Klinik für Kinder- und Jugendmedizin

Cooperative Weichteilsarkom Studiengruppe (CWS) is one of the three world-wide soft tissue sarcoma study groups to optimize treatment of children, adolescents and young adults with rare soft tissue sarcomas and benign soft tissue tumors. CWS countries are Austria, Switzerland, Sweden, Finland, Poland and Germany. CWS collaborates with the European pediatric Soft Tissue Sarcoma Study Group EpSSG and Children`s Oncology Group COG as international partner in the United States.

The CWS study center and the organization of the Soft Tissue Sarcoma Registry (SoTiSaR and the upcoming SoTiSaR 2.0) is located at Klinikum Stuttgart, Olgahospital and the University Children's Hospital Tübingen, Chair is Prof. Dr. Monika Sparber-Sauer, Prof. Dr. Martin Ebinger is Co-Chair of the CWS group.

The clinical reference consultation for patients included in the European Soft Tissue Sarcoma Registry (SoTiSaR and the upcoming SoTiSaR 2.0) takes place for local treatment in the weekly tumor web-based conference. Molecular and translational research as well as new immunological approaches are most important to improve future classification of sarcoma and treatment of sarcoma patients. The centers Heidelberg, Tübingen and Frankfurt are affiliated research partners at highest level.

PerVision is a DKTK-funded prospective, multicenter phase I/II clinical trial evaluating a personalized peptide vaccine in pediatric and adolescent/young adult patients with metastasized fusion-driven sarcomas following standard therapy.

The study investigates an individualized immunotherapy approach based on each patient’s tumor-specific mutations and gene fusions. Using sequencing data, neoantigens are identified and used together with the fusion sequence to design a patient-specific vaccine, aimed at inducing a targeted anti-tumor immune response.

The vaccine consists of:

• a mutation-derived neoantigen peptide, and 
• a fusion breakpoint–derived peptide specific to the sarcoma.

Both are selected based on predicted HLA binding and administered subcutaneously together with an immunological adjuvant, XS15.

Study objectives

• Primary: Evaluate safety and immunogenicity (T-cell response) of the vaccine. 
• Secondary: Assess clinical outcomes such as event-free survival, overall survival, and quality of life.

Patient population

• Children and young adults (2–40 years). 
• Diagnoses include Ewing sarcoma, rhabdomyosarcoma, and synovial sarcoma. 
• Patients can be included after achieving CR or stable PR including status post local therapy of remaining residua (PRplus) at end of standard treatment (including maintenance therapy).
• WGS/WES and RNAseq data of the gene fusion must be available (registration to INFORM, MASTER or HEROES-AYA encouraged).

The trial is conducted as an interventional, open-label, multicenter study and aims to establish proof-of-concept for personalized cancer vaccination in sarcoma patients.

Study Team / Key Contacts:

• Principal Investigator: Prof. Martin Ebinger (martin.ebinger@med.uni-tuebingen.de)
• Study Physician: Dr. Joachim Rupprecht (joachim.rupprecht@med.uni-tuebingen.de)
• Scientific Coordinator: Dr. Sophia Scheuermann (Sophia.scheuermann@med.uni-tuebingen.de)
• Study Nurse: Andrea Erle, CPPS Tübinge (andrea.erle@med.uni-tuebingen.de)

In cooperation with the Peter Lang group and the Christian Seitz group we are evaluating the possibilities of a tailored immunotherapy against advanced soft tissue sarcoma including anti-B7-H3 (CD 276) antibody constructs connected with interleukins or adapter-CAR-T-cell system.

• Deutsche Kinderkrebsstiftung
• Deutsche Krebshilfe
• Deutsche José Carreras Leukämie Stiftung
• Deutscher Akademischer Auslandsdienst
• Deutsches Krebsforschungszentrum Heidelberg
• Else-Kröner-Fresenius Stiftung
• Ludwig Hiermaier Stiftung
• Madeleine Schickedanz Kinderkrebsstiftung
• Reinhold-Beitlich-Stiftung

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