A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 28 August 2023
• Main ID: NCT03418922
• Date of registration: 26/01/2018
• Prospective Registration: Yes
• Primary sponsor: Eisai Co., Ltd.
• Public title: A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma
• Scientific title: A Phase 1b Trial of Lenvatinib Plus Nivolumab in Subjects With Hepatocellular Carcinoma
• Date of first enrolment: January 30, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03418922
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Hepatocellular

Intervention(s)

Drug: Nivolumab

Drug: Lenvatinib

Primary Outcome(s)

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

Part 1 and Part 2: Number of Participants with Any Serious and/or Non-serious Adverse Event [Time Frame: From the date of screening until 30 days after the last dose (up to 41 months)]

Secondary Outcome(s)

Part 1 and Part 2: Serum Concentration of Nivolumab [Time Frame: Part 1 and Part 2, Cycle 1 and 5 Day 1: Pre-dose and Just before completion of administration, Cycles 1 and 5 Day 15, Cycle 2, 3, 4, 9, 13 Day 1: Pre-dose, thereafter every 4 cycles Day 1: Pre-dose (Cycle length=28 days)]

Part 1 and Part 2: Plasma Concentrations of Lenvatinib [Time Frame: Part 1, Cycle 1 Days 1 and 15: Pre-dose-24 hours, thereafter every Cycle Day 1 (Up to Cycle 24): Pre-dose; Part 2, Cycle 1 Day 1: 0.5-4 hours, Cycle 1 Day 15: Pre-dose-4 hours, Cycle 2, 4, 6 Day 1: Pre-dose (Cycle length is equal to [=] 28 days)]

Part 1 and Part 2: Overall Response Rate (ORR) [Time Frame: From the date of screening until the last observation visit (up to 41 months)]

Secondary ID(s)

E7080-J081-117

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd