We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Nivolumab Combined With Cabozantinib or Nivolumab and Ipilimumab 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03141177
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib or Nivolumab and Ipilimumab 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 Biological: Ipilimumab Drug: Cabozantinib Drug: Sunitinib Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1014 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 or Nivolumab and Ipilimumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : August 21, 2022


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm A (Doublet) Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558
Drug: Cabozantinib
Specified dose on specified days
Other Name: Carbometyx
Experimental: Arm B (Triplet) Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016
Drug: Cabozantinib
Specified dose on specified days
Other Name: Carbometyx
Experimental: Arm C Drug: Sunitinib
Specified dose on specified days.
Other Name: Sutent


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. PFS per BICR of Arm B versus Arm C [ Time Frame: Up to 22 months ]
    Intermediate/poor risk randomized participants


Secondary Outcome Measures :
  1. PFS per BICR of Arm A versus Arm C [ Time Frame: Up to 22 months ]
    In all randomized participants

  2. PFS per BICR of Arm B versus Arm C [ Time Frame: Up to 22 months ]
    In all randomized participants

  3. Overall Survival (OS) of Arm A versus Arm C [ Time Frame: Up to 34 months ]
    In all intermediate/poor risk randomized participants

  4. OS of Arm B versus Arm C [ Time Frame: Up to 34 months ]
    In all intermediate/poor risk randomized participants

  5. OS of Arm A versus Arm C [ Time Frame: Up to 34 months ]
    In all randomized participants

  6. OS of Arm B versus Arm C [ Time Frame: Up to 34 months ]
    In all randomized participants

  7. Objective Response Rate (ORR) [ Time Frame: Approximately 16 months ]
    In all intermediate/poor risk randomized and all randomized participants

  8. Incidence of adverse events (AEs) [ Time Frame: Up to 34 months ]
    Safety and Tolerability

  9. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 34 months ]
    Safety and Tolerability


Eligibility Criteria

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

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


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 117 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03141177     History of Changes
Other Study ID Numbers: CA209-9ER
2017-000759-20 ( EudraCT Number )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Sunitinib
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors