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AzTrials

Advanced Renal Cell CarcinomaPhase 3NCT02231749

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

A Phase 3 study testing Nivolumab, Ipilimumab and Sunitinib in people with Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Bristol-Myers Squibb at 189 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Ipilimumab and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,096 participants
Where
189 sitesin 28 countries
Study dates
16 Oct 2014to 21 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

189 sites in 28 countries.

189 sites in 28 countries

United States37 sites

  • Local Institution - 0054

    Allentown, Pennsylvania, 18105

  • Local Institution - 0046

    Ann Arbor, Michigan, 48109

  • Local Institution - 0068

    Atlanta, Georgia, 30322

  • Local Institution - 0048

    Baltimore, Maryland, 21201

  • Local Institution - 0004

    Baltimore, Maryland, 21287

  • Local Institution - 0135

    Boston, Massachusetts, 02111

  • Local Institution - 0110

    Boston, Massachusetts, 02215

  • Local Institution - 0161

    Boston, Massachusetts, 02215

  • Local Institution - 0173

    Boston, Massachusetts, 02215

  • Local Institution - 0036

    Buffalo, New York, 14263

  • Local Institution - 0055

    Charleston, South Carolina, 29425

  • Local Institution - 0008

    Charlotte, North Carolina, 28204

  • Local Institution - 0159

    Chattanooga, Tennessee, 37403

  • Local Institution - 0007

    Cleveland, Ohio, 44195

  • Local Institution - 0164

    Columbus, Ohio, 43210

  • Local Institution - 0056

    Dallas, Texas, 75246

  • Local Institution - 0032

    Dallas, Texas, 75390-8852

  • Local Institution - 0043

    Detroit, Michigan, 48201

  • Local Institution - 0006

    Duarte, California, 91010

  • Local Institution - 0045

    Durham, North Carolina, 27710

  • Local Institution - 0163

    Fairway, Kansas, 66205

  • Local Institution - 0003

    Houston, Texas, 77030-4009

  • Local Institution - 0038

    Indianapolis, Indiana, 46202

  • Local Institution - 0042

    Iowa City, Iowa, 52242

  • Local Institution - 0057

    La Jolla, California, 92093-0698

  • Local Institution - 0044

    Los Angeles, California, 90033

  • Local Institution - 0035

    Los Angeles, California, 90048

  • Local Institution - 0066

    Nashville, Tennessee, 37203

  • Local Institution - 0138

    New Haven, Connecticut, 06520

  • Local Institution - 0001

    New York, New York, 10065

  • Local Institution - 0005

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 0031

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0039

    Portland, Oregon, 97239

  • Local Institution - 0041

    Seattle, Washington, 98109

  • Local Institution - 0067

    Stanford, California, 94305

  • Local Institution - 0049

    Tampa, Florida, 33612

  • Local Institution - 0034

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan26 sites

  • Local Institution - 0192

    Akita, Akita, 010-8542

  • Local Institution - 0202

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 0197

    Bunkyo-ku, Tokyo, 1138431

  • Local Institution - 0195

    Bunkyo-ku, Tokyo, 1138655

  • Local Institution - 0187

    Chiba, Chiba, 260-8717

  • Local Institution - 0196

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0208

    Hamamatsu, Shizuoka, 4313192

  • Local Institution - 0209

    Hirosaki, Aomori, 036-8563

  • Local Institution - 0206

    Kobe, Hyōgo, 6500017

  • Local Institution - 0207

    Koto-ku, Tokyo, 1358550

  • Local Institution - 0189

    Kumamoto, Kumamoto, 8608556

  • Local Institution - 0191

    Kyoto, Kyoto, 6028566

  • Local Institution - 0200

    Morioka, Iwate, 0208505

  • Local Institution - 0199

    Niigata, Niigata, 9518520

  • Local Institution - 0204

    Okayama, Okayama-ken, 7008558

  • Local Institution - 0190

    Osakasayamashi, Osaka, 5898511

  • Local Institution - 0188

    Sapporo, Hokai-do, 060-8543

  • Local Institution - 0183

    Sapporo, Hokkaido, 060-8648

  • Local Institution - 0193

    Shinjuku-ku, Tokyo, 1628666

  • Local Institution - 0185

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution - 0201

    Suita-shi, Osaka, 565-0871

  • Local Institution - 0194

    Tokushima, Tokushima, 770-8503

  • Local Institution - 0198

    Tokyo, 113-8519

  • Local Institution - 0205

    Tsukuba, Ibaraki, 3058576

  • Local Institution - 0203

    Yamagata, 9909585

  • Local Institution - 0186

    Yokohama, Kanagawa, 2360004

Other trials in Japan

Germany12 sites

  • Local Institution - 0125

    Aachen, 52074

  • Local Institution - 0126

    Erlangen, 91054

  • Local Institution - 0141

    Frankfurt, 60590

  • Local Institution - 0147

    Hamburg, 20246

  • Local Institution - 0142

    Hanover, 30625

  • Local Institution - 0123

    Heidelberg, 69126

  • Local Institution - 0127

    Homburg, 66424

  • Local Institution - 0129

    Jena, 07747

  • Local Institution - 0143

    Magdeburg, 39120

  • Local Institution - 0124

    München, 81675

  • Local Institution - 0146

    Münster, 48149

  • Local Institution - 0130

    Ulm, 89075

Other trials in Germany

Australia9 sites

  • Local Institution - 0072

    Box Hill, Victoria, 3128

  • Local Institution - 0071

    Clayton, Victoria, 3168

  • Local Institution - 0140

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0076

    Herston, Queensland, 4029

  • Local Institution - 0073

    Kogarah, New South Wales, 2217

  • Local Institution - 0074

    Murdoch, 6150

  • Local Institution - 0104

    Nedlands, Western Australia, 6009

  • Local Institution - 0075

    Southport, Queensland, 4215

  • Local Institution - 0070

    Westmead, New South Wales, 2145

Other trials in Australia

France9 sites

  • Local Institution - 0170

    Besançon, 25030

  • Local Institution - 0062

    Bordeaux, 33075

  • Local Institution - 0169

    La Roche-sur-Yon, 85925

  • Local Institution - 0060

    Marseille, 13273

  • Local Institution - 0061

    Paris, Île-de-France Region, 75015

  • Local Institution - 0063

    Saint-Herblain, 44805

  • Local Institution - 0065

    Strasbourg, 67091

  • Local Institution - 0059

    Toulouse, 31059

  • Local Institution - 0058

    Villejuif, 94805

Other trials in France

Canada8 sites

  • Local Institution - 0149

    Calgary, Alberta, T2N 4N2

  • Local Institution - 0133

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0182

    Kelowna, British Columbia, V1Y 5L3

  • Local Institution - 0131

    Moncton, New Brunswick, E1C 8X3

  • Local Institution - 0132

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0172

    Toronto, Ontario, M4N 3M5

  • Local Institution - 0148

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0128

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Argentina7 sites

  • Local Institution - 0099

    Berazategui, Buenos Aires, 1880

  • Local Institution - 0097

    CABA, 1426

  • Local Institution - 0098

    Capital Federal, Buenos Aires, 1431

  • Local Institution - 0139

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181

  • Local Institution - 0100

    Córdoba, 5000

  • Local Institution - 0095

    San Miguel de Tucumán, Tucumán Province, 4000

  • Local Institution - 0096

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil7 sites

  • Local Institution - 0152

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0150

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution - 0151

    Porto Alegre, Rio Grande do Sul, 91610-000

  • Local Institution - 0157

    Rio de Janeiro, 20793-080

  • Local Institution - 0153

    São Paulo, São Paulo, 01321-001

  • Local Institution - 0155

    São Paulo, 01406-100

  • Local Institution - 0156

    São Paulo, 01509-010

Other trials in Brazil

Italy7 sites

  • Local Institution - 0022

    Arezzo, 52100

  • Local Institution - 0024

    Meldola (fc), 47014

  • Local Institution - 0023

    Milan, 20133

  • Local Institution - 0064

    Naples, 80131

  • Local Institution - 0079

    Padova, 35128

  • Local Institution - 0025

    Pavia, 27100

  • Local Institution - 0026

    Roma, 00149

Other trials in Italy

Spain7 sites

  • Local Institution - 0089

    Barcelona, 08025

  • Local Institution - 0088

    Barcelona, 08035

  • Local Institution - 0086

    Madrid, 28034

  • Local Institution - 0085

    Madrid, 28040

  • Local Institution - 0087

    Madrid, 28041

  • Local Institution - 0111

    Oviedo, 33011

  • Local Institution - 0090

    Seville, 41013

Other trials in Spain

United Kingdom6 sites

  • Local Institution - 0009

    Glasgow, Lanarkshire, G12 0YN

  • Local Institution - 0010

    London, Greater London, SW3 6JJ

  • Local Institution - 0077

    London, EC1A 7BE

  • Local Institution - 0021

    Manchester, M20 4BX

  • Local Institution - 0011

    Northwood, HA6 2RN

  • Local Institution - 0012

    Swansea, SA2 8QA

Other trials in United Kingdom

Israel5 sites

  • Local Institution - 0120

    Haifa, 31096

  • Local Institution - 0117

    Kfar Saba, 44281

  • Local Institution - 0121

    Petah Tikva, 49100

  • Local Institution - 0118

    Ramat Gan, 52621

  • Local Institution - 0119

    Tsrifin, 70300

Other trials in Israel

Chile4 sites

  • Local Institution - 0101

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0102

    Santiago, Santiago Metropolitan

  • Local Institution - 0144

    Santiago, Santiago Metropolitan

  • Local Institution - 0103

    Viña del Mar, 254 0364

Other trials in Chile

Czechia4 sites

  • Local Institution - 0053

    Brno, 656 53

  • Local Institution - 0051

    Hradec Králové, 500 05

  • Local Institution - 0050

    Liberec, Liberec Region, 460 63

  • Local Institution - 0052

    Olomouc, 779 00

Other trials in Czechia

Hungary4 sites

  • Local Institution - 0083

    Budapest, 1122

  • Local Institution - 0082

    Debrecen, 4032

  • Local Institution - 0184

    Gyula, Bekes County, 5700

  • Local Institution - 0084

    Pécs, 7624

Other trials in Hungary

Ireland4 sites

  • Local Institution - 0017

    Dublin, Dublin, 0

  • Local Institution - 0018

    Dublin, Dublin, 0

  • Local Institution - 0016

    Dublin, 24

  • Local Institution - 0015

    Wilton, CORK, 0

Other trials in Ireland

Mexico4 sites

  • Local Institution - 0168

    Mexico City, Mexico City, 14050

  • Local Institution - 0171

    Monterrey, Nuevo León, 64460

  • Local Institution - 0167

    Oaxaca City, 68000

  • Local Institution - 0175

    Querétaro City, Querétaro, 76090

Other trials in Mexico

Austria3 sites

  • Local Institution - 0108

    Linz, 4020

  • Local Institution - 0109

    Vienna, 1090

  • Local Institution - 0107

    Wels, 4600

Other trials in Austria

Colombia3 sites

  • Local Institution - 0080

    Bogotá, 0

  • Local Institution - 0162

    Medellín, 0

  • Local Institution - 0081

    Medellín, MEDELLIN

Other trials in Colombia

Denmark3 sites

  • Local Institution - 0136

    Aarhus N, Central Jutland, 8200

  • Local Institution - 0158

    Herlev, 2730

  • Local Institution - 0137

    Odense, 5000

Other trials in Denmark

Netherlands3 sites

  • Local Institution - 0029

    Amsterdam, North Holland, 1066 CX

  • Local Institution - 0040

    Groningen, 9713 GZ

  • Local Institution - 0030

    Nijmegen, 6525 GA

Other trials in Netherlands

Poland3 sites

  • Local Institution - 0093

    Krakow, 31-115

  • Local Institution - 0112

    Poznan, 60-569

  • Local Institution - 0106

    Wroclaw, 50-556

Other trials in Poland

South Korea3 sites

  • Local Institution - 0178

    Seoul, 03080

  • Local Institution - 0177

    Seoul, 05505

  • Local Institution - 0176

    Seoul, 120-752

Other trials in South Korea

Taiwan3 sites

  • Local Institution - 0179

    Taipei, 100

  • Local Institution - 0180

    Taipei, 112

  • Local Institution - 0181

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)3 sites

  • Local Institution - 0115

    Ankara, 06230

  • Local Institution - 0114

    Antalya, 07070

  • Local Institution - 0122

    Istanbul, 34890

Other trials in Turkey (Türkiye)

Belgium2 sites

  • Local Institution - 0020

    Ghent, 9000

  • Local Institution - 0019

    Leuven, 3000

Other trials in Belgium

Finland2 sites

  • Local Institution - 0027

    Helsinki, Uusimaa, 00290

  • Local Institution - 0028

    Tampere, 33521

Other trials in Finland

Sweden1 site

  • Local Institution - 0134

    Stockholm, 171 76

Other trials in Sweden

About this study

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

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.

Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02231749
Study groupRoleWhat they receive
Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgExperimentalNivolumab 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
Receives: Biological: Nivolumab; Biological: Ipilimumab
Arm B: Sunitinib 50 mgActive comparatorSunitinib 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
Receives: Biological: Nivolumab; Biological: Ipilimumab; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

    Measured: 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)

  1. Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per 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 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

    Measured: 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)

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

    Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.

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

  3. Progression-Free Survival (PFS) in Any 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2014 (estimated)
  2. Study start16 Oct 2014
  3. Primary completion26 Jun 2017
  4. Study completion21 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,096 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231749
Sponsor's protocol ID
CA209-214
Other IDs
2014-001750-42, 2014
Status last verified
May 2026
First submitted
1 Sep 2014
Last updated
27 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39060019

  • 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.

    PubMed 38280218

  • 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.

    PubMed 37146227

  • 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.

    PubMed 36549781

  • 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.

    PubMed 35383908

  • 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.

    PubMed 35383907

  • 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.

    PubMed 34750035

  • 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.

    PubMed 33246931

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Sunitinib in people with Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Bristol-Myers Squibb at 189 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Japan, Germany, Australia, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231749, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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