At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed fibrolamellar HCC or other malignant disease that is locally advanced or metastatic
- ✓DNAJB1-PRKACA fusion transcript by RNA-based NGS or RT-PCR
- ✓Age 18 years or older
- ✓ECOG performance status 0 or 1
- ✕Pregnant or breastfeeding
- ✕Unwilling or unable to follow study schedule
- ✕Chemotherapy, systemic therapy, or radiotherapy within 14 days prior to first dose
- ✕Concurrent or previous treatment within 30 days in another interventional clinical trial with investigational anticancer or other investigational therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
FusionVAC22_01: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition for Fibrolamellar Hepatocellular Carcinoma and Other Tumor Entities Carrying the Oncogenic Driver Fusion
In Brief
A Phase 1 clinical trial evaluating Fusion-VAC-XS15 for Fibrolamellar Hepatocellular Carcinoma. Currently recruiting, targeting 20 participants across 1 site.
Detailed Summary
The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in combination with anti-programmed cell death-ligand 1 immune checkpoint inhibition (ICI) by Atezolizumab (TecentriqTM) in patients with Fibrolamellar hepatocellular carcinoma (FL-HCC) or other cancer entities carrying the DNAJB1-PRKACA fusion transcript.
Study Details
Timeline
Interventions
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.