CheckMate 459, 2019 NCT02576509
nivolumab alone (n=371) vs. sorafenib (n=372)
randomized controlled trial
nivolumab
NIVO 240 mg IV Q2W
sorafenib
Sorafenib (400 mg oral BID).
mHCC - 1st line (L1)
open label
at medical centres in 22 countries and territories in Asia, Australasia, Europe, and North America
P3 / OS at 2-sided at 0.05 with one IA (at 0.024) and one final analysis (at 0.043). Hierarchical testing: OS > ORR > PFS
this study did not meet its primary endpoint OS