Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Part of paid clinical trials in Duarte, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02231749
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

Key Dates

Start date
Oct 16, 2014
Status verified
May 2026
Primary completion
Jun 26, 2017
Completion
Mar 21, 2025

Study Design

Enrollment
1,096 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
    Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  • Active Comparator: Arm B: Sunitinib 50 mg
    Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks

Primary Outcome Measure

Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1 [ Time Frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) ]

Locations (37)

FacilityCityStateZIPSite coordinators
Local Institution - 0006DuarteCalifornia91010-
Local Institution - 0057La JollaCalifornia92093-0698-
Local Institution - 0035Los AngelesCalifornia90048-
Local Institution - 0044Los AngelesCalifornia90033-
Local Institution - 0067StanfordCalifornia94305-
Local Institution - 0138New HavenConnecticut06520-
Local Institution - 0034Washington D.C.District of Columbia20007-
Local Institution - 0049TampaFlorida33612-
Local Institution - 0068AtlantaGeorgia30322-
Local Institution - 0038IndianapolisIndiana46202-
Local Institution - 0042Iowa CityIowa52242-
Local Institution - 0163FairwayKansas66205-
Local Institution - 0004BaltimoreMaryland21287-
Local Institution - 0048BaltimoreMaryland21201-
Local Institution - 0110BostonMassachusetts02215-
Local Institution - 0135BostonMassachusetts02111-
Local Institution - 0161BostonMassachusetts02215-
Local Institution - 0173BostonMassachusetts02215-
Local Institution - 0046Ann ArborMichigan48109-
Local Institution - 0043DetroitMichigan48201-
Local Institution - 0036BuffaloNew York14263-
Local Institution - 0001New YorkNew York10065-
Local Institution - 0008CharlotteNorth Carolina28204-
Local Institution - 0045DurhamNorth Carolina27710-
Local Institution - 0007ClevelandOhio44195-
Local Institution - 0164ColumbusOhio43210-
Local Institution - 0039PortlandOregon97239-
Local Institution - 0054AllentownPennsylvania18105-
Local Institution - 0005PhiladelphiaPennsylvania19111-
Local Institution - 0031PittsburghPennsylvania15232-
Local Institution - 0055CharlestonSouth Carolina29425-
Local Institution - 0159ChattanoogaTennessee37403-
Local Institution - 0066NashvilleTennessee37203-
Local Institution - 0032DallasTexas75390-8852-
Local Institution - 0056DallasTexas75246-
Local Institution - 0003HoustonTexas77030-4009-
Local Institution - 0041SeattleWashington98109-

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By research site
Local Institution - 0006· Duarte, CALocal Institution - 0057· La Jolla, CALocal Institution - 0035· Los Angeles, CALocal Institution - 0044· Los Angeles, CALocal Institution - 0067· Stanford, CALocal Institution - 0138· New Haven, CT

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