Open AccessLenvatinib Plus Everolimus or Pembrolizumab Versus Sunitinib in Advanced Renal Cell Carcinoma: Study Design and Rationale
Author(s) -
Viktor Grünwald,
Thomas Powles,
Toni K. Choueiri,
Thomas E. Hutson,
Camillo Porta,
Masatoshi Eto,
Cora N. Sternberg,
Sun Young Rha,
Cixin He,
Corina E. Dutcus,
Alan D. Smith,
Lea Dutta,
Kalgi Mody,
Robert J. Motzer
Publication year - 2019
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2018-0745
Subject(s) - lenvatinib , medicine , everolimus , sunitinib , pembrolizumab , oncology , renal cell carcinoma , clinical endpoint , kidney cancer , clinical trial , sorafenib , cancer , hepatocellular carcinoma , immunotherapy
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.
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