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

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)

FacilityCityStateZIPSite coordinators
Local Institution - 0013Washington D.C.District of Columbia20007-
Local Institution - 0053AthensGeorgia30607-
Local Institution - 0066BostonMassachusetts02114-
Local Institution - 0086BostonMassachusetts02215-
Local Institution - 0088BostonMassachusetts02114-
The Reading Hosp Med Ctr Reg Cancer CtrWest ReadingPennsylvania19611-
Local Institution - 0084CharlestonSouth Carolina29414-

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