The latest clinical trial protocol published in Future Oncology describes the design and rationale of a Phase III trial designed to evaluate whether a combination of two targeted therapies (lenvatinib plus everolimus), or the combination of a single targeted therapy and a PD-1 inhibitor (lenvatinib plus pembrolizumab), would be superior to the standard therapy (sunitinib) for advanced or metastatic renal cell carcinoma patients (RCC). Find out more in the full paper available below.
Aims: Lenvatinib plus everolimus is approved for the treatment of RCC after 1 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 3-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. ClinicalTrials.gov NCT02811861.