A Phase I Dose Escalation Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects With or Without Chronic Viral Hepatitis

Inclusion Criteria:

- Subjects with histological confirmation of advanced hepatocellular carcinoma;
subjects must have progressive disease following or be intolerant of at least one
line of therapy or refuse sorafenib treatment; subjects must be off sorafenib
treatment for at least 28 days prior to first dose

- Child-Pugh score of A

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

Exclusion Criteria:

- Subjects with brain metastasis

- Encephalopathy

- Any prior or current ascites requiring paracentesis for control; any history of
clinically meaningful variceal bleeding within the last three months

- Active coinfection with both hepatitis B and C

- Hepatitis D infection in subjects with hepatitis B