1. To assess immunogenicity in terms of induction of peptide specific T-cell responses (Time Frame - through study completion, an average of 1 year): The percentage of patients with an induction of T-cell response until 28 days after second vaccination will be the primary endpoint for efficacy. Peptide stimulated Peripheral Blood Mononuclear Cells (PBMCs) are analyzed by enzyme-linked immunospot (ELISPOT).
2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the peptide vaccine in combination with anti-PD-L1 immune checkpoint inhibition (Time Frame - through study completion, an average of 1 year): The safety and toxicity of the personalized multi-peptide vaccine in combination with the toll-like receptor1/2 ligand XS15 with anti-PD-L1 immune checkpoint inhibition (ICI) will be determined based on the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and assessed in a descriptive manner.
Fusion-VAC-XS15: FusionVAC-22 peptide will be administered subcutaneously (s.c.) adjuvanted with the Toll-like receptor 1/2 ligand XS15 (50 μg) emulsified in Montanide ISA 51 VG (1:1).
Vaccination will take place every 4 weeks at the beginning of Cycle 1 and 2. A total of two vaccinations are planned.
After 11 months a booster vaccination can be applied depending on T-cell responses.
Immune checkpoint inhibition (ICI):
Atezolizumab (TecentriqTM, Roche Pharma AG) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that targets PD-L1 and will be applied intravenously (i.v.).
The anti-PD-L1 antibody Atezolizumab (TecentriqTM) 1680 mg will be applied every 4 weeks as a 30-minute infusion (60-minute first dose) starting on day 15 after the first vaccination. Anti-PD-L1 treatment will be continued after the end of vaccination phase throughout the complete study period until End of Treatment (EOT) or until disease progression or other reasons for study termination.
Quelle: ClinicalTrials.gov
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"FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined With Immune Checkpoint Inhibition"
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