TriangleNCT03141177 · CITED IN SOURCE DOCUMENTS
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2026-08-24
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression Free Survival (PFS)
Overall Survival (OS)
Objective Response Rate (ORR)
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Serious Adverse Events (SAEs)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Number of Deaths
Number of Participants With Laboratory Abnormalities
Number of Participants With Laboratory Values Grade Shifting From Baseline
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features * 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 CNS metastases * 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 Other protocol defined inclusion/exclusion criteria could apply
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Nivolumab and Cabozantinib
- intervention Names
- Biological: Nivolumab
- Drug: Cabozantinib
- label
- Doublet
- type
- EXPERIMENTAL
- description
- Sunitinib
- intervention Names
- Drug: Sunitinib
- label
- Monotherapy
- type
- ACTIVE_COMPARATOR
- description
- Nivolumab, Ipilimumab, Cabozantinib \*Enrollment to the triplet arm was discontinued by protocol amendment
- intervention Names
- Biological: Ipilimumab
- label
- Triplet
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Doublet
- description
- Specified dose on specified day
- name
- Nivolumab
- other Names
- Opdivo
- BMS-936558
- type
- BIOLOGICAL
- arm Group Labels
- Doublet
- description
- Specified dose on specified days
- name
- Cabozantinib
- other Names
- Cabometyx
- type
- DRUG
- arm Group Labels
- Monotherapy
- description
- Specified dose on specified days.
- name
- Sunitinib
- other Names
- Sutent
- type
- DRUG
- arm Group Labels
- Triplet
- description
- Specified dose on specified days
- name
- Ipilimumab
- other Names
- Yervoy
- BMS-734016
- type
- BIOLOGICAL
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 701
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
- measure
- Progression Free Survival (PFS)
- time Frame
- From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
- secondary Outcomes
- description
- Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
- measure
- Overall Survival (OS)
- time Frame
- From randomization date to death date (Up to 31 months)
- description
- Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
- measure
- Objective Response Rate (ORR)
- time Frame
- Up to 31 Months
- description
- Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
- measure
- Number of Participants Experiencing Adverse Events (AEs)
- time Frame
- From first dose to 100 days following last dose (Up to 32 Months)
- description
- Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
- measure
- Number of Participants Experiencing Serious Adverse Events (SAEs)
- time Frame
- From first to dose to 100 days following last dose (Up to 32 months)
- description
- Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
- measure
- Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
- time Frame
- From first dose to 30 days following last dose (Up to 30 months)
- description
- Number of deaths due to any cause during the specified time frame.
- measure
- Number of Deaths
- time Frame
- From first dose to (up to 31 months) following first dose
- description
- Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
- measure
- Number of Participants With Laboratory Abnormalities
- time Frame
- From first dose to 30 days following last dose (Up to 30 Months)
- description
- Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
- measure
- Number of Participants With Laboratory Values Grade Shifting From Baseline
- time Frame
- From first dose to 30 days following last dose (Up to 30 Months)
Full study description
- brief Summary
- The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
Source references
- references
- citation
- Bergerot C, Yu S, Yang M, Martins B, Du M, Perez Torrealba J, Hall T, Samant N, Motzer RJ, Cella D. Identification of key symptoms impacting HRQOL in advanced renal cell carcinoma: nivolumab plus cabozantinib versus sunitinib in CheckMate 9ER. Oncologist. 2026 Aug 14:oyag329. doi: 10.1093/oncolo/oyag329. Online ahead of print.
- pmid
- 42605077
- type
- DERIVED
- citation
- Viray H, M Mantia C, Jegede OA, Atkins MB, Rosenblatt L, Choueiri TK, McDermott DF, Regan MM. Partitioned overall survival: comprehensive analysis of survival states over 4 years in CheckMate 9ER comparing first-line nivolumab plus cabozantinib versus sunitinib in advanced renal cell carcinoma. J Immunother Cancer. 2026 Jan 30;14(1):e013546. doi: 10.1136/jitc-2025-013546.
- pmid
- 41617395
- type
- DERIVED
- citation
- Grimm MO, Karim E, Kapetanakis V, Lothgren M, Ogareva A, Shukla P, Truscott J, Porta C. Two-Stage Estimation of Overall Survival in the Phase 3 CheckMate 9ER Trial, Adjusting for the Impact of Subsequent Therapy. Oncol Ther. 2026 Mar;14(1):253-268. doi: 10.1007/s40487-025-00393-9. Epub 2025 Nov 15.
- pmid
- 41239083
- type
- DERIVED
- citation
- Motzer RJ, Escudier B, Burotto M, Powles T, Apolo AB, Bourlon MT, Shah AY, Porta C, Suarez C, Barrios CH, Richardet M, Gurney H, Kessler ER, Tomita Y, Bedke J, Scheffold C, Askelson M, Panzica J, Zhang J, van Kooten Losio M, Choueiri TK. Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial. Ann Oncol. 2026 Jan;37(1):33-43. doi: 10.1016/j.annonc.2025.09.006. Epub 2025 Sep 23.
- pmid
- 40998092
- type
- DERIVED
- citation
- 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.
- pmid
- 39452894
- type
- DERIVED
- citation
- 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.
- pmid
- 38642472
- type
- DERIVED
- citation
- 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.
- pmid
- 37431849
- type
- DERIVED
- citation
- 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
- type
- DERIVED
- citation
- 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.
- pmid
- 36625894
- type
- DERIVED
- citation
- 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.
- pmid
- 36327527
- type
- DERIVED
- citation
- 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.
- pmid
- 35688173
- type
- DERIVED
- citation
- 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.
- pmid
- 35032437
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
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