Phase III Study of Rilvegostomig With Bevacizumab With or Without Tremelimumab Compared to Atezolizumab Plus Bevacizumab for First-Line Treatment of Advanced Hepatocellular Carcinoma

What this Trial Is About

This research evaluates the efficacy and safety of rilvegostomig combined with bevacizumab, with or without tremelimumab, compared to atezolizumab with bevacizumab as first-line treatment for participants with advanced hepatocellular carcinoma HCC who cannot undergo curative or locoregional therapies. This Phase III, randomized, open-label, sponsor-blinded, global study includes a safety lead-in period before the randomized phase to assess tolerability. Participants receive treatments through intravenous therapy in one of three groups rilvegostomig with bevacizumab and tremelimumab, rilvegostomig with bevacizumab, or atezolizumab with bevacizumab. The study has two parts the initial safety lead-in to evaluate the combination of rilvegostomig, bevacizumab, and tremelimumab, followed by a randomized period comparing the three treatment arms. Throughout the study, participants are monitored for overall survival and safety outcomes for up to approximately six years. Assessments include evaluation of tumor response, immune response, adverse events, and subgroup analysis based on PD-L1 expression. Participants must meet specific health and disease criteria at screening and will receive regular follow-up during the studys duration.

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma