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Checkpoint Inhibitor

VRP-HER2 Vaccine + Pembrolizumab for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Herbert Lyerly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have undergone treatment with trastuzumab plus pertuzumab for at least 3 weeks prior to initiation on this study.
Normal cardiac function defined as either a MUGA or ECHO with LVEF in normal institutional range.
Must not have
Has history of (non-infectious) pneumonitis that required steroids or active, non-infectious pneumonitis.
Has a known history of active TB (Bacillus Tuberculosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Summary

This trial is testing a new immunization for HER2 positive breast cancer, given with or without pembrolizumab.

Who is the study for?
Adults over 18 with breast cancer, who've had prior treatment with trastuzumab and pertuzumab, can join this trial. They must have a tumor biopsy available, resolved side effects from previous treatments to mild levels, normal heart function, and be able to use contraception. Exclusions include active brain metastases, certain infections or conditions that could affect the study's outcome or patient safety.
What is being tested?
This phase II trial tests VRP-HER2 vaccinations combined with pembrolizumab in patients with breast cancer. Initially there's a Safety Arm; if safe, participants are randomized into three groups: one receiving just the vaccine (Arm A), another getting only pembrolizumab (Arm B), and the third both treatments (Arm C).
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation of organs due to pembrolizumab and typical vaccination reactions such as soreness or fever from VRP-HER2. Patients may also experience fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with trastuzumab and pertuzumab for at least 3 weeks.
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My heart functions normally, as confirmed by a heart test.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pneumonitis treated with steroids or currently have it.
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I have an active tuberculosis infection.
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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have been diagnosed with HIV.
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I am not currently on systemic therapy for an infection.
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I have an autoimmune disease treated with medication in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Tumor infiltrating Lymphocytes and HER2 specific antibodies
Secondary study objectives
Rate and severity of Adverse Events
Other study objectives
Clinical response rate

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: VRP-HER2 Vaccine + PembrolizumabExperimental Treatment2 Interventions
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Group II: VRP-HER2 VaccineActive Control1 Intervention
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
Group III: PembrolizumabActive Control1 Intervention
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Herbert LyerlyLead Sponsor
4 Previous Clinical Trials
49 Total Patients Enrolled
1 Trials studying Breast Cancer
18 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,974 Total Patients Enrolled
58 Trials studying Breast Cancer
7,399 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03632941 — Phase 2
~1 spots leftby Sep 2025
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