A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02985957
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICALSpecified dose on specified days
- Ipilimumab — BIOLOGICALSpecified dose on specified days
- Cabazitaxel — DRUGSpecified dose on specified days
- Prednisone — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).
Key Dates
- Start date
- Mar 26, 2017
- Status verified
- Dec 2025
- Primary completion
- Apr 5, 2022
- Completion
- Jan 7, 2025
Study Design
- Enrollment
- 351 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort A (Arm A)
- Experimental: Cohort B (Arm B)
- Experimental: Cohort C (Arm C)
- Experimental: Cohort D (Arm D1)
- Experimental: Cohort D (Arm D2)
- Experimental: Cohort D (Arm D3)
- Experimental: Cohort D (Arm D4)
Primary Outcome Measure
Objective Response Rate (ORR) Cohorts B and C Per BICR [ Time Frame: From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months) ]
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0074 | Tucson | Arizona | 85711 | - |
| Local Institution - 0046 | Marietta | Georgia | 30060 | - |
| Local Institution - 0011 | Chicago | Illinois | 60637 | - |
| Local Institution - 0076 | Minneapolis | Minnesota | 55404 | - |
| Local Institution - 0008 | St Louis | Missouri | 63110 | - |
| Local Institution - 0075 | Las Vegas | Nevada | 89169 | - |
| Local Institution - 0078 | Albany | New York | 12208 | - |
| Local Institution - 0065 | Lake Success | New York | 11042 | - |
| Local Institution - 0001 | New York | New York | 10029 | - |
| Local Institution - 0077 | Tigard | Oregon | 97223 | - |
| Local Institution - 0047 | Allentown | Pennsylvania | 18105 | - |
| Local Institution - 0010 | Philadelphia | Pennsylvania | 19104 | - |
| Local Institution - 0067 | Charleston | South Carolina | 29425 | - |
| Local Institution - 0079 | Austin | Texas | 78731 | - |
| Local Institution - 0002 | Houston | Texas | 77030 | - |
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