A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

• Locally advanced or unresectable HCC with diagnosis confirmed by histology/cytology by AASLD criteria in cirrhotic patients
• Not amenable to curative surgical and/or locoregional therapies
• No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC
• Measurable disease
• ECOG PS 0-2
• Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
• Life expectancy of at least 12 wks
• No prior tx with CD137 agonists or immunotherapy
• No known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
• No symptomatic or progressing CNS dz
• No co-infection with HBV or HCV
• No TIPS
• No ascites requring therapeutic paracentisis over past 3 months
• No history of spontaneous bacterial peritonitis over last 12 months

• Primary
  • Safety (percent of subjects with adverse events)
• Secondary
  • ORR
  • DOR
  • PFS
  • OS
  • QoL