MELANOMA: OCULAR MELANOMA: Metastatic: Hepatic dominant: Any line: "FOCUS"

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

Title
Delcath PHP=OCM-301 (FOCUS)
Study Title

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

Site Link
Malignancy
Melanoma, Ocular melanoma, hepatic metastases, skin
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Metastatic Any Line
Investigational Agent
Percutaneous hepatic perfusion of melphalan
Drug Class
Percutaneous hepatic perfusion
PI
Evan Glazer, MD
Sponsor
Delcath Systems Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically proven ocular melanoma to the liver
  • No more than 50% liver parenchema involvement
  • Evidence of limited extrahepatic disease allowed as long as life threatening component of disease is in liver
  • ECOG PS 0-1
  • No Child Class B or C cirrhosis
  • No active HBV or HCV
  • No active CNS mets
Objective

Primary: OS; Secondary: PFS, ORR

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Ocular melanoma
Dosing Frequency
Control Agents
Pembrolizumab
Study Protocol
Randomized
Yes
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