#1 Clinical Trials Search in Europe

Pervi-Fus

A groundbreaking clinical trial is underway to evaluate the effectiveness of a personalized peptide vaccine, including Pervi-Fus, for children and young adults with metastatic fusion-driven sarcomas. This phase I/II trial aims to assess the vaccine’s ability to induce T-cell responses in patients who have undergone standard treatment for Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma. The study focuses on patients in first or second complete remission or partial response, offering hope for improved outcomes in these challenging cancers.

Table of Contents

What is PERVI-FUS?

PERVI-FUS is an innovative personalized peptide vaccine being studied for the treatment of certain types of metastatic sarcomas in children and young adults[1]. It is part of a combination vaccine called IPX vaccine, which also includes two other components: PERVI-NEO and 11902A[1]. This vaccine is designed to be tailored to each patient’s specific cancer characteristics, making it a form of personalized medicine.

Target Conditions

The IPX vaccine, which includes PERVI-FUS, is being studied for patients with specific types of metastatic sarcomas, including:

  • Ewing sarcoma: A rare type of cancer that occurs in bones or in the soft tissue around the bones
  • Alveolar rhabdomyosarcoma: A type of soft tissue cancer that develops in muscle tissue
  • Synovial sarcoma: A rare type of cancer that typically occurs near the joints of the arms or legs

These cancers are referred to as “fusion-driven” sarcomas, which means they are characterized by specific genetic changes that result in the fusion of certain genes[1]. The study focuses on patients who have metastatic disease (cancer that has spread to other parts of the body) and are in first or second complete remission or partial response after standard treatment[1].

How PERVI-FUS Works

PERVI-FUS is part of a personalized vaccine approach. Here’s how it works:

  1. The patient’s tumor is analyzed using advanced genetic sequencing techniques to identify specific gene fusions and mutations[1].
  2. Based on this analysis, a personalized vaccine is created that includes peptides (small protein fragments) that match the patient’s specific cancer characteristics[1].
  3. The vaccine is designed to stimulate the patient’s immune system, particularly T cells, to recognize and attack the cancer cells[1].

The goal is to create a targeted immune response that can help prevent the cancer from returning or progressing[1].

Clinical Trial Details

PERVI-FUS is currently being studied in a Phase I/II clinical trial[1]. Here are some key details about the trial:

  • The main objective is to assess whether the vaccine can induce a T-cell response in patients[1].
  • Secondary objectives include evaluating the safety and tolerability of the vaccine, as well as gathering early data on its effectiveness[1].
  • The trial will measure the vaccine’s ability to stimulate both CD8+ and CD4+ T-cell responses[1].
  • Researchers will also track event-free survival and overall survival at 180 days after treatment[1].
  • The study will assess patients’ quality of life during treatment[1].

Eligibility Criteria

The trial has specific criteria for who can participate. Some key inclusion criteria are:

  • Patients with confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing sarcoma, or synovial sarcoma who have achieved complete remission or partial response after standard therapy[1].
  • Availability of genetic sequencing data for the patient’s tumor[1].
  • Successful design and production of the patient’s individual vaccine[1].

Some exclusion criteria include:

  • Age below 2 or above 40 years (for stage 1 of the trial)[1].
  • Presence of other malignancies within 5 years prior to the study start[1].
  • Certain autoimmune diseases requiring immunosuppressive treatment[1].
  • Pregnancy or unwillingness to use contraception during the study period[1].

Potential Benefits and Risks

While the potential benefits of PERVI-FUS are promising, it’s important to remember that this is an experimental treatment still under investigation. Possible benefits include:

  • A personalized approach to cancer treatment[1].
  • Potential to prevent cancer recurrence or progression[1].
  • Stimulation of the body’s own immune system to fight cancer[1].

However, as with any medical treatment, there may be risks and side effects. The clinical trial is designed to assess these risks and determine the safety of the vaccine[1]. Patients considering participation in the trial should discuss potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Trial Name Personalized peptide vaccine with Pervi-Fus, Pervi-Neo, and 11902A for children and young adults with metastatic fusion-driven sarcomas
Trial Phase Phase I/II
Target Population Patients aged 2-40 years with metastatic Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma in first or second complete remission or partial response
Primary Objective Assess individualized fusion-peptide and neopeptide vaccination-induced T-cell response
Secondary Objectives Evaluate feasibility, safety/tolerability, and gather early efficacy data
Treatment IPX vaccine (including Pervi-Fus) administered as an emulsion for injection
Dosage Maximum daily dose: 0.3 mg; Maximum total dose: 0.9 mg
Primary Endpoint Vaccination-induced T-cell response without unacceptable toxicity
Secondary Endpoints T-cell responses, event-free survival, overall survival, and quality of life

FAQ

  • What is Pervi-Fus and how does it work? Pervi-Fus is a component of a personalized peptide vaccine called IPX vaccine. It works by stimulating the patient's immune system, specifically T-cells, to recognize and target cancer cells based on unique fusion proteins found in certain types of sarcomas.
  • Who is eligible for this clinical trial? The trial is open to patients aged 2-40 years with metastatic fusion-driven sarcomas (Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma) who are in first or second complete remission or partial response after standard treatment.
  • What are the main objectives of the trial? The primary objective is to assess the vaccine-induced T-cell response. Secondary objectives include evaluating the feasibility and safety of the vaccination, as well as gathering early efficacy data on event-free and overall survival.
  • How is the vaccine administered? The IPX vaccine, which includes Pervi-Fus, is administered as an emulsion for injection. The maximum daily dose is 0.3 mg, with a total maximum dose of 0.9 mg over the treatment period.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include a personalized approach to cancer treatment and the possibility of improved outcomes. Risks may include side effects from the vaccine and the uncertainty of its effectiveness. The trial closely monitors patients for any adverse events and assesses quality of life during treatment.

Ongoing Clinical Trials on Pervi-Fus

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

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Fusion-driven sarcomas: A type of cancer that develops in soft tissues or bones, characterized by specific genetic alterations where two genes fuse together, leading to abnormal cell growth.
  • Ewing sarcoma: A rare type of cancer that occurs in bones or in the soft tissue around the bones, primarily affecting children and young adults.
  • Alveolar rhabdomyosarcoma: An aggressive type of soft tissue cancer that develops from skeletal muscle cells and primarily affects children and adolescents.
  • Synovial sarcoma: A rare type of cancer that can occur in various locations of the body, most commonly near large joints in the arms or legs.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Complete remission (CR): A state where all signs and symptoms of cancer have disappeared, though cancer may still be present in the body.
  • Partial response (PR): A decrease in the size or extent of cancer in response to treatment, but not a complete disappearance.
  • T-cell response: The activation of T-cells (a type of white blood cell) by the immune system to recognize and attack specific targets, such as cancer cells.
  • Peptide vaccine: A type of vaccine that uses small pieces of proteins (peptides) to stimulate an immune response against specific targets, such as cancer cells.
  • Event-free survival (EFS): The length of time after treatment during which no specified events (such as disease progression or recurrence) are detected.

References

  1. http://clinicaltrials.eu/trial/study-of-personalized-peptide-vaccine-with-pervi-fus-pervi-neo-and-11902a-for-children-and-young-adults-with-metastatic-fusion-driven-sarcomas/