A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT03873402
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICALSpecified dose on specified days
- Ipilimumab — BIOLOGICALSpecified dose on specified days
- Ipilimumab placebo — OTHERSpecified dose on specified days
Study Details
The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
Key Dates
- Start date
- Jun 21, 2019
- Status verified
- Jan 2026
- Primary completion
- Mar 11, 2027
- Completion
- Mar 11, 2027
Study Design
- Enrollment
- 437 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab + ipilimumab
- Experimental: Nivolumab + ipilimumab placebo
Primary Outcome Measure
Progression free survival (PFS) by blinded independent central review (BICR) [ Time Frame: Up to 34 months ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0013 | Washington D.C. | District of Columbia | 20007 | - |
| Local Institution - 0053 | Athens | Georgia | 30607 | - |
| Local Institution - 0066 | Boston | Massachusetts | 02114 | - |
| Local Institution - 0086 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0088 | Boston | Massachusetts | 02114 | - |
| The Reading Hosp Med Ctr Reg Cancer Ctr | West Reading | Pennsylvania | 19611 | - |
| Local Institution - 0084 | Charleston | South Carolina | 29414 | - |
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