Individualized peptide vaccination trial in pediatric, adolecent and young adult 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 - Pervision

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002793-91-DE

Enrollment

Registered

2023-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The trial will include patients with so called "fusion-driven", metastatic sarcomas of the following types: - Ewing sarcoma, - alveolar rhabdomyosarcoma - or synovial sarcoma who are in first or second complete remission or partial response MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10065867 Term: Alveolar

Interventions

Product Name: IPX-Vaccine Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Confirmed metastatic fusion-driven sarcoma (rhabdomyo-, Ewing- and synovial sarcoma, age = 2 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Non-CR or progressive PR at the end of adjuvant and/or maintenance cytotoxic treatment (during screening phase) • Age < 2 or = 40 years

Design outcomes

Primary

Measure	Time frame
Main Objective: •To assess individualized fusion-petide and neopetide vaccination induced T-cell response ;Secondary Objective: •To evaluate the feasibility of individualized fusion-petide and neopetide vaccination in a population of patients at very high risk of recurrance and mortality •To assess the safety/tolerability the indivdualized IPX-Vaccine •To gather very early efficacy data by monitoring event free and overall survival as major clinically relevant endpoints for potential planning of future confirmatory / pivotal trials;Primary end point(s): Primary endpoint is "success of treatment", defined as the patient showing a vaccination-induced T cell response to either of the two patient specific peptides without unacceptable toxicity until Follow-up visit (28 ± 7 days after last vaccination).;Timepoint(s) of evaluation of this end point: assessed at 28 ± 7 days after last vaccination	—

Measure

Time frame

Main Objective: •To assess individualized fusion-petide and neopetide vaccination induced T-cell response ;Secondary Objective: •To evaluate the feasibility of individualized fusion-petide and neopetide vaccination in a population of patients at very high risk of recurrance and mortality •To assess the safety/tolerability the indivdualized IPX-Vaccine •To gather very early efficacy data by monitoring event free and overall survival as major clinically relevant endpoints for potential planning of future confirmatory / pivotal trials;Primary end point(s): Primary endpoint is "success of treatment", defined as the patient showing a vaccination-induced T cell response to either of the two patient specific peptides without unacceptable toxicity until Follow-up visit (28 ± 7 days after last vaccination).;Timepoint(s) of evaluation of this end point: assessed at 28 ± 7 days after last vaccination

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Secondary

Measure	Time frame
Secondary end point(s): a. CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides (fusion-peptide and mutation-based neopeptide). b. CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides after completion of the study at day 180. c. Event-free (EFS) at day 180. d. Overall survival (OS) at day 180. e. Quality of life during study treatment. ;Timepoint(s) of evaluation of this end point: day 180 after first vaccination	—

Measure

Time frame

Secondary end point(s): a. CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides (fusion-peptide and mutation-based neopeptide). b. CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides after completion of the study at day 180. c. Event-free (EFS) at day 180. d. Overall survival (OS) at day 180. e. Quality of life during study treatment. ;Timepoint(s) of evaluation of this end point: day 180 after first vaccination

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Countries

Germany

Contacts

Public ContactCPCS

Center for Pediatric Clinical Studies

pervision@med.uni-tuebingen.de00497071294857

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026