RecruitingNot ApplicableNCT06519682

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)

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)


Sponsor

Daniel Morgenstern

Enrollment

20 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is open label, multicentre, single arm, pilot study of upfront nivolumab in patients with RRD-glioblastoma with favorable immune/genomic biomarkers. The purpose of the study is to use upfront immune checkpoint inhibitor (ICI) to delay/avoid radiation for patients with RRD-glioblastoma with favorable clinical (Gross total resection (GTR) or near total resection (NTR)) and biological (RRD, hypermutation, immune activation) biomarkers. At progression, patients will be undergoing surgery/biopsy and will get a combination of radiation + ICI followed by maintenance ICI. This model will allow us to additionally study the evolution tumor in response to ICI. The study will have two domains.


Eligibility

Min Age: 12 MonthsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nivolumab and Radiation for people with high grade glioma and replication repair deficient. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Months to 25 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

All patients will be administered Nivolumab with or without radiation

RADIATIONRadiation

Radiation


Locations(1)

Hospital for Sick Children

Toronto, Ontario, Canada

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NCT06519682


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