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

Conditions

• Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 10, 2018

Status verified

Nov 2025

Primary completion

Nov 30, 2021

Completion

Jul 31, 2026

Study Design

Enrollment

837 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental arm
  Participants with advanced HCC will receive cabozantinib 40 milligrams (mg) oral, once daily (qd) + atezolizumab 1200 mg infusion, once every 3 weeks (q3w)
• Active Comparator: Control arm
  Participants with advanced HCC will receive sorafenib 400 mg twice a day (bid)
• Other: Single-Agent Cabozantinib arm
  Participants with advanced HCC will receive cabozantinib 60 mg qd

Primary Outcome Measure

Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population [ Time Frame: From the date of first participant randomization up to 28 months ]

Locations (33)

Related coverage on Hipa.ai

• Atezolizumab/Cabozantinib Combo Improves PFS in Advanced HCC Trial
  Atezolizumab · Dec 11, 2025 · ClinicalTrials.gov

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