A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

Trial Profile

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

Recruiting
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
  • Most Recent Events

    • 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.
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