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Title
Status

 

U-R-Immune - U-R-Immune Glioma (CA209-1245): A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)

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U-R-Immune - U-R-Immune Glioma (CA209-1245): A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)

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DiagnosisHigh Grade Glioma, Replication Repair DeficientStudy StatusOpen
PhaseN/A
Age12 Months to 25 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDrug: Nivolumab All patients will be administered Nivolumab with or without radiation
Last Posted Update2024-12-12
ClinicalTrials.gov #NCT06519682
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 This study is eligible for STEP-1 funding. Find more information here

 This study is eligible for STEP-1 funding. Find more information here

 

This study is testing a medicine called nivolumab for people with a type of brain cancer called RRD-glioblastoma. The goal is to see if this medicine can help delay or avoid the need for radiation treatment.

 

Inclusion Criteria
  • Patient must be between 1 and 25 years old.
  • Must have glioblastoma, confirmed by a biopsy
  • Tumor must show certain genetic changes linked to RRD, confirmed by tests on the tumour
  • A sample of the tumor is needed for analysis, and another sample may be required if the tumor grows back
  • Most or all of the tumor must have been removed in surgery, and treatment should start within 4 weeks after surgery.
  • No treatments (like chemotherapy or radiation) for glioblastoma are allowed before the study, but surgery is okay. Past treatment for other cancers is allowed if previous cancer is in remission
  • Must have good overall health, including healthy organs and no serious infections
  • Participants and their families must agree to join the study

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.