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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population — From the date of first participant randomization up to 28 months
  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.
• Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population — From the date of first participant randomization up to 36 months
  OS was defined as the time from randomization to death due to any cause.

Trial sites (245)

+ 205 more sites — see the full list on the official registry below.

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