drugset / Trial / NCT06097975
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2024-03-15
- Primary completion
- 2025-06-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |