RecruitingPhase 1Phase 2NCT06094101

Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)

Prospective Phase I/II Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients with Metastasized Fusion-driven Sarcomas Following Standard Treatment

Sponsor

University Hospital Tuebingen

Enrollment

30 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Ewing Sarcoma Rhabdomyosarcoma Synovial Sarcoma

Summary

The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor. This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities. It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine. Primary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.

Eligibility

Min Age: 2 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

The PerVision study is testing personalized cancer vaccines for young patients with rare soft tissue cancers called fusion-driven sarcomas — including rhabdomyosarcoma, Ewing sarcoma, and synovial sarcoma — that have a specific genetic abnormality called a gene fusion. The vaccine is custom-made for each patient based on their tumor's unique genetic signature. **You may be eligible if...** - You are a child, adolescent, or young adult with a confirmed fusion-driven sarcoma - Your cancer is in first or second complete or partial remission after standard chemotherapy and local treatment - Genomic testing data (whole exome and RNA sequencing) of your tumor is available through established cancer networks - You meet additional criteria assessed during a second screening stage involving vaccine design **You may NOT be eligible if...** - Your cancer is not in remission or partial response - The required genetic sequencing data is not available - You have other serious medical conditions that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPeptide vaccine IPX

Peptide vaccine is a combination of 1. class II peptide spanning the sarcoma-specific fusion-breakpoint (fusion-peptide) 2. class-II neopeptide based on a patient-individual nonsynonymous mutation with a high immunogenicity (mutation-based neopeptide). 3. control peptide derived from Survivin. 4. adjuvant: toll like receptor (TLR) 1/2 ligand XS15.