A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

Eisai

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Lenvatinib; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03418922

E7080-J081-117

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Part 1: Lenvatinib Plus Nivolumab

Experimental group

Description:

Participants will receive specified doses of lenvatinib (oral) and nivolumab (intravenous) on specified days.

Treatment:

Drug: Nivolumab

Drug: Lenvatinib

Part 2: Lenvatinib Plus Nivolumab

Experimental group

Description:

If tolerable in Part 1, participants will receive specified doses of lenvatinib and nivolumab on specified days until criteria for discontinuation are met.

Treatment:

Drug: Nivolumab

Drug: Lenvatinib