TEIPP Immunotherapy in Patients With NSCLC

Korábbi kezelés

• Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6 weeks interval.
• Concomitant participation in another clinical intervention trial (except participation in a biobank study).
• Patients with a currently active second malignancy. However, patients with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of prostate cancer.

Más betegség

• Active infection, including hepatitis B or C or HIV infection that is uncontrolled at inclusion. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed.
• Known allergy to any of the ingredients of the vaccine (peptide, Montanide ISA-51, trifluoroacetic acid, acetonitrile, dichloromethane, dimethylsulfoxide).
• Any medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or participate in the study
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Egyéb

• Pregnant or lactating women.

• Age >18 years
• Pathologically and radiologically confirmed advanced NSCLC.
• Progression after minimally 4 cycles of combination platinum containing chemotherapy and immunotherapy (PD1), or after 4 cycles of platinum containing chemotherapy and immunotherapy (PD-1) followed by maintenance chemo immunotherapy
• HLA-A*0201 positive
• An expected survival of at least 3 months
• WHO/ECOG performance status ≤ 2 (Appendix 3)
• Adequate renal function as defined by creatinine clearance > 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR)
• Adequate hepatic function as evidenced by
  • Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless considered due to hepatic metastases
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to hepatic metastases
• Ability to return to the hospital for adequate follow-up as required by this protocol.
• Written informed consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) .