Status:
COMPLETED
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma
Lead Sponsor:
Eisai Co., Ltd.
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03418922
Start Date
January 16 2018
End Date
December 28 2022
Last Update
June 20 2024
Active Locations (6)
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1
Eisai Trial Site 1
Kashiwa, Chiba, Japan
2
Eisai Trial Site 6
Iizuka, Fukuoka, Japan
3
Eisai Trial Site 3
Kawasaki, Kanagawa, Japan
4
Eisai Trial Site 4
Sayama, Osaka, Japan