BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

Part of paid clinical trials in La Jolla, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01354431
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • nivolumab — BIOLOGICAL
    Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
  • nivolumab — BIOLOGICAL
    Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
  • nivolumab — BIOLOGICAL
    Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Study Details

The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.

Key Dates

Start date
May 31, 2011
Status verified
May 2022
Primary completion
May 15, 2013
Completion
Apr 15, 2021

Study Design

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

Arms

  • Experimental: Arm 1: nivolumab - 0.3 mg/kg
  • Experimental: Arm 2: nivolumab - 2.0 mg/kg
  • Experimental: Arm 3: nivolumab - 10.0 mg/kg

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to disease progression or death (up to approximately 2 years) ]

Locations (34)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterLa JollaCalifornia92093-
Samuel Oschin Comprehensive Cancer Inst.Los AngelesCalifornia90048-
UclaLos AngelesCalifornia90024-
Stanford Cancer CenterStanfordCalifornia94305-
University Of ColoradoAuroraColorado80045-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Northwestern University Feinberg School Of MedicineChicagoIllinois60611-
Loyola University Medical CenterMaywoodIllinois60153-
Indiana University Health Melvin And Bren Simon Cancer CenterIndianapolisIndiana46202-
University Of Kansas Medical CenterKansas CityKansas66160-
The Bunting-Blaustein Cancer Research BuildingBaltimoreMaryland21287-
University Of MarylandBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Beth Israel Deaconess Medical Ctr.BostonMassachusetts02215-
University Of Michigan Medical CenterAnn ArborMichigan48109-
Wayne State UniversityDetroitMichigan48201-
Masonic Cancer Ctr, University Of MinnesotaMinneapolisMinnesota55455-
North Mississippi Hematology And Oncology Associates, LtdTupeloMississippi38801-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering NassauNew YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-
St. Luke'S Roosevelt Hospital CenterNew YorkNew York10019-
Weill Cornell Medical CollegeNew YorkNew York10065-
Blumenthal Cancer CenterCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University Of PennsylvaniaPhiladelphiaPennsylvania19104-
Medical University Of South CarolinaCharlestonSouth Carolina29425-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Vanderbilt-Ingram Cancer CtrNashvilleTennessee37232-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-
Wheaton Franciscan Health CareWauwatosaWisconsin53226-

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