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.
- Antibodies, Monoclonal, Humanized/pharmacokinetics
- Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics
- Biomarkers, Tumor/analysis
- Carcinoma, Renal Cell/drug therapy
- Clinical Trials, Phase III as Topic
- Kidney Neoplasms/drug therapy
- Multicenter Studies as Topic
- Phenylurea Compounds/pharmacokinetics
- Progression-Free Survival
- Quality of Life
- Randomized Controlled Trials as Topic
- Survival Analysis
- Young Adult