Trials / Completed
CompletedNCT04100018
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,030 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| DRUG | Prednisone | Specified dose on specified days |
| DRUG | Docetaxel | Specified dose on specified days |
| OTHER | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2020-02-06
- Primary completion
- 2023-06-01
- Completion
- 2024-06-25
- First posted
- 2019-09-23
- Last updated
- 2025-06-12
- Results posted
- 2024-07-22
Locations
293 sites across 28 countries: United States, Argentina, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04100018. Inclusion in this directory is not an endorsement.