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

Not Applicable

• Conditions: -C61 Malignant neoplasm of prostate; Malignant neoplasm of prostate; C61

• Registration Number: PER-060-09
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name: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.<br><br>Measure:Overall Survival (OS)<br>Timepoints:Date of randomization to date of death<br>;<br>Outcome name: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.<br><br>Measure:Overall Survival Rate<br>Timepoints:Date of randomization to date of death<br>