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Trial record 1 of 1 for:    checkmate 9ER | Renal Cell Carcinoma
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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)

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ClinicalTrials.gov Identifier: NCT03141177
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 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 : July 11, 2017
Estimated Primary Completion Date : September 22, 2019
Estimated Study Completion Date : April 22, 2023


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




Primary Outcome Measures :
  1. Progression Free Survival (PFS) per blinded independent central review (BICR) [ Time Frame: Up to 21 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 64 months ]
  2. Objective Response Rate (ORR) [ Time Frame: Approximately 16 months ]
  3. Incidence of adverse events (AEs) [ Time Frame: Up to 64 months ]
    Safety and Tolerability

  4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 64 months ]
    Safety and Tolerability



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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

Other protocol defined inclusion/exclusion criteria could apply


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 130 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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: July 3, 2018
Last Verified: July 2018

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
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Nivolumab
Sunitinib
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors