The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases

Inclusion Criteria:

1. Male or female aged above 18 years.
2. Signed and dated written informed consent before the start of specific protocol procedures.
3. Histologically or cytologically proven liver metastases of uveal melanoma. If this is not possible at the time of randomization, a biopsy is mandatory before start of treatment.
4. Liver metastases measurable by MRI (preferred) or CT of thorax and abdomen according to RECIST version 1.1 with at least one unidimensional measurable lesion ≥ 10 mm. The examination should be within 4 weeks prior to randomization.
5. ECOG performance status of 0 or 1.
6. No previous chemotherapy, radiotherapy, or biologic therapy for uveal melanoma metastases (ie first-line therapy)
7. Adequate hepatic function (defined as ASAT,ALAT, bilirubin \<= 3\*ULN and PK-INR \<= 1.5) and no medical history of liver cirrhosis or portal hypertension

Exclusion Criteria:

1. More than 50% of the liver volume (measured by CT or MRI) replaced by tumour.
2. Evidence of extrahepatic disease by PET-CT
3. Life expectancy of less than 4 months
4. Pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
5. Active infection.
6. Ischemic cardiac disease or history of congestive heart failure with an LVEF \< 40%.
7. COPD or other chronic pulmonary disease with PFT's indicating an FEV\< 50% predicted for age.
8. Reduced renal function defined as S-Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockroft and Gault formula.
9. Reduced blood leukocytes or platelets defined as LPK \< 2.0x109/L and TPK \<100x109/L
10. Use of live vaccines four weeks before or after the start of study.
11. Body mass index above 35.