Clinical Trials

pTVG-HP [MVI-816] DNA Vaccine With or Without pTVG-AR [MVI-118] DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer

NCT04090528

Identifier

NCT04090528

Protocol Principal Investigator

Douglas McNeel, MD, PhD

Location(s)

University of Wisconsin Carbone Cancer Center
Washington University Siteman Cancer Center

Purpose

This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until radiographic progression) on the treatment of castrate-resistant, metastatic prostate cancer. The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a greater frequency and magnitude of tumor-directed CD8+ T cells, and thereby increase the percentage of patients experiencing objective anti-tumor effect as measured by PSA declines and/or objective radiographic responses. Participants must be 18 years of age or older and can expect to be on treatment for 2 years (32 cycles) and on study for up to 4 years (including 2 years of follow up via phone).

Start Date

October 21, 2019

Estimated Primary Completion Date

December 21, 2021

Estimated  Completion Date

December 21, 2023

Sponsors/Collaborators

University of Wisconsin-Madison
Merck Sharpe & Dohme Corp.
Madison Vaccines, Inc (MVI)
Prostate Cancer Foundation

Interested in participating? Contact the UW Carbone Cancer Center