A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
NCT ID: NCT03141177
Last Updated: 2025-06-06
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
701 participants
INTERVENTIONAL
2017-07-23
2026-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Doublet
Nivolumab and Cabozantinib
Nivolumab
Specified dose on specified day
Cabozantinib
Specified dose on specified days
Monotherapy
Sunitinib
Sunitinib
Specified dose on specified days.
Triplet
Nivolumab, Ipilimumab, Cabozantinib
\*Enrollment to the triplet arm was discontinued by protocol amendment
Ipilimumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified day
Cabozantinib
Specified dose on specified days
Sunitinib
Specified dose on specified days.
Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Exclusion Criteria
* Any active, known or suspected autoimmune disease
* Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
* Participants who have received a live/attenuated vaccine within 30 days of first treatment
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0077
Daphne, Alabama, United States
Local Institution - 0044
Goodyear, Arizona, United States
Local Institution - 0132
Tucson, Arizona, United States
Local Institution - 0133
Bakersfield, California, United States
Local Institution - 0093
Los Angeles, California, United States
Local Institution - 0090
Redondo Beach, California, United States
Local Institution - 0088
San Luis Obispo, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Local Institution - 0103
Aurora, Colorado, United States
Local Institution - 0127
Athens, Georgia, United States
Local Institution - 0086
Newnan, Georgia, United States
Local Institution - 0036
Chicago, Illinois, United States
Local Institution - 0042
Zion, Illinois, United States
Local Institution - 0091
Fort Wayne, Indiana, United States
Local Institution - 0087
Wichita, Kansas, United States
Local Institution - 0113
Boston, Massachusetts, United States
Local Institution - 0037
Boston, Massachusetts, United States
Local Institution - 0106
Kansas City, Missouri, United States
Local Institution - 0035
St Louis, Missouri, United States
Local Institution - 0102
Las Vegas, Nevada, United States
Local Institution - 0040
Buffalo, New York, United States
Local Institution - 0017
New York, New York, United States
Local Institution - 0067
Portland, Oregon, United States
Local Institution - 0135
Allentown, Pennsylvania, United States
Local Institution - 0105
Nashville, Tennessee, United States
Local Institution - 0080
Austin, Texas, United States
Local Institution - 0075
Dallas, Texas, United States
Local Institution - 0068
Houston, Texas, United States
Local Institution - 0078
Sherman, Texas, United States
Local Institution - 0131
Norfolk, Virginia, United States
Local Institution - 0046
CABA, Buenos Aires, Argentina
Local Institution - 0048
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Local Institution - 0114
Viedma, Río Negro Province, Argentina
Local Institution - 0138
CABA, , Argentina
Local Institution - 0050
Córdoba, , Argentina
Local Institution - 0049
Córdoba, , Argentina
Local Institution - 0047
San Miguel de Tucumán, , Argentina
Local Institution - 0002
North Ryde, New South Wales, Australia
Local Institution - 0008
Sydney, New South Wales, Australia
Local Institution - 0009
Sydney, New South Wales, Australia
Local Institution - 0073
Westmead, New South Wales, Australia
Local Institution - 0006
Herston, Queensland, Australia
Local Institution - 0001
Southport, Queensland, Australia
Local Institution - 0004
Elizabeth Vale, South Australia, Australia
Local Institution - 0005
Malvern, Victoria, Australia
Local Institution - 0007
Doubleview, Western Australia, Australia
Local Institution - 0129
South Brisbane, , Australia
Local Institution - 0057
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0119
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0056
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0060
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0058
Barretos, São Paulo, Brazil
Local Institution - 0066
Rio de Janeiro, , Brazil
Local Institution - 0074
São Paulo, , Brazil
Local Institution - 0061
São Paulo, , Brazil
Local Institution - 0045
Santiago, Santiago Metropolitan, Chile
Local Institution - 0034
Hradec Králové, , Czechia
Local Institution - 0033
Olomouc, , Czechia
Local Institution - 0013
Aachen, , Germany
Local Institution - 0016
Bonn, , Germany
Local Institution - 0117
Essen, , Germany
Local Institution - 0023
Jena, , Germany
Local Institution - 0010
München, , Germany
Local Institution - 0014
Nuremberg, , Germany
Local Institution - 0011
Tübingen, , Germany
Local Institution - 0082
Athens, , Greece
Local Institution - 0083
Thessaloniki, , Greece
Local Institution - 0072
Haifa, , Israel
Local Institution - 0070
Kfar Saba, , Israel
Local Institution - 0071
Petah Tikva, , Israel
Local Institution - 0069
Ramat Gan, , Israel
Local Institution - 0054
Arezzo, , Italy
Local Institution - 0052
Milan, , Italy
Local Institution - 0055
Napoli, , Italy
Local Institution - 0053
Padua, , Italy
Local Institution - 0051
Pavia, , Italy
Local Institution - 0147
Pavia, , Italy
Local Institution - 0172
Terni, , Italy
Local Institution - 0148
Akita, Akita, Japan
Local Institution - 0156
Hirosaki, Aomori, Japan
Local Institution - 0164
Sapporo, Hokkaido, Japan
Local Institution - 0157
Sapporo, Hokkaido, Japan
Local Institution - 0168
Kobe, Hyōgo, Japan
Local Institution - 0159
Morioka, Iwate, Japan
Local Institution - 0171
Yokohama, Kanagawa, Japan
Local Institution - 0166
Yokohama, Kanagawa, Japan
Local Institution - 0150
Niigata, Niigata, Japan
Local Institution - 0169
Okayama, Okayama-ken, Japan
Local Institution - 0170
Osaka, Osaka, Japan
Local Institution - 0160
Osakasayamashi, Osaka, Japan
Local Institution - 0163
Suita-shi, Osaka, Japan
Local Institution - 0154
Osaka, Osaka-shi, Japan
Local Institution - 0155
Hidaka-shi, Saitama, Japan
Local Institution - 0153
Tokushima, Tokushima, Japan
Local Institution - 0152
Adachi-ku, Tokyo, Japan
Local Institution - 0158
Bunkyo-ku, Tokyo, Japan
Local Institution - 0151
Bunkyo-ku, Tokyo, Japan
Local Institution - 0173
Minato-ku, Tokyo, Japan
Local Institution - 0167
Chiba, , Japan
Local Institution - 0161
Fukuoka, , Japan
Local Institution - 0162
Nagasaki, , Japan
Local Institution - 0149
Tokyo, , Japan
Local Institution - 0165
Yamagata, , Japan
Local Institution - 0108
Zapopan, Jalisco, Mexico
Local Institution - 0062
Mexico City, Mexico City, Mexico
Local Institution - 0116
Mexico City, Mexico City, Mexico
Local Institution - 0115
Tlalpan, Mexico City, Mexico
Local Institution - 0065
Monterrey, Nuevo León, Mexico
Local Institution - 0143
Monterrey, Nuevo León, Mexico
Local Institution - 0064
Monterrey, Nuevo León, Mexico
Local Institution - 0063
Querétaro City, Querétaro, Mexico
Local Institution - 0136
Mérida, Yucatán, Mexico
Local Institution - 0084
Biała Podlaska, , Poland
Local Institution - 0130
Bydgoszcz, , Poland
Local Institution - 0085
Gdansk, , Poland
Local Institution - 0021
Cluj-Napoca, , Romania
Local Institution - 0022
Craiova, , Romania
Local Institution - 0020
Moscow, , Russia
Local Institution - 0099
Saint Petersburg, , Russia
Local Institution - 0125
Barcelona, , Spain
Local Institution - 0121
Madrid, , Spain
Local Institution - 0120
Madrid, , Spain
Local Institution - 0144
Santander, , Spain
Local Institution - 0124
Seville, , Spain
Local Institution - 0123
Valencia, , Spain
Local Institution - 0107
Ankara, , Turkey (Türkiye)
Local Institution - 0139
Ankara, , Turkey (Türkiye)
Local Institution - 0094
Ankara, , Turkey (Türkiye)
Local Institution - 0096
Antalya, , Turkey (Türkiye)
Local Institution - 0097
Denizli, , Turkey (Türkiye)
Local Institution - 0095
Edirne, , Turkey (Türkiye)
Local Institution - 0146
Istanbul, , Turkey (Türkiye)
Local Institution - 0111
London, , United Kingdom
Local Institution - 0109
Manchester, , United Kingdom
Local Institution - 0140
Truro, , United Kingdom
Countries
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References
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Cella D, Motzer RJ, Suarez C, Blum SI, Ejzykowicz F, Hamilton M, Wallace JF, Simsek B, Zhang J, Ivanescu C, Choueiri TK, Apolo AB. Plain language summary of quality of life in CheckMate 9ER: Cabozantinib plus nivolumab in advanced renal cell carcinoma. Future Oncol. 2025 Jan;21(2):181-194. doi: 10.1080/14796694.2024.2415786. Epub 2024 Oct 25.
Powles T, Burotto M, Escudier B, Apolo AB, Bourlon MT, Shah AY, Suarez C, Porta C, Barrios CH, Richardet M, Gurney H, Kessler ER, Tomita Y, Bedke J, George S, Scheffold C, Wang P, Fedorov V, Motzer RJ, Choueiri TK. Nivolumab plus cabozantinib versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended follow-up from the phase III randomised CheckMate 9ER trial. ESMO Open. 2024 May;9(5):102994. doi: 10.1016/j.esmoop.2024.102994. Epub 2024 Apr 20.
Petersohn S, McGregor B, Klijn SL, May JR, Ejzykowicz F, Kurt M, Dyer M, Malcolm B, Branchoux S, Nickel K, George S, Kroep S. Challenges in conducting fractional polynomial and standard parametric network meta-analyses of immune checkpoint inhibitors for first-line advanced renal cell carcinoma. J Comp Eff Res. 2023 Aug;12(8):e230004. doi: 10.57264/cer-2023-0004. Epub 2023 Jul 11.
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.
Tran BD, Li J, Ly N, Faggioni R, Roskos L. Cabozantinib exposure-response analysis for the phase 3 CheckMate 9ER trial of nivolumab plus cabozantinib versus sunitinib in first-line advanced renal cell carcinoma. Cancer Chemother Pharmacol. 2023 Feb;91(2):179-189. doi: 10.1007/s00280-022-04500-9. Epub 2023 Jan 10.
Apolo AB, Powles T, Escudier B, Burotto M, Zhang J, Simsek B, Scheffold C, Motzer RJ, Choueiri TK. Nivolumab plus ipilimumab plus cabozantinib triplet combination for patients with previously untreated advanced renal cell carcinoma: Results from a discontinued arm of the phase III CheckMate 9ER trial. Eur J Cancer. 2022 Dec;177:63-71. doi: 10.1016/j.ejca.2022.09.020. Epub 2022 Oct 4.
Motzer RJ, Powles T, Burotto M, Escudier B, Bourlon MT, Shah AY, Suarez C, Hamzaj A, Porta C, Hocking CM, Kessler ER, Gurney H, Tomita Y, Bedke J, Zhang J, Simsek B, Scheffold C, Apolo AB, Choueiri TK. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):888-898. doi: 10.1016/S1470-2045(22)00290-X. Epub 2022 Jun 7.
Cella D, Motzer RJ, Suarez C, Blum SI, Ejzykowicz F, Hamilton M, Wallace JF, Simsek B, Zhang J, Ivanescu C, Apolo AB, Choueiri TK. Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):292-303. doi: 10.1016/S1470-2045(21)00693-8. Epub 2022 Jan 12.
Hamuro L, Hu Z, Passarell J, Barcomb H, Zhang J, Goldstein S, Bello A, Roy A, Zhu L. Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma. Clin Cancer Res. 2022 Apr 14;28(8):1603-1613. doi: 10.1158/1078-0432.CCR-21-3149.
Choueiri TK, Powles T, Burotto M, Escudier B, Bourlon MT, Zurawski B, Oyervides Juarez VM, Hsieh JJ, Basso U, Shah AY, Suarez C, Hamzaj A, Goh JC, Barrios C, Richardet M, Porta C, Kowalyszyn R, Feregrino JP, Zolnierek J, Pook D, Kessler ER, Tomita Y, Mizuno R, Bedke J, Zhang J, Maurer MA, Simsek B, Ejzykowicz F, Schwab GM, Apolo AB, Motzer RJ; CheckMate 9ER Investigators. Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2021 Mar 4;384(9):829-841. doi: 10.1056/NEJMoa2026982.
Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2017-000759-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-9ER
Identifier Type: -
Identifier Source: org_study_id
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