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Trial ID CA209-8Y8  |   NCT03873402

A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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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 test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

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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 renal carcinoma with clear cell component including participants who may have sarcomatoid features.
    1. Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
      1. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
        1. No prior systemic therapy for RCC
          1. Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Any active central nervous system (CNS) metastases.
              1. Active, known, or suspected autoimmune disease.
                1. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Nivolumab + ipilimumab

                  ASSIGNED INTERVENTION
                  • Biological: Nivolumab, Ipilimumab

                  Study Arms

                  Experimental: Nivolumab + ipilimumab placebo

                  ASSIGNED INTERVENTION
                  • Other: Ipilimumab placebo

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