A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel
Overview
- Phase
- Phase 3
- Intervention
- Ipilimumab
- Conditions
- Prostate Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 988
- Locations
- 46
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone
Investigators
Eligibility Criteria
Inclusion Criteria
- •Advanced prostate cancer
- •At least 1 bone metastasis
- •Testosterone \< 50 ng/dl
- •Prior treatment with docetaxel
Exclusion Criteria
- •Brain metastasis
- •Autoimmune disease
- •Known HIV, Hep B, or Hep C infection
- •More than 2 prior systemic anticancer regimens for prostate cancer
- •Prior treatment on BMS CA180227 for prostate cancer
Arms & Interventions
Ipilimumab
Intervention: Ipilimumab
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Date of randomization to date of death
OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.
Overall Survival Rate
Time Frame: Date of randomization to date of death
The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Secondary Outcomes
- Progression Free Survival (PFS)(Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death)
- Pain Response(Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit)
- Duration of Pain Response(Day of initial pain response to day of completion of pain response or date of death)
- Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)(Randomization to date of death)
- Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)(Day 1 to 70 days after last dose of study drug)
- Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)(Day 1 to 70 days after last dose of study drug)
- Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)(Day 1 to time of onset of the imAR of interest)
- Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0(Day 1 to 70 days after last dose of study drug)
- Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline(Day 1 to 70 days after last dose of study drug)
- Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline(Day 1 to 70 days after last dose of study drug)
- Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline(Day 1 to 70 days after last dose of study drug)
- Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline(Day 1 to 70 days after last dose of study drug)