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

NCT02231749 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-2142014-001750-42
• Study Type: interventional
• Target: 1,096
• Locations: 27 countries
• Sites: 186

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

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1

  ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)

• Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

  OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.

  From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)

• Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

  PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.

  From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)

Secondary Outcomes (3)

• Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1

  From the date of randomization until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to approximately 125 months and 6 days)

• Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

  From the date of randomization to the date of death (assessed up to approximately 125 months and 6 days)

• Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

  From the date of randomization to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to approximately 125 months and 6 days)

Study Arms (2)

Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

EXPERIMENTAL

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

Biological: Nivolumab; Biological: Ipilimumab

Arm B: Sunitinib 50 mg

ACTIVE COMPARATOR

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

Biological: Nivolumab; Biological: Ipilimumab; Drug: Sunitinib

Interventions

Nivolumab BIOLOGICAL

Also known as: BMS-936558, Opdivo

Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg; Arm B: Sunitinib 50 mg

Ipilimumab BIOLOGICAL

Also known as: Yervoy

Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg; Arm B: Sunitinib 50 mg

Sunitinib DRUG

Also known as: Sutent

Arm B: Sunitinib 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co., Ltd.: collaborator

Study Sites (189)

Local Institution - 0006

Duarte, California, 91010, United States

Location

Local Institution - 0057

La Jolla, California, 92093-0698, United States

Location

Local Institution - 0044

Los Angeles, California, 90033, United States

Location

Local Institution - 0035

Los Angeles, California, 90048, United States

Location

Local Institution - 0067

Stanford, California, 94305, United States

Location

Local Institution - 0138

New Haven, Connecticut, 06520, United States

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Local Institution - 0034

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0049

Tampa, Florida, 33612, United States

Location

Local Institution - 0068

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0038

Indianapolis, Indiana, 46202, United States

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Local Institution - 0042

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0163

Fairway, Kansas, 66205, United States

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Local Institution - 0048

Baltimore, Maryland, 21201, United States

Location

Local Institution - 0004

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0135

Boston, Massachusetts, 02111, United States

Location

Local Institution - 0110

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0161

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0173

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0046

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0043

Detroit, Michigan, 48201, United States

Location

Local Institution - 0036

Buffalo, New York, 14263, United States

Location

Local Institution - 0001

New York, New York, 10065, United States

Location

Local Institution - 0008

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0045

Durham, North Carolina, 27710, United States

Location

Local Institution - 0007

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0164

Columbus, Ohio, 43210, United States

Location

Local Institution - 0039

Portland, Oregon, 97239, United States

Location

Local Institution - 0054

Allentown, Pennsylvania, 18105, United States

Location

Local Institution - 0005

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution - 0031

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0055

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0159

Chattanooga, Tennessee, 37403, United States

Location

Local Institution - 0066

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0056

Dallas, Texas, 75246, United States

Location

Local Institution - 0032

Dallas, Texas, 75390-8852, United States

Location

Local Institution - 0003

Houston, Texas, 77030-4009, United States

Location

Local Institution - 0041

Seattle, Washington, 98109, United States

Location

Local Institution - 0099

Berazategui, Buenos Aires, 1880, Argentina

Location

Local Institution - 0098

Capital Federal, Buenos Aires, 1431, Argentina

Location

Local Institution - 0139

Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181, Argentina

Location

Local Institution - 0095

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0096

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0097

CABA, 1426, Argentina

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Local Institution - 0100

Córdoba, 5000, Argentina

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Local Institution - 0073

Kogarah, New South Wales, 2217, Australia

Location

Local Institution - 0070

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0076

Herston, Queensland, 4029, Australia

Location

Local Institution - 0075

Southport, Queensland, 4215, Australia

Location

Local Institution - 0140

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0072

Box Hill, Victoria, 3128, Australia

Location

Local Institution - 0071

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0104

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0074

Murdoch, 6150, Australia

Location

Local Institution - 0108

Linz, 4020, Austria

Location

Local Institution - 0109

Vienna, 1090, Austria

Location

Local Institution - 0107

Wels, 4600, Austria

Location

Local Institution - 0020

Ghent, 9000, Belgium

Location

Local Institution - 0019

Leuven, 3000, Belgium

Location

Local Institution - 0152

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0150

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Local Institution - 0151

Porto Alegre, Rio Grande do Sul, 91610-000, Brazil

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Local Institution - 0153

São Paulo, São Paulo, 01321-001, Brazil

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Local Institution - 0157

Rio de Janeiro, 20793-080, Brazil

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Local Institution - 0155

São Paulo, 01406-100, Brazil

Location

Local Institution - 0156

São Paulo, 01509-010, Brazil

Location

Local Institution - 0149

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 0133

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0182

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Local Institution - 0128

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0131

Moncton, New Brunswick, E1C 8X3, Canada

Location

Local Institution - 0172

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 0148

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0132

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0101

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0102

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0144

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0103

Viña del Mar, 254 0364, Chile

Location

Local Institution - 0080

Bogotá, 0, Colombia

Location

Local Institution - 0162

Medellín, 0, Colombia

Location

Local Institution - 0081

Medellín, MEDELLIN, Colombia

Location

Local Institution - 0050

Liberec, Liberec Region, 460 63, Czechia

Location

Local Institution - 0053

Brno, 656 53, Czechia

Location

Local Institution - 0051

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0052

Olomouc, 779 00, Czechia

Location

Local Institution - 0136

Aarhus N, Central Jutland, 8200, Denmark

Location

Local Institution - 0158

Herlev, 2730, Denmark

Location

Local Institution - 0137

Odense, 5000, Denmark

Location

Local Institution - 0027

Helsinki, Uusimaa, 00290, Finland

Location

Local Institution - 0028

Tampere, 33521, Finland

Location

Local Institution - 0170

Besançon, 25030, France

Location

Local Institution - 0062

Bordeaux, 33075, France

Location

Local Institution - 0169

La Roche-sur-Yon, 85925, France

Location

Local Institution - 0060

Marseille, 13273, France

Location

Local Institution - 0063

Saint-Herblain, 44805, France

Location

Local Institution - 0065

Strasbourg, 67091, France

Location

Local Institution - 0059

Toulouse, 31059, France

Location

Local Institution - 0058

Villejuif, 94805, France

Location

Local Institution - 0061

Paris, Île-de-France Region, 75015, France

Location

Local Institution - 0125

Aachen, 52074, Germany

Location

Local Institution - 0126

Erlangen, 91054, Germany

Location

Local Institution - 0141

Frankfurt, 60590, Germany

Location

Local Institution - 0147

Hamburg, 20246, Germany

Location

Local Institution - 0142

Hanover, 30625, Germany

Location

Local Institution - 0123

Heidelberg, 69126, Germany

Location

Local Institution - 0127

Homburg, 66424, Germany

Location

Local Institution - 0129

Jena, 07747, Germany

Location

Local Institution - 0143

Magdeburg, 39120, Germany

Location

Local Institution - 0124

München, 81675, Germany

Location

Local Institution - 0146

Münster, 48149, Germany

Location

Local Institution - 0130

Ulm, 89075, Germany

Location

Local Institution - 0184

Gyula, Bekes County, 5700, Hungary

Location

Local Institution - 0083

Budapest, 1122, Hungary

Location

Local Institution - 0082

Debrecen, 4032, Hungary

Location

Local Institution - 0084

Pécs, 7624, Hungary

Location

Local Institution - 0015

Wilton, CORK, 0, Ireland

Location

Local Institution - 0017

Dublin, Dublin, 0, Ireland

Location

Local Institution - 0018

Dublin, Dublin, 0, Ireland

Location

Local Institution - 0016

Dublin, 24, Ireland

Location

Local Institution - 0120

Haifa, 31096, Israel

Location

Local Institution - 0117

Kfar Saba, 44281, Israel

Location

Local Institution - 0121

Petah Tikva, 49100, Israel

Location

Local Institution - 0118

Ramat Gan, 52621, Israel

Location

Local Institution - 0119

Ẕerifin, 70300, Israel

Location

Local Institution - 0022

Arezzo, 52100, Italy

Location

Local Institution - 0024

Meldola (fc), 47014, Italy

Location

Local Institution - 0023

Milan, 20133, Italy

Location

Local Institution - 0064

Naples, 80131, Italy

Location

Local Institution - 0079

Padova, 35128, Italy

Location

Local Institution - 0025

Pavia, 27100, Italy

Location

Local Institution - 0026

Roma, 00149, Italy

Location

Local Institution - 0192

Akita, Akita, 010-8542, Japan

Location

Local Institution - 0209

Hirosaki, Aomori, 036-8563, Japan

Location

Local Institution - 0187

Chiba, Chiba, 260-8717, Japan

Location

Local Institution - 0196

Fukuoka, Fukuoka, 8128582, Japan

Location

Local Institution - 0188

Sapporo, Hokai-do, 060-8543, Japan

Location

Local Institution - 0183

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution - 0206

Kobe, Hyōgo, 6500017, Japan

Location

Local Institution - 0205

Tsukuba, Ibaraki, 3058576, Japan

Location

Local Institution - 0200

Morioka, Iwate, 0208505, Japan

Location

Local Institution - 0186

Yokohama, Kanagawa, 2360004, Japan

Location

Local Institution - 0189

Kumamoto, Kumamoto, 8608556, Japan

Location

Local Institution - 0191

Kyoto, Kyoto, 6028566, Japan

Location

Local Institution - 0199

Niigata, Niigata, 9518520, Japan

Location

Local Institution - 0204

Okayama, Okayama-ken, 7008558, Japan

Location

Local Institution - 0190

Osakasayamashi, Osaka, 5898511, Japan

Location

Local Institution - 0201

Suita-shi, Osaka, 565-0871, Japan

Location

Local Institution - 0208

Hamamatsu, Shizuoka, 4313192, Japan

Location

Local Institution - 0194

Tokushima, Tokushima, 770-8503, Japan

Location

Local Institution - 0202

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Local Institution - 0197

Bunkyo-ku, Tokyo, 1138431, Japan

Location

Local Institution - 0195

Bunkyo-ku, Tokyo, 1138655, Japan

Location

Local Institution - 0207

Koto-ku, Tokyo, 1358550, Japan

Location

Local Institution - 0185

Shinjuku-Ku, Tokyo, 1608582, Japan

Location

Local Institution - 0193

Shinjuku-ku, Tokyo, 1628666, Japan

Location

Local Institution - 0198

Tokyo, 113-8519, Japan

Location

Local Institution - 0203

Yamagata, 9909585, Japan

Location

Local Institution - 0168

Mexico City, Mexico City, 14050, Mexico

Location

Local Institution - 0171

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0175

Querétaro City, Querétaro, 76090, Mexico

Location

Local Institution - 0167

Oaxaca City, 68000, Mexico

Location

Local Institution - 0029

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Local Institution - 0040

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0030

Nijmegen, 6525 GA, Netherlands

Location

Local Institution - 0093

Krakow, 31-115, Poland

Location

Local Institution - 0112

Poznan, 60-569, Poland

Location

Local Institution - 0106

Wroclaw, 50-556, Poland

Location

Local Institution - 0178

Seoul, 03080, South Korea

Location

Local Institution - 0177

Seoul, 05505, South Korea

Location

Local Institution - 0176

Seoul, 120-752, South Korea

Location

Local Institution - 0089

Barcelona, 08025, Spain

Location

Local Institution - 0088

Barcelona, 08035, Spain

Location

Local Institution - 0086

Madrid, 28034, Spain

Location

Local Institution - 0085

Madrid, 28040, Spain

Location

Local Institution - 0087

Madrid, 28041, Spain

Location

Local Institution - 0111

Oviedo, 33011, Spain

Location

Local Institution - 0090

Seville, 41013, Spain

Location

Local Institution - 0134

Stockholm, 171 76, Sweden

Location

Local Institution - 0179

Taipei, 100, Taiwan

Location

Local Institution - 0180

Taipei, 112, Taiwan

Location

Local Institution - 0181

Taoyuan, 333, Taiwan

Location

Local Institution - 0115

Ankara, 06230, Turkey (Türkiye)

Location

Local Institution - 0114

Antalya, 07070, Turkey (Türkiye)

Location

Local Institution - 0122

Istanbul, 34890, Turkey (Türkiye)

Location

Local Institution - 0010

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0009

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Local Institution - 0077

London, EC1A 7BE, United Kingdom

Location

Local Institution - 0021

Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0011

Northwood, HA6 2RN, United Kingdom

Location

Local Institution - 0012

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (14)

• Mantia CM, Jegede OA, Plimack ER, Powles T, Motzer RJ, Tannir NM, Lee CH, Tomita Y, Voss MH, Choueiri TK, Rini BI, Hammers HJ, Escudier B, Albiges L, Rosenblatt L, Atkins MB, Regan MM, McDermott DF. Treatment-free survival and partitioned survival analysis of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib: 5-year update of CheckMate 214. J Immunother Cancer. 2024 Jul 25;12(7):e009495. doi: 10.1136/jitc-2024-009495.

  PMID: 39060019 DERIVED

• Cella D, Choueiri TK, Hamilton M, Blum SI, Ivanescu C, Karu K, Ejzykowicz F, Motzer RJ. The Relationship Between Health-Related Quality of Life and Overall Survival in Patients With Advanced Renal Cell Carcinoma in CheckMate 214. Oncologist. 2024 Jun 3;29(6):511-518. doi: 10.1093/oncolo/oyae003.

  PMID: 38280218 DERIVED

• Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

  PMID: 37146227 DERIVED

• Rini BI, Signoretti S, Choueiri TK, McDermott DF, Motzer RJ, George S, Powles T, Donskov F, Tykodi SS, Pal SK, Gupta S, Lee CW, Jiang R, Tannir NM. Long-term outcomes with nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma. J Immunother Cancer. 2022 Dec;10(12):e005445. doi: 10.1136/jitc-2022-005445.

  PMID: 36549781 DERIVED

• Motzer RJ, McDermott DF, Escudier B, Burotto M, Choueiri TK, Hammers HJ, Barthelemy P, Plimack ER, Porta C, George S, Powles T, Donskov F, Gurney H, Kollmannsberger CK, Grimm MO, Barrios C, Tomita Y, Castellano D, Grunwald V, Rini BI, McHenry MB, Lee CW, McCarthy J, Ejzykowicz F, Tannir NM. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022 Jun 1;128(11):2085-2097. doi: 10.1002/cncr.34180. Epub 2022 Apr 5.

  PMID: 35383908 DERIVED

• Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5. No abstract available.

  PMID: 35383907 DERIVED

• Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Leung D, Saggi SS, Lee CW, McHenry MB, Motzer RJ. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial. Eur Urol. 2022 Mar;81(3):266-271. doi: 10.1016/j.eururo.2021.10.001. Epub 2021 Nov 5.

  PMID: 34750035 DERIVED

• Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

  PMID: 33246931 DERIVED

• Motzer RJ, Escudier B, McDermott DF, Aren Frontera O, Melichar B, Powles T, Donskov F, Plimack ER, Barthelemy P, Hammers HJ, George S, Grunwald V, Porta C, Neiman V, Ravaud A, Choueiri TK, Rini BI, Salman P, Kollmannsberger CK, Tykodi SS, Grimm MO, Gurney H, Leibowitz-Amit R, Geertsen PF, Amin A, Tomita Y, McHenry MB, Saggi SS, Tannir NM. Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial. J Immunother Cancer. 2020 Jul;8(2):e000891. doi: 10.1136/jitc-2020-000891.

  PMID: 32661118 DERIVED

• Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

  PMID: 31992108 DERIVED

• Tomita Y, Kondo T, Kimura G, Inoue T, Wakumoto Y, Yao M, Sugiyama T, Oya M, Fujii Y, Obara W, Motzer RJ, Uemura H. Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: analysis of Japanese patients in CheckMate 214 with extended follow-up. Jpn J Clin Oncol. 2020 Jan 24;50(1):12-19. doi: 10.1093/jjco/hyz132.

  PMID: 31633185 DERIVED

• Motzer RJ, Rini BI, McDermott DF, Aren Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthelemy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grunwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16.

  PMID: 31427204 DERIVED

• Cella D, Grunwald V, Escudier B, Hammers HJ, George S, Nathan P, Grimm MO, Rini BI, Doan J, Ivanescu C, Paty J, Mekan S, Motzer RJ. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):297-310. doi: 10.1016/S1470-2045(18)30778-2. Epub 2019 Jan 15.

  PMID: 30658932 DERIVED

• 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.

  PMID: 29562145 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nivolumab; Ipilimumab; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 4, 2014
• Study Start: October 16, 2014
• Primary Completion: June 26, 2017
• Study Completion: March 21, 2025
• Last Updated: May 27, 2026
• Results First Posted: October 16, 2018

Record last verified: 2026-05

Locations

TU (3); US (37); KR (3); JP (26); CZ (4); PL (3); SE (1); CL (4); NL (3); AR (7); DK (3); IL (5); FR (9); IT (7); TW (3); BR (7); AU (9); FI (2); HU (4); IE (4); CA (8); CO (3); ME (4); ES (7); BE (2); GB (6); DE (12)