Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)

Sponsor
University Hospital Tuebingen
Study ID
NCT06094101
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Ewing Sarcoma
  • Rhabdomyosarcoma
  • Synovial Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Peptide vaccine IPX — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Oct 23, 2023
Start date
Sep 19, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Peptide vaccination
    Peptides will be administered subcutaneously (s.c.) together with the novel toll like receptor (TLR) 1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant. Three vaccinations will be applied every 28 days.

Primary Outcome Measure

Success of treatment [ Time Frame: Follow-up visit at 28 +/- 7 days after last vaccination ]

Central Contacts

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