Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients

Inclusion Criteria:

- Histologically or cytologically confirmed advanced (unresectable and/or metastatic)
HCC

- Patients with advanced HCC not amenable for surgical or loco-regional treatment

- At least one measureable tumor lesion that that has not been previously locally

- Patients with current cirrhotic status of Child-Pugh class A only (5-6 points with
total bilirubin < 2 mg/dL for dose-escalation) with no encephalopathy and no clinical
ascites (ascites controlled by diuretics is also excluded in this study).

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Patient must meet required laboratory values at the screening

- Normal electrocardiogram at screening

Exclusion Criteria:

- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

- Invasion of the main portal vein and/or tumor involvement in more than 50% of the
liver (applicable only for the dose-escalation part)

- Patients with Portal-caval shunts

- Prior or concomitant systemic anti-cancer treatment for advanced disease

- Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any
immunosuppressive therapy 7 days prior to planned date for first dose of study
treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.

- Cardiac or cardiac repolarization abnormality

- Patients with active Hepatitis B infection (HBsAg positive) that are not receiving
antiviral treatment are excluded

- Patients with positive test for hepatitis C ribonucleic acid (HCV RNA)

- Loco-regional treatment within 4 weeks prior to initiation of study treatment.