NCT06097975

A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma

A Phase I Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this phase I interventional study is to determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable reccurent glioblastoma. Participants will: * receive neo-adjuvant administration of intravenous immunotherapy * followed by a maximal safe neurosurgical resection * afterwards, immunotherapy will be injected into the brain tissue * followed by insertion of an Ommaya reservoir * postoperatively, administration of immunotherapy will be continued

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV	Participants will receive neo-adjuvant administration of intravenous immunotherapy on day 1 + day 22: ipilimumab + nivolumab IV.
PROCEDURE	Neurosurgery and intracavitary injection nivolumab and ipililumab	The neo-adjuvant therapy will be followed by a maximal safe surgery resection of the glioblastoma. Immunotherapy (nivolumab + ipililumab) will be injected into the brain tissue, followed by insertion of an Ommaya reservoir
DRUG	Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary	Postoperatively, administration of immunotherapy will be continued, on day 15 postoperatively and every 2 weeks thereafter patients will receive nivolumab IV as well as ipililumab + nivolumab intracavitary.

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-10-24
• Last updated: 2025-01-20

Locations

1 site across 1 country: Belgium