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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.
 
ClinicalTrials.gov Identifier: NCT03141177
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Results First Posted : April 26, 2022
Last Update Posted : January 17, 2024
Sponsor:
Collaborators:
Exelixis
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Sunitinib
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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").

  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03141177


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] May 3, 2019
Statistical Analysis Plan  [PDF] December 11, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03141177    
Other Study ID Numbers: CA209-9ER
2017-000759-20 ( EudraCT Number )
First Posted: May 4, 2017    Key Record Dates
Results First Posted: April 26, 2022
Last Update Posted: January 17, 2024
Last Verified: January 2024

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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
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
 Male Urogenital Diseases
Nivolumab
Ipilimumab
Sunitinib
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