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RECRUITING
NCT06094101
PHASE1/PHASE2

Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)

Sponsor: University Hospital Tuebingen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-09-19

Completion Date

2027-09

Last Updated

2024-12-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Peptide 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.

Locations (4)

Pediatrics III, West German Cancer Centre, University Hospital

Essen, Germany

Universitätsklinikum, Klinik für Kinder- und Jugendmedizin

Frankfurt am Main, Germany

Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum

Freiburg im Breisgau, Germany

University Children's Hostpital

Tübingen, Germany