Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519682
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
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:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is open label multicentre single arm pilot study of upfront nivolumab in patients with RRD-glioblastoma with favorable immunegenomic biomarkers The purpose of the study is to use upfront immune checkpoint inhibitor ICI to delayavoid 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 surgerybiopsy 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
Detailed Description:
Domain 1 - Upfront ICI Initially 12 eligible patients will be enrolled for upfront ICI At 12 weeks assessment if 6 patients have response NO radiation for progressionrecurrence an additional 6 patients will be enrolled for upfront ICI Nivolumab will be administered at a dose of 6 mgkg every 4 weeks cycle All patients will be assessed at 12 weeks 3 cycles from the start of ICI If 6 or more out of 12 RRD-glioblastoma will recurprogress no more patients will be recruited to this domain
Domain 2 - Radiation ICI maintenance ICI All the patients experiencing tumor progression on domain 1 will be eligible for domain 2 and will receive a combination of radiation and nivolumab followed by maintenance nivolumab for a total of 2 years 24 cycles To be eligible for domain 2 post recurrence patients will need surgerybiopsy at recurrence If 6 RRD-glioblastoma will recurprogress at 12 weeks on domain 1 then 8 additional eligible patients may be enrolled directly in domain 2
Patients may receive up to a total of approximately 2 years of treatment up to 24 cycles Follow-up may continue for up to one year following treatment discontinuation
Domain 2 - Radiation ICI maintenance ICI All the patients experiencing tumor progression on domain 1 will be eligible for domain 2 and will receive a combination of radiation and nivolumab followed by maintenance nivolumab for a total of 2 years 24 cycles To be eligible for domain 2 post recurrence patients will need surgerybiopsy at recurrence If 6 RRD-glioblastoma will recurprogress at 12 weeks on domain 1 then 8 additional eligible patients may be enrolled directly in domain 2
Patients may receive up to a total of approximately 2 years of treatment up to 24 cycles Follow-up may continue for up to one year following treatment discontinuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None