A Study on the Safety and Immunogenicity of Combined Intradermal and Intravenous Administration of an Autologous mRNA Electroporated Dendritic Cell Vaccine in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Exclusion Criteria

• •1. Evidence of immunodeficiency. Autoimmune disease requiring medical treatment
• •2. Any serious acute or chronic illnesses or other conditions requiring concurrent medications not allowed during this study.
• •3. History of malignancy.
• •4. Inability to undergo PET/CT or MRI examination.
• •5. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• •6. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
• •7. Subject is pregnant or is currently breast-feeding, anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessary, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
• •8. Current alcohol dependence or drug abuse.
• •9. Known hypersensitivity to the study treatment.
• •10. Legal incapacity or limited legal capacity.
• •11. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• •12. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.