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Trial ID CA209-9ER  |   NCT03141177

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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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Key Eligibility Criteria

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

Inclusion Criteria

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:
  • Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
    1. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
      1. No prior systemic therapy for RCC with the following exception:
        1. 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 Icon
        :
        • Any active CNS metastases
          1. Any active, known or suspected autoimmune disease
            1. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
              1. Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria could apply
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Doublet

                ASSIGNED INTERVENTION
                • Biological: Nivolumab
                • Drug: Cabozantinib

                Study Arms

                Active Comparator: Monotherapy

                ASSIGNED INTERVENTION
                • Drug: Sunitinib

                Study Arms

                Experimental: Triplet

                ASSIGNED INTERVENTION
                • Biological: Ipilimumab

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