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Overview Studies Clinical Trials

Active Not Recruiting PHASE3 INTERVENTIONAL 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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Cabozantinib

Type: DRUG

Description: Supplied as 20-mg tablets; administered orally daily at 40 mg

Name: Cabozantinib

Type: DRUG

Description: Supplied as 60-mg tablets; administered orally once daily at 60 mg

Name: Sorafenib

Type: DRUG

Description: Supplied as 200-mg tablets; administered orally twice daily at 400 mg

Name: Atezolizumab

Type: DRUG

Description: Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w

Primary Outcomes

Measure: Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population

TimeFrame: From the date of first participant randomization up to 28 months

Description: PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Measure: Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population

TimeFrame: From the date of first participant randomization up to 36 months

Description: OS was defined as the time from randomization to death due to any cause.

Trial Information

NCT ID

NCT03755791

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Exelixis

Last Updated

December 15, 2025