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 | |
| Publication status | Published - 2019 Mar |
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All Science Journal Classification (ASJC) codes
- Oncology
- Cancer Research
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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
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
Y1 - 2019/3
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
C2 - 30689402
AN - SCOPUS:85063201714
VL - 15
SP - 929
EP - 941
JO - Future Oncology
JF - Future Oncology
SN - 1479-6694
IS - 9
ER -