At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,030 enrolled
Drug / intervention
Nivolumab +3 morebiological
Likely dose
Not stated in 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.
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Prednisone, and 2 other interventions for Prostate Cancer. Completed, enrolled 1,030 participants across 293 sites in 28 countries.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartFeb 2020
Primary CompletionJun 2023
Study CompletionJun 2024
TodayJul 2026
First PostedSep 23, 2019
Enrollment StartFeb 6, 2020
Primary CompletionJun 1, 2023
Study CompletionJun 25, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.8 years ago
Interventions
Nivolumabbiological
Specified dose on specified days
Prednisonedrug
Specified dose on specified days
Docetaxeldrug
Specified dose on specified days
Placeboother
Specified dose on specified days