Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients

Exclusion Criteria

• •Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
• •Presence of known brain metastases. If patient is symptomatic, negative CT scan within two months before study beginning is required. However, presence of controlled brain metastases (i.e., evaluated as SD or PR after radiotherapy) is allowed.
• •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any cancer curatively treated ≥ 2 yeast prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours (TA, TIs \&TI).
• •History of chronic hepatitis B or C, or chronic active hepatitis or active autoimmune diseases.
• •History of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• •Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria).
• •Irreversible cardiac arrhythmias requiring permanent medication.
• •Uncontrolled hypertension.
• •Ischemic peripheral vascular disease (Grade IIb-IV).
• •Severe rheumatoid arthritis.
• •Severe diabetic retinopathy.
• •History of allograft or stem cell transplantation
• •Major trauma including surgery within 4 weeks of administration of study treatment.
• •Known history of allergy to IL2, gemcitabine, or other intravenously administered human proteins/peptides/antibodies.
• •Pregnancy or breast feeding. Female patient must agree to use effective contraception, or be surgically sterile or postmenopausal. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
• •Chemotherapy (standard or experimental) or radiation therapy within 4 weeks of the administration of study treatment.
• •Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment.
• •Growth factors or immunomodulatory agents within 7 days of the administration of study treatment.
• •Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. A maximum dose per day of 5 mg prednisone (or equivalent), when it is meant to address cancer symptoms (e.g., pain, dyspnoea, lack of appetite), is allowed. A suspected presence of chronic inflammatory disease has to be considered an exclusion criterion.
• •Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
• •Persons who are interned in Institutions by Judiciary or other Authorities