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A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418922
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : November 22, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Lenvatinib Drug: Nivolumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Trial of Lenvatinib Plus Nivolumab in Subjects With Hepatocellular Carcinoma
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : October 18, 2022
Actual Study Completion Date : October 18, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Lenvatinib Plus Nivolumab
Participants will receive specified doses of lenvatinib (oral) and nivolumab (intravenous) on specified days.
 Drug: Lenvatinib
Specified doses will be administered orally on specified days.

Drug: Nivolumab
Specified doses will be administered intravenously 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.
 Drug: Lenvatinib
Specified doses will be administered orally on specified days.

Drug: Nivolumab
Specified doses will be administered intravenously on specified days.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  2. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418922


Locations
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Japan
Eisai Trial Site 1
Kashiwa, Chiba, Japan
Eisai Trial Site 6
Iizuka, Fukuoka, Japan
Eisai Trial Site 3
Kawasaki, Kanagawa, Japan
Eisai Trial Site 4
Osakasayama, Osaka, Japan
Eisai Trial Site 2
Chuo-ku, Tokyo, Japan
Eisai Trial Site 5
Chiba, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Ono Pharmaceutical Co. Ltd
More Information
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03418922    
Other Study ID Numbers: E7080-J081-117
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Nivolumab
Lenvatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors