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.
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
- Conditions the study is for
- Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- What is being tested?
- Nivolumab, Ipilimumab and Sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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
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
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
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
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
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
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
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
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
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
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
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
Ẕerifin, 70300
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
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
Hungary4 sites
Local Institution - 0083
Budapest, 1122
Local Institution - 0082
Debrecen, 4032
Local Institution - 0184
Gyula, Bekes County, 5700
Local Institution - 0084
Pécs, 7624
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
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
Austria3 sites
Local Institution - 0108
Linz, 4020
Local Institution - 0109
Vienna, 1090
Local Institution - 0107
Wels, 4600
Colombia3 sites
Local Institution - 0080
Bogotá, 0
Local Institution - 0162
Medellín, 0
Local Institution - 0081
Medellín, MEDELLIN
Denmark3 sites
Local Institution - 0136
Aarhus N, Central Jutland, 8200
Local Institution - 0158
Herlev, 2730
Local Institution - 0137
Odense, 5000
Netherlands3 sites
Local Institution - 0029
Amsterdam, North Holland, 1066 CX
Local Institution - 0040
Groningen, 9713 GZ
Local Institution - 0030
Nijmegen, 6525 GA
Poland3 sites
Local Institution - 0093
Krakow, 31-115
Local Institution - 0112
Poznan, 60-569
Local Institution - 0106
Wroclaw, 50-556
South Korea3 sites
Local Institution - 0178
Seoul, 03080
Local Institution - 0177
Seoul, 05505
Local Institution - 0176
Seoul, 120-752
Taiwan3 sites
Local Institution - 0179
Taipei, 100
Local Institution - 0180
Taipei, 112
Local Institution - 0181
Taoyuan, 333
Turkey (Türkiye)3 sites
Local Institution - 0115
Ankara, 06230
Local Institution - 0114
Antalya, 07070
Local Institution - 0122
Istanbul, 34890
Belgium2 sites
Local Institution - 0020
Ghent, 9000
Local Institution - 0019
Leuven, 3000
Finland2 sites
Local Institution - 0027
Helsinki, Uusimaa, 00290
Local Institution - 0028
Tampere, 33521
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.
- Being tested
- Nivolumab, Ipilimumab, Sunitinib
- 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.
NivolumabBiological
Also called BMS-936558, Opdivo
IpilimumabBiological
Also called Yervoy
SunitinibDrug
Also called Sutent
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Nivolumab; Biological: Ipilimumab; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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.
- First posted4 Sep 2014 (estimated)
- Study start16 Oct 2014
- Primary completion26 Jun 2017
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 39060019Cella 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 38280218Aldin 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 37146227Rini 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 36549781Motzer 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 35383908Labriola 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 35383907Albiges 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 34750035Albiges 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 33246931Motzer 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.
PubMed 32661118Ambavane 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.
PubMed 31992108Tomita 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.
PubMed 31633185Motzer 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.
PubMed 31427204Cella 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.
PubMed 30658932Motzer 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.
PubMed 29562145