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

被引：33

作者：

Grunwald, Viktor ^{[1
]}

Powles, Thomas ^{[2
]}

Choueiri, Toni K. ^{[3
]}

Hutson, Thomas E. ^{[4
]}

Porta, Camillo ^{[5
,6
]}

Eto, Masatoshi ^{[7
]}

Sternberg, Cora N. ^{[8
]}

Rha, Sun Young ^{[9
]}

He, Cixin S. ^{[10
]}

Dutcus, Corina E. ^{[10
]}

Smith, Alan ^{[10
]}

Dutta, Lea ^{[10
]}

Mody, Kalgi ^{[10
]}

Motzer, Robert J. ^{[11
]}

机构：

[1] Univ Hosp Essen, Clin Hematol Hemostasis Oncol & Stem Cell Transpl, Essen, Germany

[2] Barts Canc Inst, Expt Canc Med, London, England

[3] Dana Farber Canc Inst, Lank Ctr Genitourinary Oncol, Boston, MA 02115 USA

[4] Baylor Univ, Med Ctr, Urol Oncol Program, Dallas, TX USA

[5] Univ Pavia, Pavia, Italy

[6] IRCCS Ist Clin Sci Maugeri, Div Translat Oncol, Pavia, Italy

[7] Kyushu Univ, Dept Urol, Fukuoka, Fukuoka, Japan

[8] New York Presbyterian, Weill Cornell Med, New York, NY USA

[9] Yonsei Univ, Yonsei Canc Ctr, Coll Med, Seoul, South Korea

[10] Eisai Inc, Woodcliff Lake, NJ USA

[11] Mem Sloan Kettering Canc Ctr, Dept Med, 1275 York Ave, New York, NY 10021 USA

来源：

FUTURE ONCOLOGY | 2019年 / 15卷 / 09期

关键词：

everolimus; first-line treatment; immuno-oncology; lenvatinib; pembrolizumab; renal cell carcinoma; sunitinib; tyrosine kinase inhibitor; ENDOTHELIAL GROWTH-FACTOR; TYROSINE KINASE INHIBITOR; ANTITUMOR ACTIVITIES; TARGETED THERAPY; MTOR INHIBITORS; CLINICAL-TRIAL; PHASE-II; COMBINATION; E7080; BEVACIZUMAB;

D O I：

10.2217/fon-2018-0745

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：929 / 941

页数：13

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