E7080-G000-307 CLEAR
Research type
Research Study
Full title
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR)
IRAS ID
217785
Contact name
Thomas Powles
Contact email
Sponsor organisation
Eisai Ltd.
Eudract number
2016-000916-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
This is an open-label, which means both researcher and participants will know which treatment is being administered, single arm, multicentre Phase 3 study. The purpose of the study is to compare how effective and safe the use of lenvatinib in combination with everolimus or pembrolizumab versus sunitinib as first-line treatment in participants with advanced renal cell carcinoma. The study drugs are thought to work by stopping different possible ways in which a tumour cells can grow and spread.
Participants taking part in the study will be assigned to one of three treatment groups:
Arm A: lenvatinib 18mg (by mouth) plus everolimus 5 mg (by mouth)
Arm B: lenvatinib 20mg (by mouth) plus pembrolizumab 200mg (into a vein) every 3 weeks.
Arm C: sunitinib 50mg (by mouth) on a schedule of 4 weks on treatment followed by 2 weeks off.The study will involve participants that are 18 years and older with advanced renal cell carcinoma that meet the study entry requirements. It consists of 3 Phases: Pre-randomisation phase (Screening and Baseline visit), randomisation phase (Treatment and follow-up period) and an extension phase. The participant will remain on treatment until disease progression, and will then go into lifetime follow-up.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/0409
Date of REC Opinion
17 Mar 2017
REC opinion
Favourable Opinion