drugset / Trial / NCT01322490

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

NCT01322490

Phase 3 Completed 1297 enrolled Bavarian Nordic
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

Timeline

Start
2011-11-28
Primary completion
2017-09-25
Completion
2017-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PROSTVAC-F Vaccine
Subject PROSTVAC-V Vaccine
Subject sargramostim Protein / enzyme biologic