NCT00078585

PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Bavarian Nordic · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer. This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC). All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PROSTVAC®-VF/TRICOM™

Timeline

• Start date: 2003-11-01
• Primary completion: 2006-01-04
• Completion: 2009-01-01
• First posted: 2004-03-03
• Last updated: 2017-09-11

Locations

47 sites across 1 country: United States