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