drugset / Trial / NCT06097975

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

NCT06097975 ↗

Phase 1 Recruiting 18 enrolled University Hospital Brussels
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

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody — Intravenous
Subject Nivolumab Monoclonal antibody — Intravenous

Indications