lung cancer non-small cell lung cancer
Conditions
Interventions
Patients will receive an off the shelf TEIPP24 vaccine mixed with Montanide
ISA-51 adjuvant, which will be admistered every three weeks for a period of
three rounds of vaccination. The TEIPP24 vacci
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 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 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) - Adequate hepatic function as evidenced by o Serum total bilirubin
Exclusion criteria
Exclusion criteria: - 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. - 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). - Pregnant or lactating women. - 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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be determined by the incidence rate at each dose level based on the following safety parameters: adverse drug reactions and serious ADRs, changes in haematology and chemistry values, including those associated with hepatic and renal function, and assessment of physical examinations, vital signs and performance status. NCI-CTCAE version 5.0 will be used. TEIPP-specific immunity: HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell reactivity will be determined by measuring the magnitude and function of HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell present in the blood and/or tumor samples before and after TEIPP24 vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary enpoints: - The specificity and immune modulatory effects of the vaccine. - The antigen and immune status of the patients. - The progression free survival (PFS) and overall survival (OS) up to one year after first vaccination. - The radiological tumor response and tumor response duration up to one year after first vaccination according to RECIST v.1.1 criteria. | — |
Countries
Netherlands
Outcome results
None listed