E7080-J081-116 Lenvatinib Plus Pembrolizumab in Subjects with HCC
Research type
Research Study
Full title
An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects with Hepatocellular Carcinoma
IRAS ID
246044
Contact name
Tim Meyer
Contact email
Sponsor organisation
Eisai Ltd.
Eudract number
2018-000522-55
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND, 115650
Duration of Study in the UK
2 years, 6 months, 6 days
Research summary
This study will evaluate the combination of lenvatinib plus pembrolizumab in patients diagnosed as having advanced Hepatocellular carcinoma (liver cancer), which cannot be removed by surgery and which was not treated previously. The two study drugs are thought to work by inhibiting two different possible ways in which a cancer cell can grow and spread. The first part of this study has been completed already, in which the safe dose of lenvatinib and pembrolizumab in combination was determined. The highest safe dose was determined as 8 mg or 12 mg of lenvatinib per day (dose level of which is dependent on body weight) and pembrolizumab 200 mg by injection once every 3 weeks.
The purpose of the second part of this study, called “expansion”, is to use the highest safe dose of lenvatinib and pembrolizumab that can be given in combination, to determine the type, degree and frequency of side effects (symptoms and medical problems the patient may experience) as well as evaluate the efficacy (how well and for how long the study drug treated Hepatocellular Carcinoma). This study will also assess how the combination of lenvatinib and pembrolizumab is absorbed, distributed and excreted from the body. This study will involve participants that are 18 years and older with liver cancer that meet the study entry requirements. The starting dose level of lenvatinib is dependent on body weight, either 12 mg (Body Weight ≥60 kg) or 8 mg (Body Weight <60 kg) per day orally and pembrolizumab 200 mg once every 3 weeks intravenously (injected into a vein in the patient's arm) once every 3 weeks. Each treatment “Cycle” in this study is 21 days in duration. Pembrolizumab will be administered for up to 2 years after the first dose at the longest, however lenvatinib may continue. Treatment will continue until their cancer gets worse, development of unacceptable side effects, the participant no longer wants to continue in the study or the study is stopped. Once the patient stops both lenvatinib and pembrolizumab they will then go into follow-up.
Approximately 94 patients will take part in the expansion part of this study in about 32 research centres in United States of America, Canada, Russia and Europe.
This study is expected to take about 30 months to complete.REC name
London - Central Research Ethics Committee
REC reference
18/LO/1109
Date of REC Opinion
1 Aug 2018
REC opinion
Favourable Opinion