nivolumab
3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks
everolimus
10-mg everolimus tablet orally once daily
Dose modifications were not permitted for nivolumab but were permitted for everolimus
metastatic/advanced RCC (mRCC) - 2nd line (L2)
Key exclusion criteria were metastasis to the central nervous system, previous treatment with an mTOR inhibitor. All patients had a Karnofsky performance status of at least 70 at the time of study entry
open-label
146 sites in 24 countries in North America, Europe, Australia, South America, and Asia;
P3 / two-sided test procedure with one interim analysis. Hierarchical statistical testing procedure (OS then PFS)
Among patients with previously treated advanced renal-cell carcinoma, overall survival was significantly longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus.