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FDA Approves Nivolumab/Ipilimumab for Frontline RCC

Jason M. Broderick @jasoncology
Published: Monday, Apr 16, 2018

Robert J. Motzer, MD

Robert J. Motzer, MD
The FDA has approved the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC).

CheckMate-214 included patients with advanced or metastatic clear cell RCC who were treatment-naïve. Patients were randomized 1:1 to nivolumab, 3 mg/kg, plus ipilimumab, 1 mg/kg, every 3 weeks for 4 doses, followed by nivolumab, 3 mg/kg every 2 weeks; or to receive oral sunitinib, 50 mg a day for 4 weeks in 6-week cycles. Patients were stratified by risk group and region, and treatment was continued until disease progression or unacceptable toxicity.

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