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 medaffairs@delcath.com 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