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A Single-Arm, Multicenter, Phase 2 Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination with Everolimus in Subjects with Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received any Chemotherapy for Advanced Disease
The purpose of the study is to evaluate the effectiveness (how well they work) and the safety of the study drugs, the combination of lenvatinib and everolimus, in participants with unresectable (not able to be removed by surgery) advanced or metastatic (spread from one organ to another) non clear cell renal carcinoma (nccRCC) (a specific type of kidney cancer) who have not received any chemotherapy for advanced disease.
Primary Objective: - To evaluate objective response rate (ORR) of lenvatinib in combination with everolimus in subjects with unresectable advanced or metastatic non clear cell renal cell carcinoma(nccRCC) who have not received any chemotherapy for advanced disease. Secondary Objectives: - To assess safety and tolerability of lenvatinib in combination with everolimus. - To evaluate progression-free survival (PFS). - To evaluate overall survival (OS). - To assess the pharmacokinetic (PK) profiles of lenvatinib and everolimus during combination therapy in subjects with nccRCC. Exploratory Objectives: - To explore clinical benefit rate (CBR). - To explore disease control rate (DCR). - To explore duration of response (DOR). - To identify and explore tumor and blood biomarkers that correlate with clinical outcomes, including efficacy. - To explore the relationship of population PK derived exposure parameters to biomarker, safety, and efficacy data using a model-based approach.