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

E7080-J081-117

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).

2018-01-30

2022-12-28

2022-12-28

Completed

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-08-15