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.
KEYNOTE-564, 0 NCT03142334
pembrolizumab alone (n=496) vs. placebo (n=498)
randomized controlled trial
pembrolizumab
pembrolizumab: IV 200 mg every 3 weeks
213 sites in 21 countries (Asia, Australia, Europe, North and South America)
P3 / DFS at 0.025 at 1-sided (with 1IA: p=0.0122, final: p=0.0214), if significant then OS at 0.025 at 1-sided(with 3IA, 1st: p=0.0011, 2nd=0.0055, 3rd: p=0.0138 and final: p=0.0200)