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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Tumor infiltrating Lymphocytes and HER2 specific antibodies

Secondary outcome measures

Rate and severity of Adverse Events

Other outcome measures

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

~2010

0 / 3Eligibility criteria met

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

3,886 Previous Clinical Trials

5,054,544 Total Patients Enrolled

58 Trials studying Breast Cancer

7,525 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03632941 — Phase 2

Frequently Asked Questions

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

Could you provide a summary of any prior investigations involving Pembrolizumab?

"Currently, 961 clinical trials are ongoing for Pembrolizumab with 122 studies at Phase 3. Houston has a concentration of sites operating these tests; however, 35728 different locations have active research initiatives for this drug."

Answered by AI

Has Pembrolizumab acquired official sanction from the FDA?

"Our evaluations rank pembrolizumab's safety as a 2 since it is only in Phase 2 of the clinical trial process. This implies that while there are some data confirming its security, none prove efficacy yet."

Answered by AI

How many participants are currently taking part in this experiment?

"Affirmative. Clinical trials data confirms that this research endeavor, which was initially published on March 1st 2019, is currently seeking participants. This study requires 39 individuals to be enrolled from a single medical site."

Answered by AI

In what clinical scenarios is Pembrolizumab generally prescribed?

"For the treatment of malignant neoplasms, Pembrolizumab is often employed. Additionally, this drug can be helpful for unresectable melanomas, microsatellite instability high cases and patients with chemotherapy-resistant progression."

Answered by AI

Are there any opportunities for individuals to join this research endeavor?

"Indeed, the clinicaltrials.gov website reveals that this medical trial is actively recruiting individuals. It was initially launched on March 1st 2019 and updated as recently as December 4th 2021. There are 39 slots available for patients at a single site."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Stimulation of Oncogene-specific Tumor-infiltrating T Cells Through Combined Vaccine and Αpd-1 Enable Sustained Antitumor Responses Against Established HER2 Breast Cancer

Crosby, Erika J., Chaitanya R. Acharya, Anthony-Fayez Haddad, Christopher A. Rabiola, Gangjun Lei, Jun-Ping Wei, Xiao-Yi Yang, et al.. 2020. “Stimulation of Oncogene-specific Tumor-infiltrating T Cells Through Combined Vaccine and Αpd-1 Enable Sustained Antitumor Responses Against Established HER2 Breast Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-0389.

clinicaltrials.govStudy

A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer

Herbert Lyerly 2019. "A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03632941.

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