AVEO Oncology has enrolled and dosed the first patient in a pivotal phase 3 clinical trial, TIVO-3, to compare tivozanib with sorafenib in people with advanced renal cell carcinoma (RCC) that has stopped responding to treatment. Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
TIVO-3 is a randomised, controlled, multi-centre, open-label study being conducted in the US, Belgium and Italy. TIVO-3 plans to recruit approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior drug treatments, including VEGFR-TKI therapy (other than sorafenib) and/or checkpoint inhibitor therapy. Patients will be randomised to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. First results from the study are currently projected for the first quarter of 2018.