Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma

Inclusion Criteria: 1. Male or non-pregnant, non-breast feeding female; 2. Aged between 18 and 75 years; 3. Stage IIIB, stage IIIC or stage IV melanoma with: * At least 2 cutaneous or subcutaneous non necrotic accessible tumours; * Tumour size of 1 to 1.5 cm diameter; * No minimum distance between the 2 selected lesions; 4. Progressive melanoma not responding to previous treatments or patients refusing other therapies; 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 6. For women of child-bearing age: effective contraception method (oral contraception or intra-uterine device) used for more than 2 months before the 1st administration and to be maintained for 3 months after the last administration of Plasmid AMEP; 7. Having given a written informed consent. Exclusion Criteria: 1. Patients who can benefit from other melanoma treatments including surgery; 2. Significant cardiac arrhythmias, electronic pacemakers, defibrillators, or any implanted electronic device; 3. Recent (less than 6 months) acute vascular diseases (stroke, MI…); 4. Advanced peripheral arterial diseases, venous ulcers, or scleroderma; 5. History or treatment of seizures within the last 5 years; 6. Clinically significant abnormality at pre-study full physical examination; 7. Any clinically significant ECG abnormalities; 8. Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, radiotherapy or surgery unrelated to the fields in question are allowed; 9. Abnormal renal function (creatinine plasma level \> ULN); 10. Abnormal liver function tests (any of the following): * PT \< 70%, ASAT, ALAT, alkaline phosphatases, GGT and/or total bilirubin \> ULN in the absence of liver metastasis; * PT \< 70%, ASAT, ALAT \> 2 ULN, alkaline phosphatases \> 1.5 ULN, GGT \> 5 ULN and/or total bilirubin \> 3 ULN in the case of liver metastases; 11. Abnormal bone marrow function: haemoglobin \< 10g/dL, WBC \< 3.109 /L and/or platelet count \< 100.103 /L; 12. Clinically significant abnormality in pre-study laboratory tests; 13. Evidence of significant active infection (e.g., pneumonia, wound abscess, etc); 14. Intractable coagulopathy; 15. Any significant disease, including psychiatric and dermatology diseases that may affect the proper evaluation of efficacy or safety; 16. Patients who had participated in another clinical trial in the last 30 days prior to enrolment in the present clinical trial; 17. Patients unwilling or unable to comply with protocol requirements and scheduled visits. Note: patients with brain metastases, or waiting for other therapies (i.e. isolated limb perfusion) may be included.