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A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Lenvatinib
Nivolumab
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eisai Trial Site 1
  • Eisai Trial Site 6
  • Eisai Trial Site 3
  • Eisai Trial Site 4
  • Eisai Trial Site 2
  • Eisai Trial Site 5

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Lenvatinib Plus Nivolumab

Part 2: Lenvatinib Plus Nivolumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Part 1 and Part 2: Number of Participants with Any Serious and/or Non-serious Adverse Event

Secondary Outcome Measures

Part 1 and Part 2: Overall Response Rate (ORR)
Part 1 and Part 2: Plasma Concentrations of Lenvatinib
Part 1 and Part 2: Serum Concentration of Nivolumab

Full Information

First Posted
January 26, 2018
Last Updated
August 14, 2023
Sponsor
Eisai Co., Ltd.
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03418922
Brief Title
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma
Official Title
A Phase 1b Trial of Lenvatinib Plus Nivolumab in Subjects With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Lenvatinib Plus Nivolumab
Arm Type
Experimental
Arm Description
Participants will receive specified doses of lenvatinib (oral) and nivolumab (intravenous) on specified days.
Arm Title
Part 2: Lenvatinib Plus Nivolumab
Arm Type
Experimental
Arm Description
If tolerable in Part 1, participants will receive specified doses of lenvatinib and nivolumab on specified days until criteria for discontinuation are met.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
Specified doses will be administered orally on specified days.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Specified doses will be administered intravenously on specified days.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame
Cycle 1 (28 days)
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Eisai Trial Site 1
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Eisai Trial Site 6
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site 3
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site 4
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site 2
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site 5
City
Chiba
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

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