durvalumab plus tremelimumab (n=393) vs. sorafenib (n=389)
randomized controlled trial
durvalumab and tremelimumab
tremelimumab 300 mg in combination with durvalumab 1,500 mg followed by durvalumab 1,500 mg every 4 weeks
sorafenib
sorafenib 400 mg twice daily
3 arms : a single dose of tremelimumab 300 mg in combination with durvalumab 1,500 mg followed by durvalumab 1,500 mg every 4 weeks,durvalumab 1,500 mg every 4 weeks monotherapy sorafenib 400 mg twice daily
mHCC - 1st line (L1)
open design
181 sites in 16 countries
Originally, there were four treatment groups with patients randomly assigned 1:1:1:1. Enrollement in T75 D arm (75 mg of tremelimumab every 4 weeks for four doses plus 1500 mg of durvalumab every 4 weeks) was closed regarding results from Study 22. The protocol was amended to randomly assign patients 1:1:1 to receive STRIDE, durvalumab, or sorafenib