TEIPP Immunotherapy in Patients With NSCLC

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

In this multicenter, open label non-randomized phase I/II dose escalation study with extension cohort HLA-A*0201-positive patients with non small cell lung cancer (NSCLC) can be included. The primary aim of this study is determine the safety, tolerability and immune modulating effects of the therapeutic LRPAP1 synthetic long peptide (LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses. Secondary objectives are to assess the specificity and immune modulatory effects of the vaccine, to assess the antigen and immune status of the patients, and to determine progression free survival (PFS), overall survival (OS), and the radiological tumor response up to one year after first vaccination.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Monatide (IMS 3015); Pembrolizumab

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 ≤ 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) .

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.