Trial of Atezolizumab and Bevacizumab With CHS-388 or Placebo in Patients With Hepatocellular Carcinoma
brief summary
This was a Phase 2 trial composed of an open label Lead-In followed by a planned Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC. Only the Lead-In Phase of the study was completed.
detailed description
This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC.
After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).
official title
A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With CHS-388 (Formerly Known as SRF388) or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma.