Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: Study design and rationale Journal Article
| Authors: | 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. |
| Article 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. © 2019 Future Medicine Ltd. |
| Keywords: | sunitinib; renal cell carcinoma; tyrosine kinase inhibitor; everolimus; first-line treatment; immuno-oncology; lenvatinib; pembrolizumab |
| Journal Title: | Future Oncology |
| Volume: | 15 |
| Issue: | 9 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2019-03-01 |
| Start Page: | 929 |
| End Page: | 941 |
| Language: | English |
| DOI: | 10.2217/fon-2018-0745 |
| PUBMED: | 30689402 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2019 -- Source: Scopus |
