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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03873402

Run by

Bristol-Myers Squibb

People needed

437

Starts

2019-06-21

Expected to finish

2027-03-11

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Local Institution - 0053 — Athens, Georgia, United States
• Local Institution - 0066 — Boston, Massachusetts, United States
• Local Institution - 0088 — Boston, Massachusetts, United States
• Local Institution - 0086 — Boston, Massachusetts, United States
• The Reading Hosp Med Ctr Reg Cancer Ctr — West Reading, Pennsylvania, United States
• Local Institution - 0084 — Charleston, South Carolina, United States
• Local Institution - 0100 — Capital Federal, Buenos Aires, Argentina
• Local Institution - 0011 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0060 — Mar del Plata, Buenos Aires, Argentina
• Local Institution - 0025 — Río Cuarto, Córdoba Province, Argentina
• Local Institution - 0001 — Viedma, Río Negro Province, Argentina
• Local Institution - 0005 — Córdoba, Argentina
• Local Institution - 0002 — San Juan, Argentina
• Local Institution - 0033 — Graz, Austria
• Local Institution - 0031 — Vienna, Austria
• Local Institution - 0032 — Wels, Austria
• Local Institution - 0017 — Independencia, Santiago Metropolitan, Chile
• Local Institution - 0003 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0034 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0004 — Viña del Mar, Valparaiso, Chile
• Local Institution - 0012 — Viña El Mar, Valparaiso, Chile
• Local Institution - 0020 — Brno, South Moravian, Czechia
• Local Institution - 0097 — Brno, Czechia
• Local Institution - 0019 — Prague, Czechia
• Local Institution - 0013 — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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