enEnglisch
PerVision
Prospective phase I/II trial of an individualized peptide vaccine in pediatric and AYA patients with metastasized fusion-driven sarcomas following standard treatment
Prospective phase I/II trial of an individualized peptide vaccine in pediatric and AYA patients with metastasized fusion-driven sarcomas following standard treatment
Recruiting
Summary
The purpose of the PerVision clinical trial is to evaluate the safety and effectiveness of a personalized peptide vaccine in treating pediatric and young adult patients with metastatic fusion-driven sarcoma. The vaccine is designed to target specific mutations and gene fusions found in each patient's tumor. All patients will receive the peptide vaccine and the adjuvant.
The PerVision trial will consist of the following consecutive phases: ≈180 days screening phase (variable from 90 up to 365 days) and ≈176 days trial phase (variable from 106 to 280 days). The study intervention does not interfere with activities of daily living. Overall study participation will last 7-22 months. During this time, patients have to attend 7 to 9 study visits at the trial site (hospital). The appointments on which no tumor vaccination is planned will last about 30 minutes. The vaccination with examinations, blood sampling and follow-up observation will take several hours.
Patients will be
vaccinated subcutaneous.
Main inclusion criteria
- Age ≥ 2 to < 40 years
- Inclusion criteria for Screening stage 1:
Confirmed metastatic fusion-driven sarcoma (rhabdomyo-, Ewing- and synovial sarcoma) in complete remission (CR) or partial response (PR) after local therapy and standard chemotherapy protocols - Inclusion criteria for Screening stage 2:
Design and production of the patient-individual vaccine cocktail was successful
Sponsor
University Hospital Tuebingen