Actively Recruiting
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
Led by Universitair Ziekenhuis Brussel · Updated on 2025-01-20
18
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Willing and able to comply with study visits, treatment, lab tests, and biopsies
- Histopathological diagnosis of glioblastoma (IDHwt, WHO grade IV astrocytoma)
- Diagnosis of resectable recurrent glioblastoma after prior standard treatments
- Measurable tumor lesion on brain MRI with gadolinium enhancement (>10 mm longest diameter and >5 mm perpendicular diameter)
- No clinically relevant spontaneous intra-tumor hemorrhage on baseline MRI or history
- No ventriculo-peritoneal drain
- No contraindication for gadolinium enhanced MRI, 18FFET-PET/CT, or whole-body contrast CT
- ECOG performance status of 0, 1, or 2
- At least 4 months since end of postoperative radiation therapy unless progression confirmed after 4 weeks
- At least 4 weeks since last temozolomide administration
- Male or female, age 18 years or older
- Resolution of acute adverse effects from prior treatments to grade 0 or 1 except alopecia
- Adequate organ function including bilirubin, liver enzymes, creatinine, blood counts, and thyroid hormone within defined limits
- No prior treatment on nivolumab and/or ipilimumab trials
- No prior anti-CTLA-4 or anti-PD-1/-L1 targeted therapy
- No gastrointestinal abnormalities affecting medication absorption or active bleeding
- No uncontrolled hypertension; controlled hypertension allowed
- Not currently in another therapeutic clinical trial
- No requirement for permanent therapeutic anticoagulation
- No active uncontrolled seizure disorder
- No recent severe cardiac or cerebrovascular events within 12 months
- No known HIV or AIDS-related illness
- No serious uncontrolled medical disorder or active infection impairing treatment
- No history of other malignancies except certain treated skin or in situ cancers with no evidence for 5 years
- No severe acute or chronic medical or psychiatric condition increasing risk or interfering with study
- No dementia or altered mental status affecting consent or compliance
- Female patients must be surgically sterile, postmenopausal, or use effective contraception and have negative pregnancy tests
- Women must not be breastfeeding at screening
You will not qualify if you...
- Prior treatment with nivolumab or ipilimumab trials
- Prior treatment with anti-CTLA-4 or anti-PD-1/-L1 therapies
- Gastrointestinal problems preventing oral medication or causing active bleeding
- Uncontrolled hypertension
- Concurrent participation in another therapeutic clinical trial
- Requirement for permanent therapeutic anticoagulation
- Active, known, or suspected autoimmune diseases requiring systemic treatment
- Systemic corticosteroids or immunosuppressants within 14 days before enrollment
- Active uncontrolled seizure disorder
- Recent myocardial infarction, unstable angina, bypass surgery, congestive heart failure, unstable arrhythmia, stroke, or TIA within 12 months
- Known HIV or AIDS-related illness
- Serious uncontrolled medical disorder or active infection impairing treatment
- History of malignancies other than glioma except certain treated cancers
- Severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study
- Dementia or altered mental status preventing informed consent or compliance
- Female patients who are pregnant, breastfeeding, or not using effective contraception
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
Research Team
B
Bart Neyns, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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