Electroporation Potentiated Immunotherapy in Cancer

Exclusion Criteria

• •1. Underlying medical disease not adequately treated (e.g. poorly regulated diabetes and symptomatic cardiac disease)
• •2. Prior or current autoimmune disorder with risk of serious toxicity during treatment with checkpoint inhibitor
• •3. Acute myocardial infarction, cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months from start of treatment
• •4. Previous reception of allogeneic stem cells or solid organ donation
• •5. Active infection requiring systemic therapy within 7 days prior to treatment initiation
• •6. Positive HIV, HBV, and HCV test results (prior testing or new testing in patients at risk)
• •7. Active psychiatric disease or history of drug or alcohol abuse affecting participation
• •8. Allergy to active substance or any of the auxiliary agents, including known severe allergy to anesthetic agent, paralytic agent or any of the equipment used during treatment
• •9. Expected need for systemic corticosteroid or other systemic immunosuppressive drug during the course of this clinical trial. A low dose of e.g. prednisone ≤ 10 mg/day is permitted for maximally 7 consecutive days
• •10. Coexisting malignant disease, except non-melanoma skin cancer
• •11. Symptomatic or untreated CNS metastases
• •12. Liver cirrhosis Child Pugh \>A
• •13. Pregnant or breast-feeding patients. For women of childbearing potential, a negative pregnancy test (minimum sensitivity 25mIU(hCG)/ml) is mandatory prior to inclusion and every month during the trial
• •14. Women of childbearing potential not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment. Male patients with a fertile partner are also required to secure effective methods of contraception (definition available in protocol)
• •15. Previous immunotherapy
• •16. Patients referred from a hospital outside of Denmark
• •17. Major dilation of veins or bowel obstructing the needle path
• •18. Persistent atrial fibrillation
• •19. Metal objects (e.g. biliary SEMS) within 5 cm of ablation target
• •20. Cardiac pacemaker or ICD, that cannot be safely disconnected during IRE treatment