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

    thomas.powles@bartshealth.nhs.uk

  • Sponsor organisation

    Eisai Ltd.

  • Eudract number

    2016-000916-14

  • Clinicaltrials.gov Identifier

    NCT02811861

  • 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