CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 988 enrolled
Drug / intervention
Ipilimumab +1 moredrug
Likely dose
Ipilimumab 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00861614
NCT00861614Phase 3Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Mar 13, 2009·Updated Sep 30, 2016

In Brief

A Phase 3 clinical trial evaluating Ipilimumab and Placebo for Prostate Cancer. Completed, enrolled 988 participants across 158 sites in 27 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Peru, Poland, Puerto Rico, Romania, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2009
Enrollment StartMay 1, 2009
Primary CompletionNov 1, 2012
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.3 years ago

Interventions

Ipilimumabdrug

5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure

Placebodrug

Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure