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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03141177
First received: May 3, 2017
Last updated: August 1, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Renal Cell Carcinoma Biological: Nivolumab Biological: Ipilimumab Drug: Cabozantinib Drug: Sunitinib Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1014
Actual Study Start Date: July 11, 2017
Estimated Study Completion Date: August 3, 2022
Estimated Primary Completion Date: February 15, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 83 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 )
Study First Received: May 3, 2017
Last Updated: August 1, 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

ClinicalTrials.gov processed this record on August 22, 2017