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An Immunotherapy Study of Nivolumab Plus Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

NCT03873402

Description:

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.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: An Immunotherapy Study of Nivolumab Plus Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
  • Official Title: A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

Clinical Trial IDs

  • ORG STUDY ID: CA209-8Y8
  • SECONDARY ID: 2018-004695-35
  • NCT ID: NCT03873402

Conditions

  • Renal Cell Carcinoma

Interventions

DrugSynonymsArms
NivolumabOpdivoNivolumab + ipilimumab
IpilimumabYervoyNivolumab + ipilimumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + ipilimumabExperimental
  • Nivolumab
  • Ipilimumab
Nivolumab + ipilimumab placeboExperimental

    Eligibility Criteria

            For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
            visit www.BMSStudyConnect.com
    
            Inclusion Criteria:
    
              -  Histological confirmation of renal carcinoma with clear cell component including
                 participants who may have sarcomatoid features.
    
              -  Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma
                 (RCC) or metastatic RCC (mRCC).
    
              -  Measurable disease by CT or MRI per RECIST 1.1 criteria.
    
              -  No prior systemic therapy for RCC
    
              -  Must be intermediate or poor risk as per International Metastatic RCC Database
                 Consortium (IMDC).
    
            Exclusion Criteria:
    
              -  Any active central nervous system (CNS) metastases.
    
              -  Active, known, or suspected autoimmune disease.
    
              -  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 could apply
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression free survival (PFS)
    Time Frame:Up to 34 months
    Safety Issue:
    Description:Blinded independent central review (BICR) assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to 4 years
    Safety Issue:
    Description:
    Measure:Overall response rate (ORR)
    Time Frame:Up to 4 years
    Safety Issue:
    Description:BICR and investigator assessed per RECIST 1.1
    Measure:Disease control rate (DCR)
    Time Frame:Up to 4 years
    Safety Issue:
    Description:
    Measure:Duration of response (DoR)
    Time Frame:Up to 4 years
    Safety Issue:
    Description:
    Measure:Time to objective response (TTR)
    Time Frame:Up to 4 years
    Safety Issue:
    Description:
    Measure:PFS
    Time Frame:Up to 4 years
    Safety Issue:
    Description:investigator assessed per RECIST 1.1
    Measure:Incidence of adverse events (AEs)
    Time Frame:Up to 4 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated