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About this trial

The purpose of this study is to test the safety and effectiveness of the research study drug, lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) compared to Sunitinib alone (Arm C), for the treatment of patients with advanced or metastatic renal cell carcinoma (RCC) who have not been treated for this condition.

Patients who are eligible to participate on this study will be assigned by chance to one of three treatment groups via a process called randomization. Patients assigned to treatment group one (Arm A) will receive lenvatinib and everolimus. Patients assigned to treatment group two (Arm B)will receive lenvatinib in combination with pembrolizumab. Patients assigned to treatment group three (Arm C)will receive sunitinib alone.

Patients will be asked to visit the study doctor for study treatment as long as their cancer is not getting worse or they do not have serious side effects. About 735 people will be in the study in total.

Patient Profile

For patients with advanced/metastatic renal cell carcinoma (kidney cancer).

Where’s this trial being run?

Beaumont Hospital, Cork University Hospital, Tallaght University Hospital, and University Hospital Galway

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information


Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: E7080-G000-307
Number: 16-69
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.

Principal Investigator: Prof Ray McDermott (Tallaght Hospital)
Type: Industry Sponsored


Recruitment Started: Global: October 2016
Ireland: May 2017
Global Recruitment Target: 735
Ireland Recruitment Target: 20