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

NCT06097975 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-01-20

No results posted yet for this study

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

Conditions

Interventions

DRUG

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

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

PROCEDURE

Neurosurgery and intracavitary injection nivolumab and ipililumab

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

DRUG

Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary

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.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-06-01
Completion
2025-12-01

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097975 on ClinicalTrials.gov