nivolumab plus ipilimumab (n=14) vs. nivolumab alone (n=13)
randomized controlled trial
nivolumab plus ipilimumab
480 mg of nivolumab IV every 4 weeks plus 1 mg/kg of ipilimumab IV every 6 weeks up to 4 doses before and after surgery
nivolumab
240 mg of nivolumab intravenously (IV) every 2 weeks alone
mHCC - (neo)adjuvant (NA)
Patient can have had prior treatment for HCC including prior surgery, radiation therapy, local-regional therapy (ablation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy
open design
single-center
The goal of this arm was to study if unresectable localized disease will have adequate tumor shrinkage to become resectable.
HIMALAYA, 2022 NCT03298451
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
CheckMate 9DW, 2024 NCT04039607
nivolumab plus ipilimumab plus SoC (n=-9) vs. VEGF(R) inhibitor (n=-9)
randomized controlled trial
nivolumab and ipilimumab
Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg Q4W