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

NCT ID: NCT02231749

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-16
• Study Completion Date: 2025-03-21

Brief 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.

Conditions

Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Ipilimumab

Intervention Type: BIOLOGICAL

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

Group Type: ACTIVE_COMPARATOR

Nivolumab

Intervention Type: BIOLOGICAL

Ipilimumab

Intervention Type: BIOLOGICAL

Sunitinib

Intervention Type: DRUG

Interventions

Nivolumab

Intervention Type: BIOLOGICAL

Ipilimumab

Intervention Type: BIOLOGICAL

Sunitinib

Intervention Type: DRUG

Other Intervention Names

BMS-936558; Opdivo; Yervoy; Sutent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0006

Duarte, California, United States

Local Institution - 0057

La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Stanford, California, United States

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New Haven, Connecticut, United States

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

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Fairway, Kansas, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Buffalo, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Seattle, Washington, United States

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Berazategui, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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CABA, , Argentina

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Córdoba, , Argentina

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Kogarah, New South Wales, Australia

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Westmead, New South Wales, Australia

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Herston, Queensland, Australia

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Southport, Queensland, Australia

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Elizabeth Vale, South Australia, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Nedlands, Western Australia, Australia

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Murdoch, , Australia

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Linz, , Austria

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Vienna, , Austria

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Wels, , Austria

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Ghent, , Belgium

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Leuven, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Viña del Mar, , Chile

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Bogotá, , Colombia

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Medellín, , Colombia

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Medellín, , Colombia

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Liberec, Liberecký kraj, Czechia

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Brno, , Czechia

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Aarhus N, Central Jutland, Denmark

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Herlev, , Denmark

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Odense, , Denmark

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Helsinki, Uusimaa, Finland

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Tampere, , Finland

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Besançon, , France

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Bordeaux, , France

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La Roche-sur-Yon, , France

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Marseille, , France

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Saint-Herblain, , France

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Strasbourg, , France

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Toulouse, , France

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Villejuif, , France

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Paris, Île-de-France Region, France

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Aachen, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Homburg, , Germany

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Jena, , Germany

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Magdeburg, , Germany

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München, , Germany

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Münster, , Germany

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Ulm, , Germany

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Gyula, Bekes County, Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Pécs, , Hungary

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Wilton, CORK, Ireland

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Dublin, Dublin, Ireland

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Dublin, Dublin, Ireland

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Dublin, , Ireland

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Haifa, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Ẕerifin, , Israel

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Arezzo, , Italy

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Meldola (fc), , Italy

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Pavia, , Italy

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Roma, , Italy

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Akita, Akita, Japan

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Hirosaki, Aomori, Japan

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Chiba, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Sapporo, Hokai-do, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Tsukuba, Ibaraki, Japan

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Morioka, Iwate, Japan

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Yokohama, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Niigata, Niigata, Japan

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Okayama, Okayama-ken, Japan

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Osakasayamashi, Osaka, Japan

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Suita-shi, Osaka, Japan

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Hamamatsu, Shizuoka, Japan

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Tokushima, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Shinjuku-Ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Tokyo, , Japan

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Yamagata, , Japan

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Querétaro City, Querétaro, Mexico

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Oaxaca City, , Mexico

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Amsterdam, North Holland, Netherlands

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Groningen, , Netherlands

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Nijmegen, , Netherlands

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Krakow, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Oviedo, , Spain

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Seville, , Spain

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Stockholm, , Sweden

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Ankara, , Turkey (Türkiye)

Local Institution - 0114

Antalya, , Turkey (Türkiye)

Local Institution - 0122

Istanbul, , Turkey (Türkiye)

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London, Greater London, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

Local Institution - 0077

London, , United Kingdom

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Manchester, , United Kingdom

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Northwood, , United Kingdom

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Swansea, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; Colombia; Czechia; Denmark; Finland; France; Germany; Hungary; Ireland; Israel; Italy; Japan; Mexico; Netherlands; Poland; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); United Kingdom

References

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Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

2014-001750-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-214

Identifier Type: -

Identifier Source: org_study_id