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A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03141177
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : October 18, 2021
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Nivolumab Drug: Cabozantinib Drug: Sunitinib Biological: Ipilimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Doublet
Nivolumab and Cabozantinib
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Drug: Cabozantinib
Specified dose on specified days
Other Name: Cabometyx

Active Comparator: Monotherapy
Drug: Sunitinib
Specified dose on specified days.
Other Name: Sutent

Experimental: Triplet

Nivolumab, Ipilimumab, Cabozantinib

*Enrollment to the triplet arm was discontinued by protocol amendment

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Primary Outcome Measures :
  1. Progression Free Survival (PFS) per blinded independent central review (BICR) [ Time Frame: Up to 29 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 40 months ]
  2. Objective Response Rate (ORR) [ Time Frame: up to 29 months ]
  3. Incidence of adverse events (AEs) [ Time Frame: Up to 40 months ]
  4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 40 months ]
  5. Incidence of AEs leading to discontinuation [ Time Frame: Up to 40 months ]
  6. Incidence of Deaths [ Time Frame: Up to 40 months ]
  7. Incidence of laboratory abnormalities [ Time Frame: Up to 40 months ]
  8. Change from baseline in Laboratory values [ Time Frame: Up to 40 Months ]

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03141177

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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb Identifier: NCT03141177    
Other Study ID Numbers: CA209-9ER
2017-000759-20 ( EudraCT Number )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors