Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)

Part of paid clinical trials in Duarte, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01472081
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.

Key Dates

Start date
Feb 9, 2012
Status verified
Nov 2021
Primary completion
Feb 2, 2016
Completion
Jun 3, 2021

Study Design

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

Arms

  • Experimental: Arm S: Nivolumab + Sunitinib
    Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons Sunitinib 50 mg capsule by mouth on Days 1-28 of 42 day cycle until Progressive disease (PD), toxicity or discontinue for other reasons
  • Experimental: Arm P: Nivolumab + Pazopanib
    Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons Pazopanib 800 mg tablet by mouth daily until Progressive disease (PD), toxicity or discontinue for other reasons
  • Experimental: Arm I-1: Nivolumab + Ipilimumab
    Nivolumab 3 mg/kg solution intravenously (IV) every 21 days during Induction phase and every 14 days during Maintenance phase until Progressive disease (PD), toxicity or discontinue for other reasons Ipilimumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase (Ipilimumab will not be administered during Maintenance phase) until Progressive disease (PD), toxicity or discontinue for other reasons
  • Experimental: Arm I-3: Nivolumab + Ipilimumab
    Nivolumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase
  • Experimental: Arm IN-3: Nivolumab+Ipilimumab
    Nivolumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase

Primary Outcome Measure

Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation [ Time Frame: From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months) ]

Locations (10)

FacilityCityStateZIPSite coordinators
City Of HopeDuarteCalifornia91010-3000-
Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Memorial Sloan Kettering NassauNew YorkNew York10065-
Blumenthal Cancer CenterCharlotteNorth Carolina28204-
Cleveland ClinicClevelandOhio44195-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Tennessee Oncology, PLLCNashvilleTennessee37203-
University Of Texas M.D. Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Duarte, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
City Of Hope· Duarte, CASidney Kimmel Comprehensive Cancer Center At Johns Hopkins· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MADartmouth-Hitchcock Medical Center· Lebanon, NHMemorial Sloan Kettering Nassau· New York, NYBlumenthal Cancer Center· Charlotte, NC

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