This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which participants receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in combination with atezolizumab versus sorafenib in adults with advanced HCC who have not received previous systemic anticancer therapy in the advanced HCC setting. The primary objective of this study is to evaluate the effect of cabozantinib in combination with atezolizumab on the duration of progression-free survival (PFS) and duration of overall survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of single-agent cabozantinib compared with sorafenib in this patient population.
Supplied as 20-mg tablets; administered orally daily at 40 mg
Supplied as 60-mg tablets; administered orally once daily at 60 mg
Supplied as 200-mg tablets; administered orally twice daily at 400 mg
Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w
City of Buenos Aires, Buenos Aires, Argentina
City of Buenos Aires, Buenos Aires, Argentina
City of Buenos Aires, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina