Phase 3 FOCUS Trial in Hepatic Dominant Ocular Melanoma
A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma
Our Phase 3 FOCUS Trial is evaluating the efficacy, safety and pharmacokinetics of Melphalan/HDS versus best alternative care in 240 patients with ocular melanoma. The primary objective of the study is a comparison of overall survival between the Melphalan/HDS treatment arm and best alternative care comprised of selected therapies; secondary objectives include overall progression-free survival and objective response rate, each as determined by the Investigator, while exploratory objectives include progression-free survival, objective response rate, hepatic progression free survival and hepatic objective response rate all as determined by Independent Central Review, and quality of life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.
Delcath does not make any claim whatsoever, real or implied, about the efficacy or safety of any therapy, drug, system, or technique under active research.