Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03036098
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
  • Ipilimumab — BIOLOGICAL
    Specified Dose on Specified Days
  • Gemcitabine — DRUG
    Specified Dose on Specified Days
  • Cisplatin — DRUG
    Specified Dose on Specified Days
  • Carboplatin — DRUG
    Specified Dose on Specified Days

Study Details

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Key Dates

Start date
Mar 24, 2017
Status verified
Feb 2026
Primary completion
Aug 30, 2024
Completion
May 15, 2026

Study Design

Enrollment
1,314 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Investigational immunotherapy
  • Active Comparator: Arm B: Standard of care chemotherapy
  • Experimental: Arm C: Investigational immunotherapy
  • Active Comparator: Arm D: Standard of care chemotherapy

Primary Outcome Measure

Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study [ Time Frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) ]

Locations (29)

FacilityCityStateZIP
Local Institution - 0001AnchorageAlaska99503
Local Institution - 0115FresnoCalifornia93703
St Joseph Heritage HealthcareSanta RosaCalifornia95403
Local Institution - 0051Boca RatonFlorida33486
Local Institution - 0087Fort LauderdaleFlorida33308
Local Institution - 0062JacksonvilleFlorida32256
Local Institution - 0004AthensGeorgia30607
Local Institution - 0033ThomasvilleGeorgia31792
Local Institution - 0046ChicagoIllinois60612
Local Institution - 0117New OrleansLouisiana70121
Local Institution - 0056BostonMassachusetts02210
Local Institution - 0073BostonMassachusetts02215
Local Institution - 0208BostonMassachusetts02215
Local Institution - 0207MilfordMassachusetts01757
Local Institution - 0063Ann ArborMichigan48197
Local Institution - 0002BurnsvilleMinnesota55337
Hattiesburg ClinicHattiesburgMississippi39401
Local Institution - 0032Kansas CityMissouri64111-3220
Local Institution - 0095St LouisMissouri63110
Local Institution - 0057ManchesterNew Hampshire03103
Local Institution - 0084AlbuquerqueNew Mexico87131
Local Institution - 0083BuffaloNew York14263
Local Institution - 0014MineolaNew York11501
Local Institution - 0072New YorkNew York10029
Local Institution - 0116DurhamNorth Carolina27710
Local Institution - 0082ColumbusOhio43210
Local Institution - 0104PortlandOregon97213
Local Institution - 0013PittsburghPennsylvania15212
Local Institution - 0086KirklandWashington98034

Related coverage on Hipa.ai

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