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A Phase 3 Efficacy Study of a Recombinant Vaccinia Virus Vaccine to Treat Metastatic Prostate Cancer

Study:

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

Rationale:

n/a

Purpose:

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.

Study Status: Recruiting

Recruiting:
216-445-8492

Condition Intervention Phase
Prostate Cancer Metastatic Biological: PROSTVAC-V
Biological: PROSTVAC-F
Drug: GM-CSF
Other: GM-CSF Placebo
Biological: Placebo		 Phase 3

Verified by BN ImmunoTherapeutics February, 2013

Sponsored by: BN ImmunoTherapeutics
Information provided by: BN ImmunoTherapeutics
ClinicalTrials.gov identifier: NCT01322490

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

James L. Gulley, MD., Principal Investigator
Philip Kantoff, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.