A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)
The purpose of this study is to test 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 Type: Interventional (Clinical Trial)
Estimated Enrollment: 984 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date: December 16, 2019
Estimated Primary Completion Date: February 20, 2023
Estimated Study Completion Date: May 14, 2024
Arms:
- Experimental: Arm A: (nivolumab + docetaxel + prednisone)
- Active Comparator: Arm B: (placebo + docetaxel + prednisone)
| Category | Value |
|---|---|
| Date last updated at source | 2019-09-23 |
| Study type(s) | Interventional |
| Expected enrolment | 984 |
| Study start date | 2019-12-16 |
| Estimated primary completion date | 2023-02-20 |