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 journalArticle

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 - Mar 1 2019

Fingerprint

Renal Cell Carcinoma
Therapeutics
Vascular Endothelial Growth Factor A
Disease-Free Survival
Survival Rate
Pharmacokinetics
Biomarkers
Quality of Life
Safety
lenvatinib
Everolimus
sunitinib
pembrolizumab

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

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, 01.03.2019, p. 929-941.

Research output: Contribution to journalArticle

Grünwald, V, Powles, T, Choueiri, TK, Hutson, TE, Porta, C, Eto, M, Sternberg, CN, Rha, SY, He, CS, Dutcus, CE, Smith, A, Dutta, L, Mody, K & Motzer, RJ 2019, 'Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: Study design and rationale', Future Oncology, vol. 15, no. 9, pp. 929-941. https://doi.org/10.2217/fon-2018-0745
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.
@article{000442863cfa42c2b98b844dec98deb0,
title = "Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: Study design and rationale",
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.",
author = "Viktor Gr{\"u}nwald and Thomas Powles and Choueiri, {Toni K.} and Hutson, {Thomas E.} and Camillo Porta and Masatoshi Eto and Sternberg, {Cora N.} and Rha, {Sun Young} and He, {Cixin S.} and Dutcus, {Corina E.} and Alan Smith and Lea Dutta and Kalgi Mody and Motzer, {Robert J.}",
year = "2019",
month = "3",
day = "1",
doi = "10.2217/fon-2018-0745",
language = "English",
volume = "15",
pages = "929--941",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "9",

}

TY - JOUR

T1 - Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma

T2 - Study design and rationale

AU - Grünwald, Viktor

AU - Powles, Thomas

AU - Choueiri, Toni K.

AU - Hutson, Thomas E.

AU - Porta, Camillo

AU - Eto, Masatoshi

AU - Sternberg, Cora N.

AU - Rha, Sun Young

AU - He, Cixin S.

AU - Dutcus, Corina E.

AU - Smith, Alan

AU - Dutta, Lea

AU - Mody, Kalgi

AU - Motzer, Robert J.

PY - 2019/3/1

Y1 - 2019/3/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85063201714&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063201714&partnerID=8YFLogxK

U2 - 10.2217/fon-2018-0745

DO - 10.2217/fon-2018-0745

M3 - Article

VL - 15

SP - 929

EP - 941

JO - Future Oncology

JF - Future Oncology

SN - 1479-6694

IS - 9

ER -