A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

Sponsor
Eisai Co., Ltd.
Study ID
NCT03418922
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Specified doses will be administered orally on specified days.
  • Nivolumab — DRUG
    Specified doses will be administered intravenously on specified days.

Study Details

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).

Key Dates

Start date
Jan 16, 2018
Status verified
May 2022
Primary completion
Dec 28, 2022
Completion
Dec 28, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Lenvatinib Plus Nivolumab
    Participants will receive specified doses of lenvatinib (oral) and nivolumab (intravenous) on specified days.
  • Experimental: 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.

Primary Outcome Measure

Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Cycle length = 28 days) ]

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