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

Phase 1

Recruiting

• Conditions: Recurrent Glioblastoma
• Interventions: Drug: Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV; Procedure: Neurosurgery and intracavitary injection nivolumab and ipililumab; Drug: Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary

• Registration Number: NCT06097975
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-24
• Study Start: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Neurosurgery and intracavitary injection nivolumab and ipililumab	-
Experimental arm	Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV	-
Experimental arm	Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary	-

Primary Outcome Measures

Name	Time	Method
Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma.	1 year	Incidence of treatment related adverse events (TRAE). TRAE will be collected on a continuous basis. Type, frequency and severity (graded according to the CTCAEv5) will be reported descriptively.

Secondary Outcome Measures

Name	Time	Method
Estimate anti-tumor responses of the proposed investigational (neo-)adjuvant treatment regimen.	4 years	Objective response rate (ORR, according to iRANO criteria) following 4 weeks of neo-adjuvant therapy.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Belgium