A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

A Phase 1b Trial of Lenvatinib Plus Nivolumab in Subjects With Hepatocellular Carcinoma

The primary objective of this study is to evaluate the tolerability and safety of a combination of lenvatinib plus nivolumab in participants with hepatocellular carcinoma (HCC).

Inclusion Criteria:

• Participants must have confirmed diagnosis of hepatocellular carcinoma (HCC) with any of the following criteria:

  • Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
  • Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection

• Part 1: HCC for which no other appropriate therapy is available; Part 2: No prior systemic therapy for advanced/unresectable HCC

• Participants categorized to stage B (not applicable for transarterial chemoembolization), or stage C based on Barcelona Clinic Liver Cancer staging system

• Child-Pugh score A

• Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 to 1

• Age greater than or equal to (>=) 20 years at the time of informed consent

Exclusion Criteria:

• Active co-infection with hepatitis B and hepatitis C
• Participants with any active, known, or suspected autoimmune disease
• Participants being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study
• Females who are breastfeeding or pregnant