Liver-directed treatment with melphalan/HDS is available through the Expanded Access Program at leading cancer centers in the United States.

To find out more, email or call +1 917.902.6455

Expanded Access Program: Percutaneous hepatic perfusion (PHP) with melphalan/HDS for patients with hepatic-dominant metastatic ocular melanoma

Key Objectives

  • To provide access to melphalan/HDS for patients with hepatic-dominant metastatic ocular melanoma
  • To evaluate the safety of treatment with melphalan/HDS

Key Inclusion Criteria

  • 50% or less ocular melanoma metastases in the liver
  • Liver disease must be measurable by CT and/or MRI
  • Evidence of limited extrahepatic disease at baseline is acceptable if the life-threatening component of progressive disease is in the liver
  • ECOG PS of 0-1 at screening
  • Prior chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization is allowed with a washout period
  • Patients receiving anti–PD-1 immunotherapy such as pembrolizumab or nivolumab, or anti–CTLA-4 immunotherapy such as ipilimumab should wait 8 weeks before receiving PHP treatment

Key Exclusion Criteria


  • Patients with notable cirrhosis or with evidence of portal hypertension
  • Cardiac conditions preventing the use of general anesthesia
  • Clinically significant pulmonary disease that prevents the use of general anesthesia
  • Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anticoagulation therapy
  • Patients with active bacterial infections with systemic manifestations (malaise, fever, leukocytosis) are not eligible until completion of appropriate therapy
CT, computed tomography; CTLA, cytotoxic T-lymphocyte–associated protein; ECOG PS, Eastern Cooperative Oncology Group performance status; HDS, hepatic delivery system; MRI, magnetic resonance imaging; PD-1, programmed cell death protein 1