A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02982954
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Specified dose on specified day
  • Ipilimumab — DRUG
    Specified Dose on Specified Day

Study Details

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.

Key Dates

Start date
Jan 16, 2017
Status verified
Oct 2022
Primary completion
May 11, 2020
Completion
Oct 6, 2021

Study Design

Enrollment
211 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ccRCC KPS ≥ 70%
    Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
  • Experimental: Non-ccRCC, KPS ≥ 70%
    Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
  • Experimental: RCC with non-active Brain Mets, KPS ≥70%
    Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
  • Experimental: any RCC with KPS 50%-60%
    Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%

Primary Outcome Measure

Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs) [ Time Frame: Approximately 39 Months ]

Locations (61)

FacilityCityStateZIPSite coordinators
Northwest Alabama Cancer Center, PcMuscle ShoalsAlabama35661-
Alaska Urological Institute dba Alaska Clinical Research CenterAnchorageAlaska99503-
Ironwood Cancer And Research Centers, PcChandlerArizona85224-
Local Institution - 0028FayettevilleArkansas72703-
eCareEncinitasCalifornia92024-
Pacific Shores Medical GroupLong BeachCalifornia90813-
Los Angeles Cancer NetworkLos AngelesCalifornia90017-
UCLA Hematology OncologyLos AngelesCalifornia90095-
Torrance Health AssociationRedondo BeachCalifornia90277-
Kaiser Permanente Medical Group - Southern CaliforniaRiversideCalifornia92505-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Coastal Integrative Cancer CareSan Luis ObispoCalifornia93401-
Central Coast Med OncologySanta MariaCalifornia93454-
Florida Cancer Specialists S.Fort MyersFlorida33901-
University Of Miami/Sylvester Cancer CenterMiamiFlorida33136-
UF Health Cancer Center at Orlando HealthOrlandoFlorida32806-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Emory University - Winship Cancer InstituteAtlantaGeorgia30322-
Illinois Cancer SpecialistsNilesIllinois60714-
Local Institution - 0012Fort WayneIndiana46845-
Cancer Center Of KansasWichitaKansas67214-
Norton Cancer InstituteLouisvilleKentucky40202-
Southdale Cancer ClinicBurnsvilleMinnesota55337-
Local Institution - 0009Coon RapidsMinnesota55433-
Park Nicollet Clinic Cancer CenterMinneapolisMinnesota55416-
Hattiesburg ClinicHattiesburgMississippi39401-
Jackson Oncology Associates, PllcJacksonMississippi39202-
HCA Midwest DivisionKansas CityMissouri64132-
Comprehensive Cancer Centers of NevadaLas VegasNevada89148-
Local Institution - 0023HackensackNew Jersey07601-
University Of New MexicoAlbuquerqueNew Mexico87106-
Maimonides Medical CenterBrooklynNew York11220-
St. Francis Cancer Treatment CenterGrand IslandNew York68803-
Broome OncologyJohnson CityNew York13790-
Local Institution - 0052New YorkNew York10016-
Weill Cornell Medical CollegeNew YorkNew York10021-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10461-
Duke University Medical CenterDurhamNorth Carolina27710-
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27534-
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical ResearchTulsaOklahoma74146-
Local Institution - 0071PittsburghPennsylvania15240-
Charleston Hematology Oncology Associates, PaCharlestonSouth Carolina29414-
Hollings Cancer CenterCharlestonSouth Carolina29425-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Tennessee Oncology, PLLC - SCRI - PPDSChattanoogaTennessee37404-
Local Institution - 0002NashvilleTennessee37203-1624-
Vanderbilt University Medical CenterNashvilleTennessee37232-6307-
Texas OncologyAustinTexas78731-
Texas OncologyDallasTexas75246-
Texas Oncology-Fort Worth 12th AveFort WorthTexas76104-
Texas Oncology-Midland Allison Cancer CenterMidlandTexas79701-
Texas OncologySan AntonioTexas78217-
University of Virginia Health SystemCharlottesvilleVirginia22936-
Local Institution - 0042FairfaxVirginia22031-
Bon Secours St Francis HospitalMidlothianVirginia23114-
Virginia Cancer InstituteRichmondVirginia23226-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-
Medical Oncology AssociatesSpokaneWashington99208-
Yakima Valley Memorial Hospital/North Star LodgeYakimaWashington98902-
University of Wisconsin Clinical Science CenterMadisonWisconsin53705-

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Northwest Alabama Cancer Center, Pc· Muscle Shoals, ALAlaska Urological Institute dba Alaska Clinical Research Center· Anchorage, AKIronwood Cancer And Research Centers, Pc· Chandler, AZLocal Institution - 0028· Fayetteville, AReCare· Encinitas, CAPacific Shores Medical Group· Long Beach, CA

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