A Study to Evaluate Concurrent VRP-HER2 Vaccination & Pembrolizumab for

Status Active, not recruiting

Clinical Trial Summary

In this phase II study, study subjects will receive the VRP-HER2 immunizations plus pembrolizumab. There will be an initial Safety Arm during which subjects will receive the VRP-HER2 immunizations plus pembrolizumab. If there is no dose limiting toxicity in the Safety Arm, then 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.

Clinical Trial Description

The primary objective of this phase II study is to determine whether pembrolizumab increases the tumor infiltrating and peripheral blood immune response to the VRP-HER2 vaccine. The investigators hypothesize that HER2 specific T cell responses and anti-tumor immunity induced with HER2 vaccination will be augmented by concurrent anti-PD-1 antibody therapy. The investigators will additionally determine whether the administration of pembrolizumab is safe in patients with recurrent or metastatic HER2+ cancers who are receiving the anti-HER2 vaccine VRP-HER2. There will be an initial Safety Arm (n=3) during which subjects will receive the VRP-HER2 immunizations plus pembrolizumab and if there is no dose limiting toxicity in the Safety Arm, subjects will then be randomized 1:1:1 into 3 arms (n=12 per arm). Subjects with metastatic HER2 overexpressing breast cancer receiving trastuzumab and pertuzumab will continue these antibodies. 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. Tumor biopsies and peripheral blood draws will be performed following the course of immunizations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03632941
Study type	Interventional
Source	Duke University
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	March 1, 2019
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms