This week, a new clinical trial of a peptide vaccine treated its first patient in Tübingen, Germany. The trial, named FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined With Immune Checkpoint Inhibition is expected to enroll 20 patients with fibrolamellar carcinoma or other cancers carrying the DNAJB1-PRKACA fusion transcript.
Study goals
This phase I study will examine the viability of using a peptide vaccine to provide a patient’s immune system the ability to identify and destroy FLC tumor cells. It will evaluate the safety and effectiveness of treating patients with a peptide vaccine (Fusion-VAC-XS15) in combination with the immune checkpoint inhibitor atezolizumab (TecentriqTM). The peptide vaccine, made from a fragment of FLC’s DNAJB1-PRKACA fusion protein, is being manufactured at the University Hospital Tübingen. “In our initial preclinical and clinical studies, we have been able to activate strong immune responses against the DNAJB1-PRKACA fusion peptide and have also already seen the first positive results in patients,” said Prof. Dr. Juliane Walz, whose department produced the peptide for the vaccine.
Previous application of FusionVAC-22-based peptide vaccines in two FLC patients was well tolerated without systemic side effects and a T-cell response was observed in both patients. A case study of the first FLC patient’s treatment by the research team was published in Nature Communications in October 2022 (click here to read the published article).
During this new clinical trial, patients will be treated with the immune checkpoint inhibitor atezolizumab, in addition to the vaccine. Immune checkpoint inhibitors (ICIs) are immunotherapy drugs that block proteins that stop the immune system from attacking the cancer cells. “By combining the peptide vaccine and immune checkpoint inhibitor, we hope to achieve an even better effect of the tumor vaccination,” said Prof. Dr. Michael Bitzer, one of the leaders of the study.
Eligibility and treatment overview
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.
Participants are 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.
Study locations
This clinical trial 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 Tübingen location is currently open and enrolling patients. The other locations will open soon.
More information
Additional 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. Patients and clinicians can also reach the study team via email at kketi@med.uni-tuebingen.de.