Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: Study design and rationale

Viktor Grünwald, Thomas Powles, Toni K. Choueiri, Thomas E. Hutson, Camillo Porta, Masatoshi Eto, Cora N. Sternberg, Sun Young Rha, Cixin S. He, Corina E. Dutcus, Alan Smith, Lea Dutta, Kalgi Mody, Robert J. Motzer

Research output: Contribution to journalArticlepeer-review

18 Citations (Scopus)

Abstract

Aim: Lenvatinib plus everolimus is approved for the treatment of advanced renal cell carcinoma (RCC) after one prior vascular endothelial growth factor-targeted therapy. Lenvatinib plus pembrolizumab demonstrated promising antitumor activity in a Phase I/II trial of RCC. Methods: We describe the rationale and design of the CLEAR study, a three-arm Phase III trial comparing lenvatinib plus everolimus and lenvatinib plus pembrolizumab versus sunitinib monotherapy for first-line treatment of RCC. Eligible patients must have advanced clear cell RCC and must not have received any prior systemic anticancer therapy. The primary end point is progression-free survival; secondary end points include objective response rate, overall survival, safety, health-related quality of life and pharmacokinetics. Biomarker evaluations are included as exploratory end points.

Original languageEnglish
Pages (from-to)929-941
Number of pages13
JournalFuture Oncology
Volume15
Issue number9
DOIs
Publication statusPublished - 2019 Mar

Bibliographical note

Funding Information:
Here, we describe the design and rationale of the CLEAR study (NCT02811861; EudraCT 2016-000916-14), a multicenter, randomized, open-label and Phase III trial, designed to evaluate whether the combination of two targeted therapies (lenvatinib plus everolimus) or the combination of one targeted therapy plus a PD-1 inhibitor (lenvatinib plus pembrolizumab) would be superior to standard first-line therapy with single-agent sunitinib in patients with advanced or metastatic RCC. The study is funded by Eisai Inc., with study support also provided by Merck & Co., Inc.

Funding Information:
This study is funded by Eisai Inc., Woodcliff Lake, NJ, USA, and Merck & Co., Inc., Kenilworth, NJ, USA. Editorial support with the preparation of this manuscript was provided by Marcel Kuttab, PharmD, of Oxford PharmaGenesis Inc., Newtown, PA, USA, with funding provided by Eisai Inc.

Funding Information:
V Grünwald reports grants, personal fees and nonfinancial support from Bristol-Myers Squibb, Merck Sharp & Dohme and Novartis; personal fees and nonfinancial support from Roche and Ipsen; grants and personal fees from AstraZeneca and Pfizer; and personal fees from Eisai, EUSA Pharma and Cerulean.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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