Clinical trial • Phase I • Oncology

ipilimumab for Glioblastoma|Glioblastoma multiforme

Phase I trial of ipilimumab for Glioblastoma|Glioblastoma multiforme. 18 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Glioblastoma|Glioblastoma multiforme
Trial Stage
Phase I
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
04-12-2023
First CTIS Authorization Date
18-03-2024

Trial design

Phase I trial across 1 site in Belgium.

Target Sample Size
18

Eligibility

Recruits 18 Vulnerable population not selected; trial includes adult patients; no assent or special consent handling described..

Vulnerable Population
Vulnerable population not selected; trial includes adult patients; no assent or special consent handling described.

Recruitment

Planned Sample Size
18
Recruitment Window Months
29

Geography

Total Number Of Sites
1
Total Number Of Participants
18

Belgium

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
03-06-2025
Processing Time Days
463
Number Of Sites
1
Number Of Participants
18

Sites

Site Name
UZ Brussel
Department Name
Medical Oncology
Principal Investigator Name
Bart Neyns
Principal Investigator Email
bart.neyns@uzbrussel.be
Contact Person Name
Bart Neyns
Contact Person Email
bart.neyns@uzbrussel.be
Number Of Participants
18

Sponsor

Primary sponsor

Full Name
UZ Brussel
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Ipilimumab
Active Substance
ipilimumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous; Intracranial
Route
Intravenous; Intracranial
Investigational Product Name
Nivolumab
Active Substance
nivolumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous; Intracranial
Route
Intravenous; Intracranial
Combination Treatment
Yes

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