Background Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated
with encouraging overall survival in uncontrolled studies involving previously treated
patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study
compared nivolumab with everolimus in patients with renal-cell carcinoma who had
received previous treatment. Methods A total of 821 patients with advanced clear-cell renal-
cell carcinoma for which they had received previous treatment with one or two regimens of …

Background Nivolumab treatment resulted in superior efficacy and safety versus everolimus
treatment in the 2-year follow-up of the CheckMate 025 Phase III study, with consistent
results in the global population and the Japanese population. Here, we report the 3-year
follow-up in both groups. Methods Patients were randomized 1: 1 to nivolumab 3 mg/kg
intravenously every 2 weeks or everolimus 10 mg orally once daily until progression/
intolerable toxicity. The primary endpoint was overall survival (OS). Key secondary …