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DNAJB1-PRKACA trifluoracetate peptide vaccine and atezolizumab in patients with fibrolamellar hepatocellular carcinoma and other DNAJB1-PRKACA fusion tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on patients with fibrolamellar hepatocellular carcinoma and other cancers that contain the genetic change called DNAJB1-PRKACA. Participants receive a specially designed peptide vaccine, which is a tiny piece of protein meant to teach the body’s immune system to recognize and attack the cancer. The vaccine is given together with a medicine known as atezolizumab, which works by immune checkpoint inhibition – a method that helps immune cells stay active against tumor cells.

The purpose of the study is to determine whether the combination can safely trigger an immune response against the cancer. After an initial screening visit, participants receive a series of sub‑cutaneous (under the skin) vaccine injections and periodic intravenous (through a vein) infusions of the medication over several months. Throughout the study, regular clinic visits include simple blood tests and physical examinations to check for side effects and to see how the body’s immune cells respond. The overall schedule is designed to be straightforward, with each visit lasting only a short time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Study Visit

    You attend the first study visit after agreeing to join the trial. During this visit, baseline medical information is recorded and necessary tests are performed to confirm eligibility.

    The medical team explains the purpose of the trial, which is to evaluate a peptide vaccine combined with an immune checkpoint inhibitor for fibrolamellar hepatocellular carcinoma and other tumors that carry the DNAJB1‑PRKACA fusion.

  2. Step 2

    First Intravenous Infusion of Atezolizumab

    You receive an intravenous infusion of the drug atezolizumab (commercially known as Tecentriq). The product is supplied as a concentrate for solution for infusion.

    The specific amount of the drug (e.g., 840 mg or 1,200 mg) is prepared by the study staff according to the protocol, but the exact dose is not disclosed in the public information.

  3. Step 3

    First Subcutaneous Injection of Fusion‑VAC‑XS15

    Immediately after the infusion, you receive a subcutaneous injection of the peptide vaccine called Fusion‑VAC‑XS15. The vaccine contains the DNAJB1‑PRKACA trifluoracetate peptide designed to stimulate your immune system.

    The injection is given in the skin using the provided emulsion for injection; the exact dose is not specified in the available data.

  4. Step 4

    Repeat Treatment Cycles

    You continue to receive additional cycles of treatment throughout the study. Each cycle typically includes another intravenous infusion of atezolizumab and another subcutaneous injection of Fusion‑VAC‑XS15.

    The exact frequency (for example, every two weeks or every month) and total number of cycles are defined by the study protocol, but these details are not listed in the public description.

  5. Step 5

    Safety and Response Monitoring

    During each visit, the study team checks you for any side effects and assesses how your body is responding to the vaccine and the immune checkpoint inhibitor.

    Blood tests, imaging studies, and questionnaires about quality of life may be performed to monitor safety, tumor response, and overall health.

  6. Step 6

    End of Treatment and Follow‑Up

    After the planned number of treatment cycles is completed, you stop receiving the study drugs.

    You continue to be followed for a period of time to evaluate long‑term outcomes such as disease progression, overall survival, and quality of life.

Who can join the trial?

23 criteria

  • Be able to understand the study information and sign a written consent form.
  • Be at least 14 years old.
  • Have disease that can be measured by doctors using iRECIST (a system that tracks tumor size on scans).
  • Show adequate organ function, which means:
    • White blood cell count (absolute lymphocyte count) greater than 500 per microliter.
    • Platelet count greater than 50,000 per microliter.
    • Kidney function (creatinine clearance) with a glomerular filtration rate (GFR) above 30 ml/min.
    • Liver function classified as Child‑Pugh class A or B7 (a score that evaluates how well the liver works).
    • Liver enzymes ALT and AST no higher than five times the normal upper limit.
    • Blood bilirubin level no higher than 3 mg/dL (bilirubin measures how well the liver processes waste).
    • If you are younger than 18, you must weigh at least 40 kg.
    • If you do not have fibrolamellar liver cancer, you can join if your disease has gotten worse after standard treatment and:
      • There is no further standard therapy available, or
      • The standard therapy is not suitable for you, or
      • You choose not to receive the standard therapy, or
      • There is no standard therapy at all for your condition.
      • Have negative test results for:
        • Hepatitis B (or a negative PCR test if a blood test was positive but there is no active infection),
        • Hepatitis C RNA, and
        • HIV, tested within the 6 weeks before joining the study.
        • Women who could become pregnant and men with partners who could become pregnant must agree to use two effective forms of birth control (at least one highly effective method) starting when you sign the consent and continuing until five months after the last study drug dose.
        • Women who could become pregnant must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) before the first vaccine dose—one at the screening visit and another taken less than 24 hours before the first vaccination.
        • Be postmenopausal or have other evidence showing you cannot become pregnant.
        • Have a confirmed diagnosis of fibrolamellar hepatocellular carcinoma or another advanced, inoperable or metastatic cancer.
        • Show the presence of the DNAJB1‑PRKACA fusion transcript (a specific genetic change) as detected by either RNA‑based NGS or RT‑PCR laboratory tests.
        • Have an ECOG performance status of 0 or 1 (meaning you are fully active or able to carry out light work).

Who cannot join the trial?

18 criteria

  • Pregnant or breastfeeding – you cannot be pregnant or feeding a baby at the time of the study.
  • Unable or unwilling to follow the study schedule – you must be able to attend all required visits and follow the plan.
  • Received chemotherapy, other systemic (body‑wide) treatment, or radiotherapy (radiation treatment) within the last 14 days before the first dose.
  • Participated in another clinical trial with an experimental cancer drug or any other experimental treatment within the past 30 days.
  • Had major surgery (large operation) within 28 days before receiving the study drug.
  • Still experiencing side effects from previous cancer treatment that have not fully resolved, except for hair loss or mild nerve problems.
  • Received immunotherapy drugs (such as anti‑PD‑1, anti‑PD‑L1, anti‑PD‑L2, or anti‑CTLA‑4 antibodies) within 28 days before the study drug.
  • Received any live vaccine (a vaccine that contains a weakened form of a virus or bacteria) within 28 days before treatment.
  • Known allergy or past allergic reaction to any of the study drugs or to products made in Chinese hamster ovary cells.
  • History of severe autoimmune reactions caused by immunotherapy (grade 3 or higher) – these are strong immune attacks on the body’s own tissues.
  • History of a severe allergic (anaphylactic) reaction to antibody medicines or fusion proteins.
  • Has an active autoimmune disease that needed strong immune‑suppressing medicines in the past two years.
  • Has any organ or tissue transplant (including cornea) or a history of stem cell transplant from another person.
  • Has a diagnosed immunodeficiency – a condition that makes the immune system weak.
  • Has taken systemic corticosteroids (more than 10 mg of prednisone‑equivalent per day) or other immune‑suppressing drugs within 7 days before the study drug.
  • Has symptomatic interstitial lung disease – ongoing inflammation of the lung tissue that causes symptoms.
  • Has active or untreated brain metastases (cancer spread to the brain) or leptomeningeal metastases (cancer spread to the lining of the brain and spinal cord).
  • Has uncontrolled other illnesses, such as uncontrolled infection, heart failure, unstable chest pain, irregular heartbeat, another cancer, or mental health/social problems that would make it hard to follow the study requirements.
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Investigated drugs

  • Tecentriq

    is a medication that blocks a protein called PD‑L1. By blocking this protein, it helps the body’s immune system see and attack cancer cells. In this study, the drug is given through an IV infusion and is combined with a vaccine to see if it improves the body’s ability to fight the cancer and to check that the combination is safe.

  • Fusion-VAC-XS15

    is a peptide‑based vaccine that teaches the immune system to recognize a specific abnormal protein (the DNAJB1‑PRKACA fusion) that can drive certain cancers. It is given as a small injection under the skin. The goal of the vaccine in the trial is to trigger the body’s T‑cells to target and destroy tumor cells that carry this abnormal protein.

What is already known about the treatment

  • Atezolizumab

    This medication is given as an intravenous infusion using a sterile solution. It is an approved cancer drug that is already used for several tumor types such as bladder and lung cancer. Atezolizumab works by binding to the PD‑L1 protein on cancer cells, which blocks the signal that stops immune cells from attacking the tumor. It belongs to the class of monoclonal antibodies known as immune‑checkpoint inhibitors.

  • Fusion‑VAC‑XS15

    This product is administered by a subcutaneous injection as an emulsion for injection. It is an experimental peptide vaccine that is still being studied and has not yet received marketing approval. The vaccine contains short pieces of the DNAJB1‑PRKACA fusion protein, which train the body’s T‑cells to recognize and attack tumors that carry this specific genetic change. It is classified as a peptide‑based cancer vaccine, a form of immunotherapy.

Investigated diseases

  • Fibrolamellar hepatocellular carcinoma

    A rare type of liver cancer that typically appears in adolescents and young adults without underlying liver disease. It forms a solid tumor with a characteristic fibrous pattern and can enlarge within the liver over time. The tumor may spread to nearby blood vessels and lymph nodes as it grows. Patients often notice abdominal discomfort or a feeling of fullness as the mass expands.

  • DNAJB1‑PRKACA fusion‑positive tumors

    Tumors that carry the DNAJB1‑PRKACA gene fusion, a specific genetic alteration that drives abnormal cell growth. This fusion can be found in fibrolamellar liver cancer and occasionally in other rare tumor types. The presence of the fusion promotes continuous signaling that encourages the tumor to enlarge. As the tumor enlarges, it can invade surrounding tissue and may metastasize to distant sites.

Trial detailsLast updated 10 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502869-17-01Protocol codeFusionVAC22_01Estimated enrolment20 patientsSponsorUniversitaetsklinikum Tuebingen

sourced from the EU Clinical Trials Register and site verification

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