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

共 50 条

[41] Independent assessment of lenvatinib plus everolimus in patients with metastatic renal cell carcinoma
Motzer, Robert J.
Hutson, Thomas E.
Ren, Min
Dutcus, Corina
Larkin, James
[J]. LANCET ONCOLOGY, 2016, 17 (01): : E4 - E5
[42] Lenvatinib plus pembrolizumab in patients with renal cell carcinoma: Updated results.
Lee, Chung-Han
Makker, Vicky
Rasco, Drew W.
Taylor, Matthew H.
Stepan, Daniel E.
Shumaker, Robert Charles
Schmidt, Emmett V.
Guo, Matthew
Dutcus, Corina E.
Motzer, Robert J.
[J]. JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)
[43] Sunitinib versus everolimus for non-clear-cell renal cell carcinoma
Rebecca Kelsey
[J]. Nature Reviews Urology, 2016, 13 (3) : 124 - 124
[44] Cost-effectiveness Analysis of Pembrolizumab Plus Axitinib Versus Sunitinib in First-line Advanced Renal Cell Carcinoma in China
Jun Chen
Gaoyun Hu
Zhuo Chen
Xiaomin Wan
Chongqing Tan
Xiaohui Zeng
Zeneng Cheng
[J]. Clinical Drug Investigation, 2019, 39 : 931 - 938
[45] A COST-EFFCTIVENESS ANALYSIS OF PEMBROLIZUMAB PLUS AXITINIB VERSUS SUNITINIB FOR FIRST-LINE TREATMENT OF ADVANCED RENAL CELL CARCINOMA
Gu, J.
[J]. VALUE IN HEALTH, 2020, 23 : S32 - S32
[46] Cost-effectiveness Analysis of Pembrolizumab Plus Axitinib Versus Sunitinib in First-line Advanced Renal Cell Carcinoma in China
Chen, Jun
Hu, Gaoyun
Chen, Zhuo
Wan, Xiaomin
Tan, Chongqing
Zeng, Xiaohui
Cheng, Zeneng
[J]. CLINICAL DRUG INVESTIGATION, 2019, 39 (10) : 931 - 938
[47] Lenvatinib in combination with everolimus in patients with advanced or metastatic renal cell carcinoma: A phase 1 study
Matsubara, Nobuaki
Naito, Yoichi
Nakano, Kenji
Fujiwara, Yutaka
Ikezawa, Hiroki
Yusa, Wataru
Namiki, Masayuki
Okude, Takashi
Takahashi, Shunji
[J]. INTERNATIONAL JOURNAL OF UROLOGY, 2018, 25 (11) : 922 - 928
[48] Lenvatinib plus pembrolizumab for untreated advanced renal cell carcinoma: a systematic review and cost-effectiveness analysis
Fleeman, Nigel
Houten, Rachel
Nevitt, Sarah
Mahon, James
Beale, Sophie
Boland, Angela
Greenhalgh, Janette
Edwards, Katherine
Maden, Michelle
Bhattacharyya, Devarshi
Chaplin, Marty
McEntee, Joanne
Chow, Shien
Waddell, Tom
[J]. HEALTH TECHNOLOGY ASSESSMENT, 2024, 28 (49)
[49] KEYTRUDA® (Pembrolizumab) plus KISPLYX® (Lenvatinib) - First-Line Treatment of Patients with advanced Renal Cell Carcinoma
不详
[J]. ONCOLOGY RESEARCH AND TREATMENT, 2021, 44 (1-2) : 70 - 70
[50] Lenvatinib plus Everolimus in advanced Renal Cell Carcinoma New effective Second Line Therapy-Option
Gunther, Jeannine
[J]. ONCOLOGY RESEARCH AND TREATMENT, 2017, 40 (04) : 229 - 229

← 1 2 3 4 5 →