For Healthcare Professionals

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • Inclusion Criteria:


    1. Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
    2. 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

    Exclusion Criteria:


    1. Any active CNS metastases
    2. Any active, known or suspected autoimmune disease
    3. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
    4. Participants who have received a live/attenuated vaccine within 30 days of first treatment

    Other protocol defined inclusion/exclusion criteria could apply


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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Renal Cell Carcinoma

    Age (in years)

    18+

    Phase

    Phase 3

    Participants needed

    701

    Est. Completion Date

    Apr 17, 2024

    Treatment type

    Interventional


    Sponsor

    Bristol-Myers Squibb

    ClinicalTrials.gov identifier

    NCT03141177

    Study number

    CA2099ER

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