A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03661320
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Key Dates

Start date
Nov 6, 2018
Status verified
Apr 2026
Primary completion
Feb 16, 2026
Completion
Dec 30, 2027

Study Design

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

Arms

  • Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
  • Experimental: Arm B: Nivolumab + GC Chemotherapy

Primary Outcome Measure

Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approximately 43 months ]

Locations (26)

FacilityCityStateZIPSite coordinators
Local Institution - 0022TucsonArizona85711-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Local Institution - 0021LittletonColorado80120-4413-
Local Institution - 0036PensacolaFlorida32503-
Local Institution - 0004TampaFlorida33612-
Local Institution - 0144AtlantaGeorgia30342-
Local Institution - 0005ChicagoIllinois60637-
Local Institution - 0006PeoriaIllinois61615-
Local Institution - 0181ColumbiaMaryland21044-
Local Institution - 0009BostonMassachusetts02114-
Local Institution - 0166BostonMassachusetts02215-
Local Institution - 0209BostonMassachusetts02215-
Local Institution - 0025MinneapolisMinnesota55404-
Local Institution - 0129MinneapolisMinnesota55455-
Local Institution - 0001OmahaNebraska68198-6840-
Local Institution - 0183OmahaNebraska68130-
Local Institution - 0024Las VegasNevada89169-
Local Institution - 0029AlbanyNew York12208-
Local Institution - 0069Lake SuccessNew York11042-
Local Institution - 0047New YorkNew York10065-
Local Institution - 0191ClevelandOhio44195-
Local Institution - 0028TigardOregon97223-
Local Institution - 0189CharlestonSouth Carolina29425-
Local Institution - 0007NashvilleTennessee37232-
Local Institution - 0030AustinTexas78731-
Local Institution - 0023NorfolkVirginia23502-

Related coverage on Hipa.ai

Find similar trials in Tucson, AZ

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Local Institution - 0022· Tucson, AZUC Davis Comprehensive Cancer Center· Sacramento, CALocal Institution - 0021· Littleton, COLocal Institution - 0036· Pensacola, FLLocal Institution - 0004· Tampa, FLLocal Institution - 0144· Atlanta, GA

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