Phase 1 trial of everolimus plus sunitinib in patients with metastatic renal cell carcinoma.

Background: Simultaneous inhibition of the vascular epithelial growth factor (VEGF) and the mammalian target of rapamycin (mTOR) pathway may improve treatment response in advanced renal cell carcinoma (RCC). Everolimus, an oral mTOR inhibitor, and sunitinib, an oral tyrosine kinase inhibitor targeting VEGF, are standard agents in the management of metastatic RCC.

Methods: Sequential cohorts of 3 to 6 patients with advanced RCC received dose-escalated combinations of sunitinib (37.