Trial snapshot
- Formal name: FusionVAC22_02: Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I
- Recruitment status: Active, Recruiting
- Eligible ages: 18+
- Location: Tübingen, Germany (University Hospital Tübingen)
- ClinicalTrials.gov ID: NCT06789198
Overview
This phase I study will assess the safety and efficacy of a peptide vaccine (Fusion-VAC-XS15) against FLC’s driver protein as an “adjuvant” therapy in FLC patients who, after surgery and/or other treatment, are free of cancer as judged by radiological scans. The goal is to significantly delay or entirely prevent the return of the cancer. The vaccine will be given alone, without additional immunotherapy or any other systemic agent.
Recurrence rates of FLC after successful surgery, liver transplantation, or systemic therapy are quite high. A recent case report documented disease recurrence in a fibrolamellar patient nearly two decades after the apparently successful resection of the initial tumor. In this trial, the study team hopes to use a peptide vaccine to activate the immune system against any remaining tumor cells and enable long-term disease-free survival.
Trial eligibility
Enrollment in this trial will be open to patients whose disease has the confirmed presence of the DNAJB1-PRKACA fusion transcript and who have achieved complete remission (CR) status according to RECIST1.1. Initially all patients must be 18 years old or older. Patients 12 years and older will be eligible to participate after 6 adult patients have been enrolled in the study.
Trial details
During the trial, the FusionVAC-22 peptide will be administered subcutaneously. A total of two vaccinations are planned for each patient, delivered 4 weeks apart. If an insufficient T cell response is detected after the two-vaccine treatment, a booster vaccination can be applied.
Details about the study can be found on the University Hospital Tübingen web site and at https://clinicaltrials.gov/study/NCT06789198.
In the video below, Dr. Juliane Walz discusses the goals and design for this clinical study, as well as the differences between the two peptide vaccine trials currently underway in Tübingen, Germany:
Trial contact information:
- Juliane Walz, Prof. Dr. – kketi@med.uni-tuebingen.de
Please visit clinicaltrials.gov for a comprehensive list of active trials.
The Fibrolamellar Cancer Foundation does not provide medical advice. We provide website users with information to help them better understand their health conditions and current approaches towards diagnosis, treatment and supportive care. Always seek the advice of your physician or other qualified healthcare provider.