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

doi:10.2217/fon-2018-0745

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

Istituti Clinici Scientifici Maugeri Spa – Società Benefit

Research output: Contribution to journal › Article › peer-review

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 language	English
Pages (from-to)	929-941
Number of pages	13
Journal	Future Oncology
Volume	15
Issue number	9
DOIs	https://doi.org/10.2217/fon-2018-0745
Publication status	Published - Mar 2019

Keywords

Adult
Antibodies, Monoclonal, Humanized/pharmacokinetics
Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics
Biomarkers, Tumor/analysis
Carcinoma, Renal Cell/drug therapy
Clinical Trials, Phase III as Topic
Everolimus/pharmacokinetics
Female
Humans
Kidney Neoplasms/drug therapy
Male
Multicenter Studies as Topic
Phenylurea Compounds/pharmacokinetics
Progression-Free Survival
Quality of Life
Quinolines/pharmacokinetics
Randomized Controlled Trials as Topic
Sunitinib/pharmacokinetics
Survival Analysis
Young Adult

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Grünwald, V., Powles, T., Choueiri, T. K., Hutson, T. E., Porta, C., Eto, M., Sternberg, C. N., Rha, S. Y., He, C. S., Dutcus, C. E., Smith, A., Dutta, L., Mody, K., & Motzer, R. J. (2019). Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: study design and rationale. Future Oncology, 15(9), 929-941. https://doi.org/10.2217/fon-2018-0745

Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma : study design and rationale. / Grünwald, Viktor; Powles, Thomas; Choueiri, Toni K; Hutson, Thomas E; Porta, Camillo; Eto, Masatoshi; Sternberg, Cora N; Rha, Sun Young; He, Cixin S; Dutcus, Corina E; Smith, Alan; Dutta, Lea; Mody, Kalgi; Motzer, Robert J.

In: Future Oncology, Vol. 15, No. 9, 03.2019, p. 929-941.

Research output: Contribution to journal › Article › peer-review

Grünwald, Viktor ; Powles, Thomas ; Choueiri, Toni K ; Hutson, Thomas E ; Porta, Camillo ; Eto, Masatoshi ; Sternberg, Cora N ; Rha, Sun Young ; He, Cixin S ; Dutcus, Corina E ; Smith, Alan ; Dutta, Lea ; Mody, Kalgi ; Motzer, Robert J. / Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma : study design and rationale. In: Future Oncology. 2019 ; Vol. 15, No. 9. pp. 929-941.

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