Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab), as adjuvant treatment of localized renal cell carcinoma or RCC, did not meet the primary endpoint.
CheckMate 025, 2015 NCT01668784
nivolumab alone (n=410) vs. everolimus (n=411)
randomized controlled trial
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.