Eisai 218 - Efficacy of Lenvatinib/Everolimus in Renal Cell Carcinoma

• Research type

  Research Study

• Full title

  A Randomized, Open-label (formerly Double-blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination with Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment

• IRAS ID

  222144

• Contact name

  Hilary Glen

• Contact email

  hilary.glen@ggc.scot.nhs.uk

• Sponsor organisation

  Eisai Ltd,

• Eudract number

  2016-002778-11

• Duration of Study in the UK

  3 years, 4 months, 16 days

• Research summary

  Summary of Research

  This is a phase 2 double blind study of lenvatinib in combination with everolimus in participants with advanced renal cell cancer (RCC).

  Lenvatinib 18mg daily in combination with everolimus 5mg daily is currently approved in the USA and Europe for the treatment of Renal Cell Cancer after one prior treatment in adults. The purpose of this study is to assess if a lower starting dose of lenvatinib (14mg) in combination with everolimus 5mg is safer (fewer side effects), and just as effective when compared to the approved starting dose.

  This study will include approximately 306 participants from 100 centres globally.

  Participants will be assigned to one of two treatment groups in a 1:1 ratio (153 subjects in each treatment arm) to receive a starting dose of either:
  • Group A lenvatinib 18mg and everolimus 5mg orally once daily, or
  • Group B lenvatinib 14mg and everolumus 5mg orally once daily

  Study participation will last up to 48 months, including a screening period of up to 25 days, baseline / randomisation period, a treatment period which lasts from time of randomisation to completion of the ‘off treatment’ visit. Each treatment cycle is 28 days in duration. Participants who are assigned the group B arm and tolerate this well in the first 28 days without the need for dose to be lowered, will automatically receive the standard dose of lenvatinib 18mg and everolimus 5mg starting with the second cycle. Once participants stop treatment, they will be followed up every 12 weeks to assess disease status.

  The study involves procedures including: physical examinations, vital signs, blood and urine testing, electrocardiogram (ECG), echocardiogram (ECHO), MRI scans, radiological procedures such as CT scans, bone scans and MUGA scans, and questionnaires.

  This study is sponsored by Eisai Ltd / Eisai Co., Ltd.

  Summary of Results
  A copy of the Lay summary of results will be made available on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Feisaiclinicaltrials.com%252F.%2FNBTI%2FHke8AQ%2FAQ%2F78b7e899-62b8-42f8-a52e-8e2ecd99c185%2F2%2F8W-WC1PLq0&data=05%7C02%7Capprovals%40hra.nhs.uk%7C0bed6ccea9fc445188e808dd6d36225b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638786801458865086%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=uZDrBhGZdkLZypg30HXJUK%2FPGoLoOEMZ9JfNAzWkLnI%3D&reserved=0
  

• REC name

  West of Scotland REC 1

• REC reference

  17/WS/0124

• Date of REC Opinion

  14 Aug 2017

• REC opinion

  Further Information Favourable Opinion