A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
Trial Parameters
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
Eligibility Criteria
1. Subjects must have signed and dated an approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study. 3. Histopathological diagnosis of glioblastoma (= IDHwt, WHO grade IV astrocytoma of the central nervous system (Louis, Perry et al. 2021). 4. Diagnosis of resectable glioblastoma recurrence and/or progression following prior standard of care treatment (surgery for resectable lesions, radiation therapy and temozolomide chemotherapy). Recurrence/progression is defined as significant \[according to the investigators assessment\] growth and/or recurrence of the glioblastoma tumor mass on sequential MRI of the brain; 5. The following disease characteristics should be present