A Study of Atezolizumab with Lenvatinib or Sorafenib versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated with Atezolizumab and Bevacizumab

Prior treatment

• Significant cardiovascular disease within 3 months prior to initiation of study treatment
• Treatment with an investigational therapy within 28 days prior to initiation of study treatment

Other illness

• History of leptomeningeal disease and hepatic encephalopathy
• History of malignancy other than HCC within 5 years prior to screening
• Known allergy or hypersensitivity to any of the investigational medicinal product (IMPs) or constituents of the products

Other

• Symptomatic, untreated, or actively progressing central nervous system metastases

• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients
  • Patients without cirrhosis require histological confirmation of diagnosis. HCC must be unamenable to curative surgical and/or locoregional therapies, or have progressed after surgical and /or locoregional therapies
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 7 days prior to randomization
  • Child-Pugh class A within 7 days prior to randomization
  • Life expectancy of at least 12 weeks
  • Patients with active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 international units per milliliter (IU/mL) obtained within 28 days prior to initiation of study treatment and received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study