An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02632409
Phase
PHASE3
Status
Completed

Conditions

  • Various Advanced Cancer

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Key Dates

First listed
Dec 16, 2015
Start date
Mar 22, 2016
Status verified
Jul 2026
Primary completion
Jul 17, 2020
Completion
May 19, 2026

Study Design

Enrollment
709 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab dose as specified
  • Placebo Comparator: Placebo
    Placebo dose as specified

Primary Outcome Measure

Disease Free Survival (DFS) [ Time Frame: approximately up to 48 months ]

Locations (33)

FacilityCityStateZIPSite coordinators
Alaska Urological Institute dba Alaska Clinical Research CenterAnchorageAlaska99503-
Local Institution - 0179TucsonArizona85704-
Local Institution - 0061ClovisCalifornia93611-
Local Institution - 0172SacramentoCalifornia95817-
Local Institution - 0005San FranciscoCalifornia94115-
Local Institution - 0178LakewoodColorado80228-
Local Institution - 0167GainesvilleFlorida32610-
Local Institution - 0030Miami BeachFlorida33140-
Local Institution - 0008TampaFlorida33612-
Local Institution - 0168MaywoodIllinois60153-
Local Institution - 0094Fort WayneIndiana46804-
Local Institution - 0171New OrleansLouisiana70112-
Local Institution - 0173Grand RapidsMichigan49503-
Local Institution - 0051BurnsvilleMinnesota55337-
Local Institution - 0004RochesterMinnesota55905-
Local Institution - 0003OmahaNebraska68130-
Local Institution - 0177Las VegasNevada89148-
Local Institution - 0176AlbanyNew York12208-
Local Institution - 0157BuffaloNew York14263-
Local Institution - 0007MineolaNew York11501-
Local Institution - 0001New YorkNew York10021-
Local Institution - 0006New YorkNew York10029-
Local Institution - 0166Chapel HillNorth Carolina27599-7305-
Local InstitutionDurhamNorth Carolina27708-
Local Institution - 0010PortlandOregon97239-
Local Institution - 0044PortlandOregon97213-
Local Institution - 0180TigardOregon97223-
Local Institution - 0074AllentownPennsylvania18103-
Local Institution - 0011PittsburghPennsylvania15212-
Local Institution - 0040PittsburghPennsylvania15232-
Local Institution - 0169Myrtle BeachSouth Carolina29572-
Local Institution - 0009ChattanoogaTennessee37404-
Local Institution - 0234NorfolkVirginia23502-

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By research site
Alaska Urological Institute dba Alaska Clinical Research Center· Anchorage, AKLocal Institution - 0179· Tucson, AZLocal Institution - 0061· Clovis, CALocal Institution - 0172· Sacramento, CALocal Institution - 0005· San Francisco, CALocal Institution - 0178· Lakewood, CO