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Study of Personalized Peptide Vaccine with PERVI-FUS, PERVI-NEO, and 11902A for Children and Young Adults with Metastatic Fusion-Driven Sarcomas

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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 certain types of cancer known as fusion-driven sarcomas. These are rare cancers that can spread to other parts of the body, a process known as metastasis. The specific types of sarcomas being studied include Ewing sarcoma, alveolar rhabdomyosarcoma, and synovial sarcoma. The trial is designed for patients who have already undergone standard treatments and are in a state of either complete or partial remission, meaning the cancer has either disappeared or reduced in size.

The treatment being tested in this study is an IPX vaccine, which is an emulsion for injection. This vaccine is made up of specific proteins, including PERVI-FUS, PERVI-NEO, and 11902A. The purpose of the study is to see if this vaccine can help the body's immune system, particularly T-cells, to respond to the cancer. T-cells are a type of white blood cell that play a crucial role in the immune response. The study will compare the effects of the vaccine to a placebo, which is a substance with no active ingredients.

Participants in the study will receive the vaccine over a period of time, with the maximum treatment period being 113 days. The study will monitor the participants' immune response to the vaccine, as well as their overall health and quality of life during the treatment. The primary goal is to determine if the vaccine can successfully induce a T-cell response without causing unacceptable side effects. The study will also look at other factors, such as the participants' event-free survival and overall survival at 180 days after the start of the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring that the sarcoma is in complete or partial remission after standard treatment.

    Eligibility is confirmed through specific tests, including whole exome sequencing and RNA sequencing, to ensure the presence of a fusion-driven sarcoma.

  2. Step 2

    Vaccine preparation

    An individualized vaccine cocktail is designed and produced based on the specific characteristics of the sarcoma. This process is essential to tailor the treatment to the patient's unique needs.

  3. Step 3

    Vaccination phase

    The IPX vaccine is administered as an emulsion for injection. The exact dosage and frequency are determined by the study protocol and the patient's specific condition.

    The goal of this phase is to induce a T-cell response, which is a type of immune response, to the patient-specific peptides.

  4. Step 4

    Follow-up visit

    A follow-up visit is scheduled 28 days, with a possible variation of plus or minus 7 days, after the last vaccination. During this visit, the success of the treatment is evaluated by checking for a vaccination-induced T-cell response.

    The follow-up also monitors for any side effects or toxicity related to the vaccine.

  5. Step 5

    Final assessment

    The final assessment occurs at day 180 of the study. This includes measuring T-cell responses and evaluating overall survival and quality of life.

    The study aims to determine the event-free survival and overall survival rates at this point.

Who can join the trial?

8 criteria

  • Patients must have a type of cancer called fusion-driven metastatic sarcoma. This includes Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma.
  • Patients should be in their first or second complete remission (no signs of cancer) or partial response (cancer has shrunk but is still present).
  • Patients must have completed local therapy and intensive standard chemotherapy.
  • Specific genetic information about the cancer must be available. This includes whole exome sequencing and RNA sequencing data, which are tests that look at the genes in the cancer cells.
  • A personalized vaccine for the patient must have been successfully created.
  • Patients must have reached a complete or stable partial remission after finishing additional cancer treatments.
  • Both male and female patients are eligible to participate.
  • Patients must be part of a vulnerable population, which means they may need extra protection or care.

Who cannot join the trial?

5 criteria

  • Patients who do not have a type of cancer called fusion-driven metastatic sarcoma cannot participate. This includes specific types like Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma.
  • Patients who are not in their first or second complete remission or partial response cannot participate. Remission means the cancer is not currently active or is less active.
  • Patients who are not within the specified age range cannot participate. The age range includes children and young adults.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.
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Investigated drugs

Individualized Peptide Vaccine is a special type of treatment designed specifically for each patient. It is made up of small proteins called peptides that are unique to the cancer cells in a patient's body. The goal of this vaccine is to help the immune system recognize and attack the cancer cells more effectively. In this trial, the vaccine is used for patients with a type of cancer called fusion-driven sarcomas, which have spread to other parts of the body. The vaccine is given after the standard treatment to see if it can boost the body's immune response against the cancer.

What is already known about the treatment

Individualized Peptide Vaccine – This medication is administered as a vaccine, which means it is given as an injection to help the body’s immune system fight against certain types of cancer. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main use of this vaccine is to treat patients with specific types of cancer called fusion-driven sarcomas, such as Ewing sarcoma, alveolar rhabdomyosarcoma, and synovial sarcoma, especially when the cancer has spread to other parts of the body. The vaccine works by stimulating the immune system to recognize and attack cancer cells, using specially designed proteins called peptides that are unique to each patient’s cancer. This medication falls under the category of immunotherapy, which is a type of treatment that uses the body’s own defense system to fight diseases.

Investigated diseases

  • Ewing Sarcoma

    Ewing sarcoma is a type of cancer that occurs in bones or in the soft tissue around the bones. It often begins in the long bones of the arms and legs, pelvis, or chest. The disease is characterized by the rapid growth of cancer cells, which can lead to pain and swelling in the affected area. As it progresses, the tumor may spread to other parts of the body, including the lungs and other bones. The exact cause of Ewing sarcoma is not well understood, but it is believed to involve genetic changes. It primarily affects children and young adults.

  • Alveolar Rhabdomyosarcoma

    Alveolar rhabdomyosarcoma is a rare and aggressive form of cancer that arises from skeletal muscle tissue. It is most commonly found in the arms, legs, and trunk, but can also occur in other areas of the body. The disease is characterized by the formation of small, round cancer cells that grow rapidly and can invade surrounding tissues. As it progresses, it may spread to other parts of the body, such as the lungs, lymph nodes, and bone marrow. This type of cancer is more common in adolescents and young adults. The exact cause is not fully understood, but genetic factors are believed to play a role.

  • Synovial Sarcoma

    Synovial sarcoma is a rare type of cancer that typically occurs near the joints of the arm, neck, or leg. It is characterized by the growth of cancerous cells in the soft tissues, which can include muscles, fat, blood vessels, or nerves. The disease often presents as a slow-growing mass, which may cause pain or swelling as it enlarges. Over time, the tumor can invade nearby tissues and spread to other parts of the body, such as the lungs. Synovial sarcoma is most commonly diagnosed in young adults. The exact cause is not well understood, but it is associated with a specific genetic mutation.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511337-35-00Protocol codePerVisionEstimated enrolment23 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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