OncRef

Clinical Trial: NCT02811861

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Eisai Inc.
Information Provided By:Eisai Inc.
Last Update Posted:2026-02-23

Study Overview

Brief Summary

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review [IIR] using Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

Official 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)

Conditions

Renal Cell Carcinoma

Intervention / Treatment

  • Drug: Lenvatinib
  • Drug: Everolimus
  • Drug: Pembrolizumab
  • Drug: Sunitinib

Other Study ID Numbers

  • E7080-G000-307
  • KEYNOTE-581
  • 2016-000916-14
  • 2016

Start Date (Actual)

2016-10-13

Primary Completion Date (Actual)

2020-08-28

Study Completion Date (Estimated)

2027-03-31

Enrollment (Actual)

1069

Study Type

Interventional

Phase

Phase 3