PHP and Immunotherapy in Metastasized UM

Inclusion criteria

• ✓. Age between 18-75 yrs
• ✓. World Health Organization (WHO) Performance Status 0 or I
• ✓. 50% or less histologically or cytologically confirmed unresectable metastatic uveal melanoma in the parenchyma of the liver
• ✓. Hepatic metastases, confined to or predominantly in the liver
• ✓. No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab treatment, IL-2)
• ✓. Local pre-treatment of uveal melanoma metastases is allowed (resection and/or thermal ablation), except for chemotherapy containing procedures (e.g. chemoembolization) and radio-embolization, and as long as patients have progressed with measurable disease according to RECIST 1.1
• ✓. No concurrent systemic immunosuppressive medications ≥ 10mg/day prednisone or equivalent. Topical, inhaled, nasal and ophthalmic steroids, and adrenal replacement therapy are allowed.
• ✓. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, Creatinine ≤ 2x ULN, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH \< 2xULN

Exclusion criteria