ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Inclusion Criteria

• Men or women, Age ≥18 years
• Patients with ECOG performance status 0 or 1
• Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy
• Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent
• Patients with at least one prior systemic therapy for HCC
• Patients eligible to be treated with nivolumab
• Patients with measurable disease based on RECIST v1.1
• Patients with Child-Pugh class A liver score within 7 days of first study dose
• Patients with no history of hepatic encephalopathy
• Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible)
• Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be <100 IU/mL within 7 days of first study dose
• Patients with no active co-infection with HBV and HCV or HBV and HDV
• Patients with no active drug or alcohol abuse

Exclusion Criteria

• Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose
• Patients with esophageal or gastric variceal bleeding within the past 6 months
• Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging
• Patients with previous solid organ or hematologic transplantation
• Patients with active autoimmune disease requiring systemic treatment in the past 2 years
• Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose
• Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose
• Patients with minor surgery to liver or another site within 1 week before first study dose