A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03873402
This study evaluates the safety and efficacy of nivolumab with ipilimumab versus nivolumab alone in untreated advanced kidney cancer. Eligible participants must have histologically confirmed renal carcinoma with a clear cell component, advanced or metastatic RCC, measurable disease per RECIST 1.1, no prior RCC systemic therapy, and be intermediate or poor risk per IMDC.
Patient Parameters
| Parameter | Options |
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Program 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.
Eligibility Criteria
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 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 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 apply
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0013 | 20007 | Washington D.C. | District of Columbia |
| Local Institution - 0053 | 30607 | Athens | Georgia |
| Local Institution - 0066 | 02114 | Boston | Massachusetts |
| Local Institution - 0088 | 02114 | Boston | Massachusetts |
| Local Institution - 0086 | 02215 | Boston | Massachusetts |
| The Reading Hosp Med Ctr Reg Cancer Ctr | 19611 | West Reading | Pennsylvania |
| Local Institution - 0084 | 29414 | Charleston | South Carolina |
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