Vorolanib (Cm082), Everolimus, And The Combination In Patients With Pretreated Metastatic Renal Cell Carcinoma (Concept Study): A Randomized, Phase 2/3, Double-Blind, Multi-Center Trial.

TPS4605Background: VEGF and mTOR pathways play key role in the development of renal cell carcinoma (RCC), the combination of agents targeting both VEGF- and mTOR-mediated pathways have been investigated with distinct results. Vorolanib (CM082) is a potent and selective inhibitor of VEGFR and PDGFR. Previous phase 1 study (NCT02577458) found that the combination of vorolanib 200 mg plus everolimus 5mg was associated with manageable toxicity consistent with individual agents and no new safety signals, antitumor activities was also seen in 35.7% patients with RCC patients who progressed on at least one VEGFR TKI therapy. Based on these findings, we conducted the CONCEPT study, a randomized, phase 2/3, double-bind, multicenter trial to assess vorolanib, everolimus, or their combination as second-line treatment in Chinese patients with metastatic RCC. Methods: Patients with cytologically or histologically confirmed RCC who had disease progression after one prior VEGFR TKI were eligible for participation in the...