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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune Response following treatment with PVX-410 in combination with pembrolizumab
Secondary outcome measures
Incidence of treatment emergent adverse events (safety and tolerability) of PVX-410 in combination with pembrolizumab
Therapeutic procedure
Overall Survival
+2 more

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,335 Total Patients Enrolled
81 Trials studying Breast Cancer
132,912 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,533 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Steven J. Isakoff, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03362060 — Phase 1
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03362060 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions have been addressed with the use of Pembrolizumab?

"Pembrolizumab has been known to effectively treat malignant tumours, irremediable melanoma, and microsatellite instabilities of high levels."

Answered by AI

Is participation in this research endeavor open to new volunteers?

"According to clinicaltrials.gov, the call for participants in this medical trial has ended; initial posting was on December 12th 2017 and the final edit occured on May 6th 2021. Despite its closure, there are 3,324 other trials actively recruiting candidates at this time."

Answered by AI

Are there any safety risks associated with Pembrolizumab for patients?

"Due to the early stage of this clinical trial, there is only scant evidence backing Pembrolizumab's safety and efficacy. Because of that, our team has assigned it a rating of 1 out of 3 on the scale."

Answered by AI

What is the sample size of this trial?

"This research project is currently closed and no longer accepting participants. Despite the study being initially posted on December 12th of 2017, it was last altered on May 6th 2021. Alternatively, 2361 medical studies are actively recruiting patients with triple negative breast neoplasms while 963 trials for Pembrolizumab remain open to enrollment."

Answered by AI

What other analyses have been conducted to assess the effectiveness of Pembrolizumab?

"Currently, there are 963 ongoing clinical trials for Pembrolizumab. Of these studies, 122 have progressed to the third phase of testing. Despite most research originating from Houston, Texas, there is a wide network of 35772 trial sites operating across the world."

Answered by AI
~1 spots leftby Jun 2024