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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab
Secondary outcome measures
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

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
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,333 Total Patients Enrolled
80 Trials studying Breast Cancer
132,890 Patients Enrolled for Breast Cancer
OncoPep, Inc.Industry Sponsor
3 Previous Clinical Trials
94 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,764 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,317 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer
Steven J Isakoff, MD, PhD 2016. "Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02826434.
All > Metastatic Triple Negative Breast Cancer > Vaccine
~0 spots leftby Jun 2024
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