An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

Eisai Clinical Trials

Protocol # E7080-J081-116

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT03006926, 2018-000522-55, JapicCTI-173494, jRCT2080223439

Trial Period: Feb 2017 - Nov 2022

Indication: Hepatocellular Carcinoma (HCC)

Primary Endpoint:
1. DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From first dose until 120 days after the last dose (up to 50.2 months)]

2. Expansion Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From first dose until 120 days after the last dose (up to 50.2 months)]

Population
Males and females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 1
Countries
France, Italy, Japan, Russian Federation, Spain, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR