NCT06097975: NEO-GLITIPNI

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

Recruiting now Phase 1 Last updated 20 January 2025

What this trial tests

Phase 1 trial testing Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV in Recurrent Glioblastoma in 18 participants. Currently enrolling.

Timeline

15 March 2024

Primary endpoint
1 June 2025

1 December 2025

Quick facts

Lead sponsor	Universitair Ziekenhuis Brussel
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	15 March 2024
Primary completion	1 June 2025
Estimated completion	1 December 2025
Sites	1 location across Belgium

Drugs / interventions tested

• Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV — full drug profile →
• Neurosurgery and intracavitary injection nivolumab and ipililumab
• Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary — full drug profile →

Conditions studied

• Recurrent Glioblastoma — all drugs for Recurrent Glioblastoma →

Sponsor

Universitair Ziekenhuis Brussel — full company profile →

Who can join

18 and older, any sex, with Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapeutic Strategies for the Treatment of Glioblastoma: Current Challenges and Future Perspectives.
   Salvato I, Marchini A. · · 2024 · cited 32× · PMID 38610954 · DOI 10.3390/cancers16071276
2. Immune checkpoint inhibitors for glioblastoma: emerging science, clinical advances, and future directions.
   Badani A, Ozair A, Khasraw M, Woodworth GF, et al · · 2025 · cited 12× · PMID 39570554 · DOI 10.1007/s11060-024-04881-2
3. Immune Checkpoint Inhibitors in Glioblastoma IDHwt Treatment: A Systematic Review.
   Baskaran AB, Kozel OA, Venkatesh O, Wainwright DA, et al · · 2024 · cited 5× · PMID 39766048 · DOI 10.3390/cancers16244148
4. Emerging insights into the immunosuppressive tumor microenvironment and its implications for glioblastoma immunotherapy.
   Nicolaou N, Andreou MS, Neophytou CM, Papageorgis P. · · 2025 · cited 2× · PMID 41208963 · DOI 10.3389/fimmu.2025.1665742
5. Opportunities to Modulate Tumor Ecosystem Toward Successful Glioblastoma Immunotherapy.
   Takahashi M, Mukhamejanova D, Jasewicz H, Acharya N, et al · · 2025 · cited 1× · PMID 40123277 · DOI 10.1111/cas.70052
6. Current Status and Evolution of Immunotherapy in Glioma Management.
   Liu J, Yang G, Cao Z, Qin H, et al · · 2026 · PMID 42158823 · DOI 10.7150/ijms.132708
7. Glioma tumor microenvironment and immunotherapy: past, present, and future.
   Cvitković J, Tan WL, Jiang T, Zhao Z. · · 2025 · PMID 41272822 · DOI 10.1186/s40364-025-00863-2