Status:
ACTIVE_NOT_RECRUITING
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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 computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (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
- 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 apply
Key Trial Info
Start Date :
June 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT03873402
Start Date
June 21 2019
End Date
August 29 2025
Last Update
March 12 2025
Active Locations (78)
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1
Local Institution - 0013
Washington D.C., District of Columbia, United States, 20007
2
Local Institution - 0053
Athens, Georgia, United States, 30607
3
Local Institution - 0066
Boston, Massachusetts, United States, 02114
4
Local Institution - 0088
Boston, Massachusetts, United States, 02114