A Phase I Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
Overview
- Phase
- Phase 1
- Intervention
- Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV
- Conditions
- Recurrent Glioblastoma
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma.
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Bart Neyns
prof. dr.
Universitair Ziekenhuis Brussel
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental arm
Intervention: Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV
Experimental arm
Intervention: Neurosurgery and intracavitary injection nivolumab and ipililumab
Experimental arm
Intervention: Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary
Outcomes
Primary Outcomes
Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma.
Time Frame: 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 Outcomes
- Estimate anti-tumor responses of the proposed investigational (neo-)adjuvant treatment regimen.(4 years)