A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Lenvatinib; Nivolumab

Criteria

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