West Cancer Center

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

NCT02678572

Malignancy

Melanoma, Ocular melanoma, hepatic metastases, skin

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Metastatic Any Line

Investigational Agent

Percutaneous hepatic perfusion of melphalan

Drug Class

Percutaneous hepatic perfusion

Evan Glazer, MD

Sponsor

Delcath Systems Inc.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/study/NCT02678572

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

Assessment Frequency Link

Path

Ocular melanoma

Dosing Frequency

Control Agents

Pembrolizumab

Study Protocol

Randomized

Yes