Overview

This trial is active, not recruiting.

Condition prostate cancer metastatic
Treatments prostvac-v, prostvac-f, gm-csf, gm-csf placebo, placebo
Phase phase 3
Sponsor Bavarian Nordic, Inc.
Start date December 2011
End date June 2017
Trial size 1298 participants
Trial identifier NCT01322490, BNIT-PRV-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF
prostvac-v
prostvac-f
gm-csf
(Experimental)
PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF placebo
prostvac-v
prostvac-f
gm-csf placebo
(Placebo Comparator)
PROSTVAC V/F Placebo + GM-CSF Placebo
gm-csf placebo
placebo
PROSTVAC V/F Placebo

Primary Outcomes

Measure
Overall survival
time frame: Survival will be assessed over the life of the study

Secondary Outcomes

Measure
Proportion of event-free patients compared with placebo
time frame: Events will be measured at baseline and 6 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression). 1. Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer. OR 2. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria). Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated). Exclusion Criteria: Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed). Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F. History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.

Additional Information

Official title 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
Principal investigator James L. Gulley, MD
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. Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are: 1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF 2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo 3. (Arm P) Double placebo
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Bavarian Nordic, Inc..