A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03141177
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 day
  • Cabozantinib — DRUG
    Specified dose on specified days
  • Sunitinib — DRUG
    Specified dose on specified days.
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Key Dates

Start date
Jul 23, 2017
Status verified
May 2025
Primary completion
Feb 12, 2020
Completion
Jan 16, 2026

Study Design

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

Arms

  • Experimental: Doublet
    Nivolumab and Cabozantinib
  • Active Comparator: Monotherapy
    Sunitinib
  • Experimental: Triplet
    Nivolumab, Ipilimumab, Cabozantinib \*Enrollment to the triplet arm was discontinued by protocol amendment

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months) ]

Locations (30)

FacilityCityStateZIPSite coordinators
Local Institution - 0077DaphneAlabama36526-
Local Institution - 0044GoodyearArizona85338-
Local Institution - 0132TucsonArizona85724-5024-
Local Institution - 0133BakersfieldCalifornia93309-
Local Institution - 0093Los AngelesCalifornia90404-
Local Institution - 0090Redondo BeachCalifornia90277-
Local Institution - 0088San Luis ObispoCalifornia93401-
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454-
Local Institution - 0103AuroraColorado80045-
Local Institution - 0127AthensGeorgia30607-
Local Institution - 0086NewnanGeorgia30265-
Local Institution - 0036ChicagoIllinois60612-
Local Institution - 0042ZionIllinois60099-
Local Institution - 0091Fort WayneIndiana46804-
Local Institution - 0087WichitaKansas67214-
Local Institution - 0037BostonMassachusetts02215-
Local Institution - 0113BostonMassachusetts02114-
Local Institution - 0106Kansas CityMissouri64132-
Local Institution - 0035St LouisMissouri63110-
Local Institution - 0102Las VegasNevada89169-
Local Institution - 0040BuffaloNew York14263-
Local Institution - 0017New YorkNew York10065-
Local Institution - 0067PortlandOregon97239-
Local Institution - 0135AllentownPennsylvania18103-
Local Institution - 0105NashvilleTennessee37203-
Local Institution - 0080AustinTexas78705-
Local Institution - 0075DallasTexas75246-
Local Institution - 0068HoustonTexas77030-
Local Institution - 0078ShermanTexas75090-
Local Institution - 0131NorfolkVirginia23502-

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