TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer

Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular cancer * Barcelona Clinic Liver Cancer Stage B or C * Cirrhosis grade of Child-Pugh class A or B7 * Subjects with HBV infection are required to be receiving effective antiviral therapy and have a viral load less than 100 IU/mL. Antiviral therapy is not required for subjects with HCV infection * Have at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1) * No prior systemic therapy for HCC * Age ≥ 18 years * ECOG performance status 0-1 * Resolved acute effects of any prior therapy to baseline or Grade ≤1 NCI CTCAE * Have adequate hematologic function as documented by ANC ≥ 1000/μcl, platelet count ≥ 60,000/μcl, and hemoglobin ≥ 8.5 mg/dl * Have adequate renal function as determined by a measured or calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault formula * Have adequate hepatic function, as documented by ALT and AST ≤5x upper limit of normal, total bilirubin ≤3 mg/dL, and albumin ≥2.8 g/dL * International normalized ratio (INR) or prothrombin time (PT) ≤2× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants * Prior local therapy, such as surgery, radioembolization, chemoembolization, or radiofrequency ablation is allowed if the index lesion(s) remains outside of the treatment field or has progress…