This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\*02:01-positive patients.
Patient is ≥18 years of age on the day of signing informed consent.
ECOG performance status of 0 or 1.
Histologically or cytologically confirmed liver metastasis of uveal melanoma.
HLA-A*02:01 positive status.
Life expectancy of less than 6 months.
More than 50% of the liver volume replaced by tumor as measured by MRI.
Extrahepatic disease as measured by CT of thorax abdomen and pelvis. (See inclusion criteria #10 above for limited treatable extrahepatic disease.)
History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Delcath Systems Inc.
Collaborator