Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

Exclusion Criteria

• •1. Life expectancy of less than 3 months.
• •2. History of interstitial lung disease (ILD) or (non-infectious) pneumonitis.
• •3. Reduced renal function defined as S- Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockroft and Gault formula.
• •4. Reduced hepatic function (defined as ASAT, ALAT, bilirubin \> 3\*ULN and PK- INR \> 1.5) or medical history of liver cirrhosis or portal hypertension.
• •5. Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L
• •6. Use of live vaccines four weeks before or after the start of study.
• •7. History of severe hypersensitivity reactions to monoclonal antibodies.
• •8. Active infection.
• •9. Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
• •10. Active autoimmune disease or a history of known or suspected autoimmune disease.
• •11. A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• •12. Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
• •13. Has a known additional malignancy of other diagnosis that is progressing or requires active treatment.
• •14. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
• •15. A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.