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NCT03632941 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Cancer and HER2 + Breast Cancer, sponsored by Herbert Lyerly.

Active
Registry status
Phase 2
Development phase
8
Enrollment target
1
Study location

NCT03632941: Active Phase 2 study of Breast Cancer and HER2 + Breast Cancer, sponsored by Herbert Lyerly.

NCT03632941 is a Phase 2 study of Breast Cancer and HER2 + Breast Cancer that is active but no longer recruiting, run by Herbert Lyerly. The registered enrollment target is 8 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03632941, a Phase 2 study of Breast Cancer and HER2 + Breast Cancer, is active but no longer recruiting, sponsored by Herbert Lyerly.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

In this phase II study, participants will receive the VRP-HER2 immunizations plus pembrolizumab. Subjects will be randomized into 3 arms. They will undergo a biopsy of their tumor and peripheral blood draw for immune cell analyses and be assigned to the applicable arm of the study. Arm A will consist of the the VRP-HER2 immunizations; Arm B will consist of pembrolizumab; Arm C will consist of the VRP-HER2 immunizations plus pembrolizumab.

Primary Outcome

The enzyme-linked immunosorbent spot (ELISpot) assay is a quantitative method that measures the frequency of cytokine secretion in a single cell.

Conditions Studied

Breast Cancer HER2 + Breast Cancer

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL VRP-HER2

Study Locations (1)

North Carolina

  • Duke University - Durham

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2019-03-01
Est. Completion 2025-12
Phase Phase 2
Herbert Lyerly

4 total trials

What the registry record for NCT03632941 still lists

NCT03632941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT03632941 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03632941 about?

NCT03632941 is a clinical study titled "A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer". In this phase II study, participants will receive the VRP-HER2 immunizations plus pembrolizumab. Subjects will be randomized into 3 arms. They will undergo a biopsy of their tumor and peripheral blood draw for immune cell analyses and be assigned to the applicable arm of the study. Arm A will consis...

What is the current status of trial NCT03632941?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2019-03-01. Estimated completion is 2025-12.

What conditions does trial NCT03632941 study?

This clinical trial studies the following conditions: Breast Cancer, HER2 + Breast Cancer.

What interventions are being tested in trial NCT03632941?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), VRP-HER2 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03632941?

This trial is sponsored by Herbert Lyerly, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03632941 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03632941's enrollment target sits among peer trials

8 1196th of 1224 higher than 24 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03632941, the US trial registry maintained by the National Library of Medicine. NCT03632941 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.