Clinical Trial: NCT04100018
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2025-06-12 |
Study Overview
Brief 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.
Official Title
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Conditions
Prostate Cancer
Intervention / Treatment
- Biological: Nivolumab
- Drug: Prednisone
- Drug: Docetaxel
- Other: Placebo
Other Study ID Numbers
- CA209-7DX
- 2019-002030-36
- 2019
Start Date (Actual)
2020-02-06
Primary Completion Date (Actual)
2023-06-01
Study Completion Date (Actual)
2024-06-25
Enrollment (Actual)
1030
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2025-06-12 |
Study Overview
Brief 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.
Official Title
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Conditions
Prostate Cancer
Intervention / Treatment
- Biological: Nivolumab
- Drug: Prednisone
- Drug: Docetaxel
- Other: Placebo
Other Study ID Numbers
- CA209-7DX
- 2019-002030-36
- 2019
Start Date (Actual)
2020-02-06
Primary Completion Date (Actual)
2023-06-01
Study Completion Date (Actual)
2024-06-25
Enrollment (Actual)
1030
Study Type
Interventional
Phase
Phase 3