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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
Last Update Posted : February 12, 2021
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
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE July 11, 2017
Actual Primary Completion Date February 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Progression Free Survival (PFS) per blinded independent central review (BICR) [ Time Frame: Up to 29 months ]
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: April 24, 2020)
  • Overall Survival (OS) [ Time Frame: Up to 40 months ]
  • Objective Response Rate (ORR) [ Time Frame: up to 29 months ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to 40 months ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 40 months ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 40 months ]
  • Incidence of Deaths [ Time Frame: Up to 40 months ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 40 months ]
  • Change from baseline in Laboratory values [ Time Frame: Up to 40 Months ]
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
Estimated Enrollment  ICMJE
 (submitted: April 24, 2020)
638
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)
1014
Estimated Study Completion Date  ICMJE May 14, 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
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Exelixis
  • Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2021

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