Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment ipilimumab
Phase phase 2
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date December 2014
End date November 2016
Trial size 50 participants
Trial identifier NCT02279862, 2014-002987-34, CA184-437

Summary

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
ipilimumab Yervoy™
(Experimental)
Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
ipilimumab Yervoy™

Primary Outcomes

Measure
Radiologic Progression Free Survival
time frame: Approximately up to 24 months

Secondary Outcomes

Measure
Rate of severe immune-related adverse events (irAEs)
time frame: Up to 90 days after last dose of Ipilimumab
Overall Survival (OS)
time frame: Approximately up to 48 months
Prostate specific antigen progression-free survival (PSA PFS)
time frame: Approximately up to 36 months
Prostate specific antigen response rate
time frame: Approximately up to 48 months
Time to pain progression
time frame: Approximately up to 48 months

Eligibility Criteria

Male participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Prostate cancer with metastases - Prostate cancer should be castration resistant - Progression during hormonal therapy Exclusion Criteria: - Visceral metastases (eg liver, lung or brain metastases) - Prior treatment with any immunotherapy for prostate cancer - Prior or ongoing cytotoxic therapy for prostate cancer - Autoimmune disease - Inadequate hematologic, renal, or hepatic function

Additional Information

Official title A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic
Description Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Response Evaluation Criteria In Solid Tumors (RECIST)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.