Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-01 @ 2:03 PM
Study NCT ID:
NCT05074992
Status:
TERMINATED
Last Update Posted:
2024-05-02
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
Sponsor:
University College, London
Organization:
Study Overview
Official Title:
A Phase II Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Support withdrawn from drug company supplying IMP
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeAT Glio
Brief Summary:
The NeAT Glio trial will evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma.
Detailed Description:
This is a phase II trial to evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma.
The trial will recruit 43 patients over 1 year.
Trial Subjects (patients) with newly diagnosed de-novo glioblastoma who are deemed eligible for the trial will be recruited to the study to receive neoadjuvant ipilimumab. Patients will receive 2 cycles of ipilimumab, administered intravenously at a dose of 3mg/kg on day 1 of each 21 day cycle.
Prior to trial entry the patient's treating multidisciplinary team (MDT) consisting of oncologists, radiologists and surgeons must agree that the patient is a suitable candidate for ipilimumab prior to surgery and that surgery may be delayed beyond usual standard of care timelines.
Patients will be assessed on a weekly basis, and disease assessments (including MRI scans) will be performed after each cycle of ipilimumab. Patient responses and associated MRI scans will be reviewed by the MDT to determine that it is safe for the patient to continue with trial treatment. On completion of trial treatment patients will have a further disease assessment (including MRI scan) which will be reviewed with the MDT before continuing to standard of care treatment of debulking surgery and chemoradiation.
Patients demonstrating clinical or radiological deterioration (as determined by the MDT or the principal investigator) at any point, either before starting or whilst receiving ipilimumab, will stop trial treatment and proceed to debulking surgery and chemoradiotherapy as per local policies.
Patients will be followed up every 3 months for 2 years and then annually thereafter.
End of trial will be declared when the final data item for the final patient is received i.e. when the final patient completes their 2 year follow up visit.
The trial will recruit 43 patients over 1 year.
Trial Subjects (patients) with newly diagnosed de-novo glioblastoma who are deemed eligible for the trial will be recruited to the study to receive neoadjuvant ipilimumab. Patients will receive 2 cycles of ipilimumab, administered intravenously at a dose of 3mg/kg on day 1 of each 21 day cycle.
Prior to trial entry the patient's treating multidisciplinary team (MDT) consisting of oncologists, radiologists and surgeons must agree that the patient is a suitable candidate for ipilimumab prior to surgery and that surgery may be delayed beyond usual standard of care timelines.
Patients will be assessed on a weekly basis, and disease assessments (including MRI scans) will be performed after each cycle of ipilimumab. Patient responses and associated MRI scans will be reviewed by the MDT to determine that it is safe for the patient to continue with trial treatment. On completion of trial treatment patients will have a further disease assessment (including MRI scan) which will be reviewed with the MDT before continuing to standard of care treatment of debulking surgery and chemoradiation.
Patients demonstrating clinical or radiological deterioration (as determined by the MDT or the principal investigator) at any point, either before starting or whilst receiving ipilimumab, will stop trial treatment and proceed to debulking surgery and chemoradiotherapy as per local policies.
Patients will be followed up every 3 months for 2 years and then annually thereafter.
End of trial will be declared when the final data item for the final patient is received i.e. when the final patient completes their 2 year follow up visit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: