FusionVAC22_01: Fusion Transcript-based Peptide Vaccine and Atezolizumab

Trial snapshot

  • Formal name: FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined With Immune Checkpoint Inhibition (FusionVAC22)
  • Trial type: Specifically designed for fibrolamellar carcinoma
  • Phase: Phase I
  • Recruitment status: Active, Recruiting
  • Eligible ages: 18+
  • Location: Tübingen, Germany (University Hospital Tübingen and partner centers)
  • ClinicalTrials.gov ID: NCT05937295

Overview

This phase I clinical trial will evaluate the immunogenicity, safety, and first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) delivered in combination with the immune checkpoint inhibitor Atezolizumab (TecentriqTM). The study is expected to enroll 20 patients with fibrolamellar carcinoma or other cancers carrying the DNAJB1-PRKACA fusion transcript. It is being conducted by the network of Centers for Personalized Medicine (ZPM) at the University Hospitals of Freiburg, Heidelberg, Tübingen and Ulm in Baden-Württemberg, Germany. The initial Tübingen site is now open.

These researchers are looking into the viability of using a peptide immunization to give a patient’s immune system the ability to identify and destroy “foreign” FLC cells. The peptide vaccine, made from a fragment of the fusion region of FLC’s DNAJB1-PRKACA fusion protein, is being manufactured at the University Hospital Tübingen.

Trial eligibility

Enrollment in this trial is open to patients 18 years old and older whose disease has the confirmed presence of the DNAJB1-PRKACA fusion transcript.

Trial details

Participants will be required to visit the Tübingen study center once prior to beginning treatment. Blood will be drawn at the preliminary examination, and research participation eligibility will be determined. The Fusion-VAC-XS15 peptide vaccine will be administered to research participants at least twice during the course of the investigation. In addition, atezolizumab will be given intravenously as an infusion every four weeks. The course of treatment is set over one year.

Details about the study can be found on the University Hospital Tübingen web site (click here for a summary of the study in English) and at https://clinicaltrials.gov/study/NCT05937295. In addition, this linked article, published in Frontiers in Oncology in March 2024 provides more information about the study protocol.

Dr. Juliane Walz, an investigator for this trial, discusses the goals, rationale, design, and eligibility criteria for this clinical study in the video below:

Trial contact information:

Please visit clinicaltrials.gov for a comprehensive list of active trials. 

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