Inclusion criteria | |
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1. | Male or female aged above 18 years. |
2. | Signed and dated written informed consent before the start of specific protocol procedures. |
3. | Liver metastases measurable by magnetic resonance imaging (MRI, preferred) or a computational tomography (CT) scan of thorax and abdomen according to RECIST version 1.1 with at least one unidimensional measurable lesion ≥ 10 mm. The examination should be within four weeks prior to randomization. |
4. | ECOG performance status of 0 or 1. |
5. | No previous chemotherapy, radiotherapy, or biologic therapy for uveal melanoma metastases (first-line therapy) |
6. | 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 tumor. |
2. | Evidence of extrahepatic disease by PET-CT |
3. | Life expectancy of less than four 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 > =1.5 × ULN or creatinine clearance < 40 mL/min, calculated using the Cockroft and Gault formula. |
9. | Reduced blood leukocytes or platelets defined as LPK < 2.0 × 109/L and TPK <100 × 109/L |
10. | Use of live vaccines four weeks before or after the start of study. |
11. | Body mass index above 35. |