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NCT02231749

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1096

Start Date

2014-10-16

Completion Date

2025-03-21

Last Updated

2026-05-27

Healthy Volunteers

Conditions

Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma

Interventions

BIOLOGICAL

Nivolumab

BIOLOGICAL

Ipilimumab

DRUG

Sunitinib

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC * No prior systemic therapy for RCC with the following exception: 1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy * Karnofsky Performance Status (KPS) of at least 70% * Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Tumor tissue \[formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition\] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration \[FNA\] and bone metastases samples are not acceptable for submission) Exclusion Criteria: * Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization * Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab) * Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll * Any condition requiring systemic treatment with corticosteroids (\>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \>10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease

Locations (189)

Local Institution - 0006

Duarte, California, United States

Local Institution - 0057

La Jolla, California, United States

Local Institution - 0044

Los Angeles, California, United States

Local Institution - 0035

Los Angeles, California, United States

Local Institution - 0067

Stanford, California, United States

Local Institution - 0138

New Haven, Connecticut, United States

Local Institution - 0034

Washington D.C., District of Columbia, United States

Local Institution - 0049

Tampa, Florida, United States

Local Institution - 0068

Atlanta, Georgia, United States

Local Institution - 0038

Indianapolis, Indiana, United States

Local Institution - 0042

Iowa City, Iowa, United States

Local Institution - 0163

Fairway, Kansas, United States

Local Institution - 0048

Baltimore, Maryland, United States

Local Institution - 0004

Baltimore, Maryland, United States

Local Institution - 0135

Boston, Massachusetts, United States

Local Institution - 0110

Boston, Massachusetts, United States

Local Institution - 0161

Boston, Massachusetts, United States

Local Institution - 0173

Boston, Massachusetts, United States

Local Institution - 0046

Ann Arbor, Michigan, United States

Local Institution - 0043

Detroit, Michigan, United States

Local Institution - 0036

Buffalo, New York, United States

Local Institution - 0001

New York, New York, United States

Local Institution - 0008

Charlotte, North Carolina, United States

Local Institution - 0045

Durham, North Carolina, United States

Local Institution - 0007

Cleveland, Ohio, United States

Local Institution - 0164

Columbus, Ohio, United States

Local Institution - 0039

Portland, Oregon, United States

Local Institution - 0054

Allentown, Pennsylvania, United States

Local Institution - 0005

Philadelphia, Pennsylvania, United States

Local Institution - 0031

Pittsburgh, Pennsylvania, United States

Local Institution - 0055

Charleston, South Carolina, United States

Local Institution - 0159

Chattanooga, Tennessee, United States

Local Institution - 0066

Nashville, Tennessee, United States

Local Institution - 0056

Dallas, Texas, United States

Local Institution - 0032

Dallas, Texas, United States

Local Institution - 0003

Houston, Texas, United States

Local Institution - 0041

Seattle, Washington, United States

Local Institution - 0099

Berazategui, Buenos Aires, Argentina

Local Institution - 0098

Capital Federal, Buenos Aires, Argentina

Local Institution - 0139

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0095

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0096

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0097

CABA, Argentina

Local Institution - 0100

Córdoba, Argentina

Local Institution - 0073

Kogarah, New South Wales, Australia

Local Institution - 0070

Westmead, New South Wales, Australia

Local Institution - 0076

Herston, Queensland, Australia

Local Institution - 0075

Southport, Queensland, Australia

Local Institution - 0140

Elizabeth Vale, South Australia, Australia

Local Institution - 0072

Box Hill, Victoria, Australia

Local Institution - 0071

Clayton, Victoria, Australia

Local Institution - 0104

Nedlands, Western Australia, Australia

Local Institution - 0074

Murdoch, Australia

Local Institution - 0108

Linz, Austria

Local Institution - 0109

Vienna, Austria

Local Institution - 0107

Wels, Austria

Local Institution - 0020

Ghent, Belgium

Local Institution - 0019

Leuven, Belgium

Local Institution - 0152

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0150

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0151

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0153

São Paulo, São Paulo, Brazil

Local Institution - 0157

Rio de Janeiro, Brazil

Local Institution - 0155

São Paulo, Brazil

Local Institution - 0156

São Paulo, Brazil

Local Institution - 0149

Calgary, Alberta, Canada

Local Institution - 0133

Edmonton, Alberta, Canada

Local Institution - 0182

Kelowna, British Columbia, Canada

Local Institution - 0128

Vancouver, British Columbia, Canada

Local Institution - 0131

Moncton, New Brunswick, Canada

Local Institution - 0172

Toronto, Ontario, Canada

Local Institution - 0148

Toronto, Ontario, Canada

Local Institution - 0132

Montreal, Quebec, Canada

Local Institution - 0101

Santiago, Santiago Metropolitan, Chile

Local Institution - 0102

Santiago, Santiago Metropolitan, Chile

Local Institution - 0144

Santiago, Santiago Metropolitan, Chile

Local Institution - 0103

Viña del Mar, Chile

Local Institution - 0080

Bogotá, Colombia

Local Institution - 0162

Medellín, Colombia

Local Institution - 0081

Medellín, Colombia

Local Institution - 0050

Liberec, Liberec Region, Czechia

Local Institution - 0053

Brno, Czechia

Local Institution - 0051

Hradec Králové, Czechia

Local Institution - 0052

Olomouc, Czechia

Local Institution - 0136

Aarhus N, Central Jutland, Denmark

Local Institution - 0158

Herlev, Denmark

Local Institution - 0137

Odense, Denmark

Local Institution - 0027

Helsinki, Uusimaa, Finland

Local Institution - 0028

Tampere, Finland

Local Institution - 0170

Besançon, France

Local Institution - 0062

Bordeaux, France

Local Institution - 0169

La Roche-sur-Yon, France

Local Institution - 0060

Marseille, France

Local Institution - 0063

Saint-Herblain, France

Local Institution - 0065

Strasbourg, France

Local Institution - 0059

Toulouse, France

Local Institution - 0058

Villejuif, France

Local Institution - 0061

Paris, Île-de-France Region, France

Local Institution - 0125

Aachen, Germany

Local Institution - 0126

Erlangen, Germany

And 89 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (189)