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

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.

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.

Future oncology (London, England). 2019 Jan 28 [Epub ahead of print]

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

Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany., Experimental Cancer Medicine, Barts Cancer Institute, London, UK., Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Urologic Oncology Program, Baylor University Medical Center, Dallas, TX, USA., University of Pavia & Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy., Department of Urology, Kyushu University, Fukuoka, Japan., Weill Cornell Medicine, New York-Presbyterian, New York, NY, USA., Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea., Eisai Inc., Woodcliff Lake, NJ, USA., Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

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