FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint In
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)
| Condition(s) | Fibrolamellar Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Ability to understand and willingness to sign a written informed consent document. * Histologically confirmed FL-HCC or other malignant disease that is locally advanced or metastatic. * Non-FL-HCC patients can be included * in case of disease progression after therapy and fulfilling at least one of the following criteria: i. no further standard therapy is available. ii. patient is considered unsuitable for further available standard therapy. iii. patient is unwilling to receive treatment with available standard therapy. * if no standard therapy exists. * Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-based next-generation sequencing (NGS) or realtime-polymerase chain reaction amplification (RT-PCR). * Age ≥18 years. * Eastern Cooperative Oncology Group ( |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital Tuebingen |
| Locations | Tübingen, Baden-Würtemberg, Germany |
| Start date | 2023-09-26 |
| NCT ID | NCT05937295 |
| Official listing | https://clinicaltrials.gov/study/NCT05937295 |