A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03138512
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Key Dates

Start date
Jul 7, 2017
Status verified
Nov 2024
Primary completion
Sep 28, 2023
Completion
Feb 1, 2024

Study Design

Enrollment
1,641 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, Arm A: nivolumab + ipilimumab
  • Placebo Comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo
  • Experimental: Part B, Arm A: nivolumab + ipilimumab
  • Placebo Comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo
  • Experimental: Part B, Arm C: nivolumab + ipilimumab placebo

Primary Outcome Measure

Disease-Free Survival (DFS) by BICR - Treatment Part A and B [ Time Frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months) ]

Locations (21)

FacilityCityStateZIPSite coordinators
Local Institution - 0019BirminghamAlabama35205-
Local Institution - 0056SpringdaleArkansas72762-
Local Institution - 0180Los AngelesCalifornia90095-
Local Institution - 0186Los AngelesCalifornia90048-
Local Institution - 0002San FranciscoCalifornia94115-
Local Institution - 0185AuroraColorado80045-
Local Institution - 0016AthensGeorgia30607-
Local InstitutionChicagoIllinois60612-
Local Institution - 0005ChicagoIllinois60611-
Local Institution - 0006St LouisMissouri63110-
Local Institution - 0012Howell TownshipNew Jersey07731-
Local Institution - 0007BuffaloNew York14263-
Local Institution - 0001New YorkNew York10065-
Local Institution - 0181New YorkNew York10029-
Local Institution - 0008ColumbusOhio43210-
Local Institution - 0009PortlandOregon97213-
Local Institution - 0010AllentownPennsylvania18103-
Local Institution - 0014GreenvilleSouth Carolina29607-
Local Institution - 0013ChattanoogaTennessee37404-
Local Institution - 0183NashvilleTennessee37212-
Local Institution - 0057FairfaxVirginia22031-

Find similar trials in Birmingham, AL

By research site
Local Institution - 0019· Birmingham, ALLocal Institution - 0056· Springdale, ARLocal Institution - 0180· Los Angeles, CALocal Institution - 0186· Los Angeles, CALocal Institution - 0002· San Francisco, CALocal Institution - 0185· Aurora, CO

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