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PVX-410 + Durvalumab for Triple Negative Breast Cancer

Phase 1

Waitlist Available

Led By Steven 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 positive by deoxyribonucleic acid (DNA) sequence analysis (by history or as part of this study).

Histopathological diagnosis of triple negative breast cancer(TNBC) (ductal, lobular, mixed or metaplastic), defined as estrogen receptor (ER)<1%, progesterone receptor (PR)<1%, and Human Epidermal growth factor Receptor 2 (HER2) negative according to American Society of Clinical Oncology/College of American Pathologists guidelines by local testing according to institutional standards.

Must not have

Stage IV disease, confirmed by biopsy or unequivocal radiographic evidence.

Ongoing or planned systemic anti-cancer therapy or radiation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trialis researching Immunotherapy as a possible adjuvant treatment for Triple Negative Breast Cancer. It will look at safety, tolerability, and immune response.

Who is the study for?

This trial is for women over 18 with Stage II or III Triple Negative Breast Cancer who've finished their planned cancer therapy. They must not have HIV, hepatitis B/C, autoimmune diseases, or certain medical conditions that could affect the study. Participants need to be HLA-A2 positive and willing to use birth control if they can have children.

What is being tested?

The trial tests a combination of PVX-410 vaccine and Durvalumab (MEDI4736), a PD-L1 inhibitor, as additional treatment after standard care for breast cancer. It aims to assess safety, tolerability, and how well the immune system responds to these treatments in patients.

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccine and immune-related issues due to Durvalumab such as inflammation in various organs. Fatigue and digestive problems may also occur.

Eligibility Criteria

Inclusion Criteria

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

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My genetic test shows I am HLA-A2 positive.

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My breast cancer is triple negative, not responding to hormones or HER2.

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I have finished all treatments for Stage II or III triple-negative breast cancer.

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I am fully active or can carry out light work.

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I am not pregnant or cannot become pregnant.

Exclusion Criteria

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

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My cancer is stage IV, confirmed by tests.

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

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I have or had Crohn's disease or ulcerative colitis.

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I received my last cancer treatment less than 4 weeks ago, or more than 6 months ago.

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I have no lasting side effects from cancer treatment above mild.

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I have been treated with a PD1 or PD-L1 inhibitor before.

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My cancer has a type known for better outcomes.

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I have or had an autoimmune disease that needed treatment.

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I haven't taken immunosuppressive drugs in the last 28 days, except for allowed ones.

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I have received an organ transplant from another person.

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

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I have been previously diagnosed with tuberculosis.

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I weigh less than 30 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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

Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab

Secondary study objectives

Adverse events according to Common Toxicology Criteria for Adverse Events (CTCAE 4.0) will be assessed for the PVX-410 vaccine regimen alone versus PVX-410 vaccine regimen plus durvalumab

Disease-Free Survival

Immune Response Rate of cluster designation 8 (CD8)+ Cytotoxic T Lymphocytes (CTLs) to Vaccine-Specific Peptides

Awards & Highlights

All Individual Drugs Already Approved

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

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PVX-410 and DurvalumabExperimental Treatment3 Interventions

Each patient will receive 6 PVX-410 vaccine injections and 2 infusions of Durvalumab. * The injection of PVX-410 will be co-administered with Hiltonol every 2 weeks for 6 injections. * The infusion of Durvalumab will be given on the day of the 4th and 6th PVX-410 injection, for a total of 2 infusions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PVX-410

2012

Completed Phase 1

~30

Durvalumab

FDA approved

Hiltonol

2015