A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
AstraZeneca
Summary
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
Description
The purpose of this study is to assess the efficacy and tolerability of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line treatment in participants with advanced HCC. The study comprises 2 parts - a safety lead-in and a randomised period. Prior to the start of the randomised period of the study, a single-arm safety lead-in period will be applied to evaluate the safety and tolerability of rilvegostomig in combination with bevacizumab and tremelimumab.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Locally advanced or metastatic and/or unresectable HCC * WHO/ECOG performance status of 0 or 1 * BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A * At least one measurable target lesion * co-infected with HBV and HCV are not eligible * Adequate organ and bone marrow function measured during the screening period * Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC. * Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoreg…
Interventions
- DrugTremelimumab
IV therapy
- DrugRilvegostomig
IV therapy
- DrugBevacizumab
IV therapy
- DrugAtezolizumab
IV therapy
Locations (204)
- Research SitePhoenix, Arizona
- Research SiteTucson, Arizona
- Research SitePalo Alto, California
- Research SiteSanta Monica, California
- Research SiteNew Haven, Connecticut
- Research SiteNewark, Delaware