A study to detect the effect of radiofrequent ablation in combination with ipilimumab in patients with eye melanoma that spread out to the liver.

Changed 8-jun-2015:
1. Adults at least 18 years of age;

2. World Health Organization (WHO) Performance Status 0 or I;

3. Histologically or cytologically confirmed unresectable metastatic uveal melanoma (as confirmed by multidisciplinary opinion, including liver surgeon);

4. Subjects must have at least two liver metastases (both > 1 cm in diameter) and one of them feasible for RFA

5. No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab-treatment, IL-2);

6. Local pretreatment of uveal melanoma metastases is allowed, except for chemotherapy containing procedures (e.g. chemoembolisation), and as long patients have progresses with at least two measurable lesions now;

7. No concurrent immunosuppressive medications (including dexamethason, prednisolon, azathioprin);

8. Screening laboratory values must meet the following criteria: WBC ¡Ý 2.0x109/L, Neutrophils ¡Ý1.0x109/L, Platelets ¡Ý100 x109/L, Hemoglobin ¡Ý5.5 mmol/L, Creatinine ¡Ü2x ULN, AST ¡Ü 5 x ULN, ALT ¡Ü5 x ULN, Total bilirubin ¡Ü3 X ULN, INR and PTT in normal range, LDH ¡Ü 2x ULN;

9. Women of child bearing potential (WOCBP) must agree to use a reliable form of contraceptive during the study treatment period and for at least 180 days following the last dose of study drug;

10. Men must agree to the use of male contraception during the study treatment period and for at least 180 days after the last dose of study drug;

11. Absence of additional severe and/or uncontrolled concurrent disease;

12. No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease free for > 2 years.

1. Cerebral or meningeal metastasized uveal melanoma;

2. Subjects with any active autoimmune disease or a documented history of
autoimmune disease, or history of syndrome that required systemic steroids or
immunosuppressive medications, except for subjects with vitiligo or resolved
childhood asthma/atopy;

3. Prior immunotherapy (tumor vaccine, cytokine, or growth factor);

4. Known history of infection with Human Immunodeficiency Virus;

5. Active infection requiring therapy, positive serology for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA);

6. Underlying medical conditions that, in the Investigator's opinion, will make the
administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events;

7. Concurrent medical condition requiring the use of immunosuppressive
medications, or immunosuppressive doses of systemic or absorbable topical
corticosteroids;

8. History of or current immunodeficiency disease, splenectomy or splenic irradiation;
Prior allogeneic stem cell transplantation;

9. Use of other investigational drugs before study drug administration for systemic
malignancy;

10. Pregnancy or nursing.