A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2022-12-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Lenvatinib Plus Nivolumab

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

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type DRUG

Specified doses will be administered orally on specified days.

Nivolumab

Intervention Type DRUG

Specified doses will be administered intravenously on specified days.

Part 2: Lenvatinib Plus Nivolumab

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

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type DRUG

Specified doses will be administered orally on specified days.

Nivolumab

Intervention Type DRUG

Specified doses will be administered intravenously on specified days.

Interventions

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Lenvatinib

Specified doses will be administered orally on specified days.

Intervention Type DRUG

Nivolumab

Specified doses will be administered intravenously on specified days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No