A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)
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|ClinicalTrials.gov Identifier: NCT03141177|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Results First Posted : April 26, 2022
Last Update Posted : December 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Biological: Nivolumab Drug: Cabozantinib Drug: Sunitinib Biological: Ipilimumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||701 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma|
|Actual Study Start Date :||August 22, 2017|
|Actual Primary Completion Date :||February 12, 2020|
|Estimated Study Completion Date :||April 17, 2024|
Nivolumab and Cabozantinib
Specified dose on specified day
Specified dose on specified days
Other Name: Cabometyx
Active Comparator: Monotherapy
Specified dose on specified days.
Other Name: Sutent
Nivolumab, Ipilimumab, Cabozantinib
*Enrollment to the triplet arm was discontinued by protocol amendment
Specified dose on specified days
- 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) ]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
- Overall Survival (OS) [ Time Frame: From randomization date to death date (Up to 31 months) ]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").
- Objective Response Rate (ORR) [ Time Frame: Up to 31 Months ]
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.
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose to 100 days following last dose (Up to 32 Months) ]Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
- Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: From first to dose to 100 days following last dose (Up to 32 months) ]Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
- 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) ]Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
- Number of Deaths [ Time Frame: From first dose to (up to 31 months) following first dose ]Number of deaths due to any cause during the specified time frame.
- Number of Participants With Laboratory Abnormalities [ Time Frame: From first dose to 30 days following last dose (Up to 30 Months) ]Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
- 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) ]Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141177
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Bristol-Myers Squibb|
|Other Study ID Numbers:||
2017-000759-20 ( EudraCT Number )
|First Posted:||May 4, 2017 Key Record Dates|
|Results First Posted:||April 26, 2022|
|Last Update Posted:||December 21, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Modulating Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors