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Study of DNAJB1-PRKACA Peptide Vaccine for Patients with Fibrolamellar Hepatocellular Carcinoma and Other Tumors with Oncogenic Driver Fusion

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of liver cancer called fibrolamellar hepatocellular carcinoma and other tumors that have a specific genetic change known as the DNAJB1-PRKACA fusion. The treatment being tested is a new vaccine called Fusion-VAC-XS15, which is designed to help the immune system recognize and fight these cancer cells.

The purpose of the study is to evaluate how well the vaccine works in stimulating the immune system, as well as to assess its safety and any potential side effects. Participants in the study will receive the vaccine through an injection under the skin. The study will monitor the participants over time to see how their immune systems respond to the vaccine and to check for any side effects. Some participants may receive additional doses of the vaccine, known as booster shots, to help maintain the immune response.

Throughout the study, researchers will collect information on how the vaccine affects the participants' health, including any changes in their cancer status and overall quality of life. The study aims to provide valuable insights into the potential benefits of the Fusion-VAC-XS15 vaccine for patients with these specific types of cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial vaccination

    The trial begins with the administration of the Fusion-VAC-XS15 vaccine. This is an emulsion for injection given through subcutaneous use.

    The vaccine is designed to target specific cancer types, including fibrolamellar hepatocellular carcinoma and other tumors with a specific genetic marker.

  2. Step 2

    Monitoring and follow-up

    After the initial vaccination, regular follow-up visits are scheduled to monitor the body's response to the vaccine.

    These visits include assessments of the immune response, specifically the induction of peptide-specific T-cell responses, and evaluations of safety and any side effects.

  3. Step 3

    Booster vaccinations

    Depending on the initial response, booster vaccinations may be administered to enhance the immune response.

    The decision to provide booster vaccinations is based on the patient's response and overall health status.

  4. Step 4

    End of study assessments

    At the end of the study, a comprehensive assessment is conducted to evaluate the overall effectiveness and safety of the vaccine.

    This includes measuring disease control rates, progression-free survival, and overall survival, as well as assessing the quality of life throughout the study.

Who can join the trial?

15 criteria

  • Ability to understand and willingness to sign a written informed consent document.
  • Must be postmenopausal or have evidence of not being able to have children.
  • If there is another cancer, no established additional treatment is available, or the patient is not eligible for it.
  • Willingness to minimize exposure to blood and body fluids after vaccination until the end of the study. This includes not donating sperm, ovary eggs, or blood.
  • Must have a confirmed diagnosis of **fibrolamellar hepatocellular carcinoma (FL-HCC)** or another cancer with the **DNAJB1-PRKACA fusion transcript**. This should be confirmed by specific tests like **RNA-based NGS** or **RT-PCR**. The patient should have achieved complete remission through surgery, radiotherapy, local treatments, or systemic treatments like chemotherapy.
  • Must be at least 12 years old. Note: Patients aged 12 to 17 can only join after 6 adults have already joined the study.
  • Must have an **ECOG performance status** of 2 or less. This is a scale that measures how well a patient can perform daily activities.
  • Must have adequate laboratory values, including:
    • **Absolute Lymphocyte Count** greater than 500 per microliter.
    • **Platelets** greater than 50,000 per microliter.
    • **Creatinine clearance GFR** greater than 30 ml/min.
    • **Alanine aminotransferase (ALT)** and **aminotransferase (AST)** levels no more than 5 times the upper limit of normal.
    • **Bilirubin** levels no more than 3 mg/dl.
    • Must have a negative test for **hepatitis B** or a negative PCR test if the serological test is positive but without active infection. Also, must have a negative test for **hepatitis C** or a negative PCR, and a negative **HIV** test within 6 weeks before joining the study.
    • Female patients who can have children and male patients with partners who can have children must agree to use two effective forms of contraception, with at least one being highly effective. This should start from signing the consent and continue until 3 months after the last vaccination dose.
    • For females who can have children, two negative pregnancy tests are required before the first vaccination. One test should be done during screening and the other within 24 hours before the first vaccination.

Who cannot join the trial?

4 criteria

  • Patients with medical conditions other than **fibrolamellar hepatocellular carcinoma** or tumors with the **oncogenic driver fusion** cannot participate. **Fibrolamellar hepatocellular carcinoma** is a rare type of liver cancer, and **oncogenic driver fusion** refers to a specific genetic change in cancer cells.
  • Patients who are not within the specified age range for the trial cannot participate. The trial is open to certain age groups only.
  • Patients who are not male or female cannot participate, as the trial is open to both genders.
  • Patients who belong to a vulnerable population, which means groups that may need special protection, cannot participate.
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Investigated drugs

Fusion-VAC-XS15 is a peptide vaccine designed to target a specific genetic abnormality found in certain types of cancer, including fibrolamellar hepatocellular carcinoma (FL-HCC). This vaccine works by stimulating the body's immune system to recognize and attack cancer cells that carry the DNAJB1-PRKACA fusion transcript. The goal of using this vaccine in the trial is to assess its ability to provoke an immune response, ensure it is safe for patients, and evaluate its initial effectiveness in treating cancers with this genetic feature.

What is already known about the treatment

Fusion-VAC-XS15 – This medication is administered as a peptide vaccine, designed to be given through injection. It is currently in clinical trials, with research focusing on its safety, immunogenicity, and initial effectiveness. The main therapeutic indication is for patients with fibrolamellar hepatocellular carcinoma and other tumors that have the DNAJB1-PRKACA fusion. The vaccine works by targeting the specific fusion transcript at the molecular level, aiming to stimulate the immune system to recognize and attack cancer cells. It falls under the pharmacological classification of cancer vaccines, which are a type of immunotherapy.

Investigated diseases

  • Fibrolamellar Hepatocellular Carcinoma

    This is a rare type of liver cancer that typically occurs in adolescents and young adults. Unlike other liver cancers, it often develops in individuals without underlying liver disease. The tumor is characterized by large, fibrous bands of tissue within the cancer cells. It can grow slowly and may not cause symptoms until it becomes large. As it progresses, it can lead to abdominal pain, weight loss, and a palpable mass in the abdomen. The disease may spread to nearby organs or distant parts of the body over time.

  • Tumor Entities Carrying the Oncogenic Driver Fusion

    These are tumors that have a specific genetic alteration known as an oncogenic driver fusion. This fusion involves the joining of two genes, which can lead to uncontrolled cell growth and cancer development. Such tumors can occur in various parts of the body and are not limited to a specific organ. The presence of the fusion can influence the behavior and progression of the tumor. These tumors may vary in their growth rate and potential to spread, depending on the specific genes involved in the fusion. Identifying the fusion is crucial for understanding the tumor's characteristics and potential treatment approaches.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519387-41-00Protocol codeFusionVAC22_02Estimated enrolment32 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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