A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma
Phase of Trial: Phase III
Latest Information Update: 19 Jan 2018
At a glance
- Drugs Melphalan (Primary) ; Dacarbazine; Ipilimumab; Pembrolizumab
- Indications Liver metastases; Uveal melanoma
- Focus Registrational; Therapeutic Use
- Acronyms FOCUS
- Sponsors Delcath Systems
- 10 Jan 2018 According to a Delcath Systems media release, the company has concluded a modification agreement with the U.S. Food and Drug Administration (FDA) for this trial to revise eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases. Modification will be now reviewed by the institutional review boards.
- 19 Dec 2017 According to a Delcath Systems media release, Data Safety Monitoring Board (DSMB) has completed its pre-specified review and has recommended to continue the study without any modification.
- 11 Nov 2016 According to Delcath media release, company has expanded this trial to include 10 new research centers in the U.S. and Europe.