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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 : September 16, 2022
Sponsor:
Collaborators:
Exelixis
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 4, 2017
Results First Submitted Date  ICMJE February 11, 2022
Results First Posted Date  ICMJE April 26, 2022
Last Update Posted Date September 16, 2022
Actual Study Start Date  ICMJE August 22, 2017
Actual Primary Completion Date February 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2022)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C [ Time Frame: Up to 22 months ]
    Intermediate/poor risk randomized participants
  • PFS per BICR of Arm B versus Arm C [ Time Frame: Up to 22 months ]
    Intermediate/poor risk randomized participants
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2022)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • PFS per BICR of Arm A versus Arm C [ Time Frame: Up to 22 months ]
    In all randomized participants
  • PFS per BICR of Arm B versus Arm C [ Time Frame: Up to 22 months ]
    In all randomized participants
  • Overall Survival (OS) of Arm A versus Arm C [ Time Frame: Up to 34 months ]
    In all intermediate/poor risk randomized participants
  • OS of Arm B versus Arm C [ Time Frame: Up to 34 months ]
    In all intermediate/poor risk randomized participants
  • OS of Arm A versus Arm C [ Time Frame: Up to 34 months ]
    In all randomized participants
  • OS of Arm B versus Arm C [ Time Frame: Up to 34 months ]
    In all randomized participants
  • Objective Response Rate (ORR) [ Time Frame: Approximately 16 months ]
    In all intermediate/poor risk randomized and all randomized participants
  • Incidence of adverse events (AEs) [ Time Frame: Up to 34 months ]
    Safety and Tolerability
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 34 months ]
    Safety and Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified day
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: Cabozantinib
    Specified dose on specified days
    Other Name: Cabometyx
  • Drug: Sunitinib
    Specified dose on specified days.
    Other Name: Sutent
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • Yervoy
    • BMS-734016
Study Arms  ICMJE
  • Experimental: Doublet
    Nivolumab and Cabozantinib
    Interventions:
    • Biological: Nivolumab
    • Drug: Cabozantinib
  • Active Comparator: Monotherapy
    Sunitinib
    Intervention: Drug: Sunitinib
  • Experimental: Triplet

    Nivolumab, Ipilimumab, Cabozantinib

    *Enrollment to the triplet arm was discontinued by protocol amendment

    Intervention: Biological: Ipilimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 13, 2021)
701
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)
1014
Estimated Study Completion Date  ICMJE April 17, 2024
Actual Primary Completion Date February 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Chile,   Czechia,   Germany,   Greece,   Israel,   Italy,   Japan,   Mexico,   Poland,   Romania,   Russian Federation,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT03141177
Other Study ID Numbers  ICMJE CA209-9ER
2017-000759-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Exelixis
  • Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP