaccine doses at W10 and 28 * Pembrolizumab will be administered every 3 weeks intravenously starting with week 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

PVX-410

2012

Completed Phase 1

~30

0 / 14Eligibility criteria met