Individualized peptide vaccination trial in pediatric, adolecent and young adult patients with metastasized fusion-driven sarcomas following standard treatment

Phase 1

Conditions: The trial will include patients with so called fusion-driven, metastatic sarcomas of the following types:- Ewing sarcoma, - alveolar rhabdomyosarcoma- or synovial sarcomawho are in first or second complete remission or partial response
MedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2022-002793-91-DE

Lead Sponsor: niversity Hospital Tuebingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 23

Inclusion Criteria

•Confirmed metastatic fusion-driven sarcoma (rhabdomyo-, Ewing- and synovial sarcoma, age = 2 to < 40 years) in complete remission (CR) or partial response (PR) after first therapy phase (e.g. neoadjuvant chemotherapy)
•Access to whole exome sequencing and RNAseq data of the gene fusion (fusion-breakpoint RNA sequence) (by participation in INFORM, MASTER, HEROES-AYA or comparable programs).
•Successful design and production of the patient-individual vaccine cocktail
•Patients have reached first or second complete or stable partial remission including local therapy of the remaining residua (PRplus) at the end of cytotoxic treatment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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