Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive neo-adjuvant administration of intravenous immunotherapy on day 1 + day 22: ipilimumab + nivolumab IV.

Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV

The neo-adjuvant therapy will be followed by a maximal safe surgery resection of the glioblastoma. Immunotherapy (nivolumab + ipililumab) will be injected into the brain tissue, followed by insertion of an Ommaya reservoir

Neurosurgery and intracavitary injection nivolumab and ipililumab

Postoperatively, administration of immunotherapy will be continued, on day 15 postoperatively and every 2 weeks thereafter patients will receive nivolumab IV as well as ipililumab + nivolumab intracavitary.

Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary

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

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

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

PFS and OS estimated by Kaplan-Meier survival analysis (incl. median, 6-months-, and yearly survival rates with 95% CI).

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.

Objective response rate (ORR, according to iRANO criteria) following 4 weeks of neo-adjuvant therapy.

Universitair Ziekenhuis Brussel

prof. dr.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma	NCT06097975	Recurrent Gliob...	Neo-adjuvant ni... Neurosurgery an... Adjuvant nivolu...	18 Years -	Universitair Ziekenhuis Brussel
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma	NCT06097975	Recurrent Gliob...	Neo-adjuvant ni... Neurosurgery an... Adjuvant nivolu...	18 Years -	Universitair Ziekenhuis Brussel

Spots Global Cancer Trial Database for neurosurgery and intracavitary injection nivolumab and ipililumab