FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 26, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

January 31, 2027

Conditions
Fibrolamellar Hepatocellular Carcinoma
Interventions
DRUG

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."

Trial Locations (1)

72076

RECRUITING

University Hospital Tuebingen, Tübingen

All Listed Sponsors
lead

University Hospital Tuebingen

OTHER