Actively Recruiting
Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)
Led by University Hospital Tuebingen · Updated on 2026-05-04
30
Participants Needed
4
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
D
Deutsches Konsortium fürTranslationale Krebsforschung (DKTK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing sarcoma, or synovial sarcoma in first or second complete remission or partial response after local therapy and intensive chemotherapy
- Availability of whole exome sequencing and RNA sequencing data for fusion gene
- Successful design and production of patient-specific vaccine cocktail
- Complete or stable partial remission at end of adjuvant or maintenance cytotoxic treatment
- Partial remission plus defined as all remaining tumor residua treated locally by surgery or irradiation
- Age 2 to less than 40 years
- Ability to comply with study procedures and follow-up
You will not qualify if you...
- Ejection fraction below 25%
- Creatinine clearance less than 40 ml/min
- Bilirubin above 4 mg/dl
- ALT or AST above 400 units/l
- Severe infections including HIV, hepatitis B or C as defined by positive tests
- Known allergy to study drug components
- Live attenuated vaccine within 28 days before study drug administration
- Previous hematopoietic stem cell or organ transplantation
- Other malignancies within 5 years except low-risk treated curatively
- Use of immunosuppressive agents or cytotoxic medication affecting T cells within specified periods
- Significant psychiatric disabilities affecting participation
- Uncontrolled seizures or severe neuropathy
- Autoimmune diseases requiring immunosuppressive treatment
- Pregnancy or unwillingness to use contraception as required
- Karnofsky or Lansky performance status below 70%
- Participation in another phase I or II trial with investigational drug within 28 days prior to enrollment except specified exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Pediatrics III, West German Cancer Centre, University Hospital
Essen, Germany, 45147
Not Yet Recruiting
2
Universitätsklinikum, Klinik für Kinder- und Jugendmedizin
Frankfurt am Main, Germany, 60590
Not Yet Recruiting
3
Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
4
University Children's Hostpital
Tübingen, Germany, 72076
Actively Recruiting
Research Team
M
Martin Ebinger, Prof. Dr.
CONTACT
J
Joachim Rupprecht, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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