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

Sponsor
Universitair Ziekenhuis Brussel
Study ID
NCT06097975
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Mar 15, 2024
Status verified
Jan 2025
Primary completion
Jun 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm

Primary Outcome Measure

Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma. [ Time Frame: 1 year ]

Central Contacts

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