GUMDROP : NCI-11-C-0262 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V,F ± GM-CSF in Men with Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Created by Marte, Jenn (NIH/NCI) [E], last modified by Nancy Dawson on Jun 27, 2013

Description:

BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls. The primary endpoint is overall survival over approximately 5 years.

Link:

ClinicalTrials.gov

Site:

NIH

Principal Investigator:

Dr. James Gulley, MD