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Clinical Trials/EUCTR2022-002793-91-DE
EUCTR2022-002793-91-DE
Active, not recruiting
Phase 1

Prospective phase I/II trial of an individualized peptide vaccine in pediatric and AYA patients with metastasized fusion-driven sarcomas following standard treatment - Pervision

niversity Hospital Tuebingen0 sites23 target enrollmentJanuary 31, 2023
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital Tuebingen
Enrollment
23
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital Tuebingen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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