NCT03755791

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 837 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Supplied as 20-mg tablets; administered orally daily at 40 mg
DRUG	Cabozantinib	Supplied as 60-mg tablets; administered orally once daily at 60 mg
DRUG	Sorafenib	Supplied as 200-mg tablets; administered orally twice daily at 400 mg
DRUG	Atezolizumab	Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w

Timeline

• Start date: 2018-06-10
• Primary completion: 2021-11-30
• Completion: 2026-07-31
• First posted: 2018-11-28
• Last updated: 2025-12-11
• Results posted: 2025-12-11

Locations

245 sites across 34 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Georgia, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study