Actively Recruiting
Combined (Neo-)Adjuvant Intravenous and Intracranial Ipilimumab and Nivolumab Treatment in Recurrent Glioblastoma: A Phase I Clinical Trial
Led by Universitair Ziekenhuis Brussel · Updated on 2025-01-20
18
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment approach for patients with recurrent glioblastoma that can be surgically removed. This phase I trial aims to assess the safety and feasibility of combining intravenous and direct brain immunotherapy around the time of surgery. The investigational treatment involves giving immune-boosting drugs before and after tumor removal to evaluate their potential in managing glioblastoma recurrence. Participants will first receive intravenous immunotherapy with the drugs ipilimumab and nivolumab on day 1 and day 22. Then they will undergo a maximal safe brain surgery to remove the tumor, followed by direct injection of the same immunotherapy drugs into the brain tissue and placement of an Ommaya reservoir to allow continued drug delivery. After surgery, participants will continue to receive intravenous nivolumab along with intracavitary injections of ipilimumab and nivolumab every two weeks. During the study, participants will be closely monitored with regular visits, laboratory tests, and imaging scans such as MRI and PET/CT to assess tumor status and treatment safety. Researchers will track immune responses and side effects over one year, with longer follow-up planned to estimate anti-tumor effects. Overall, the trial involves multiple stages of treatment and assessments to carefully evaluate this combined immunotherapy approach for recurrent glioblastoma.
CONDITIONS
Brief 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 prior to any study procedures
- Willingness and ability to comply with study visits, treatments, tests, and biopsies
- Histopathological diagnosis of IDH wild-type WHO grade IV glioblastoma
- Diagnosis of resectable recurrent glioblastoma after standard treatment including surgery, radiation, and chemotherapy
- Presence of a measurable tumor lesion on MRI with specific size criteria
- No evidence of significant intra-tumor bleeding on prior or baseline imaging
- No ventriculo-peritoneal drain
- Eligible for MRI, PET/CT, and CT imaging with contrast
- ECOG performance status of 0, 1, or 2
- At least 4 months since end of radiation therapy and 4 weeks since last temozolomide dose unless progression confirmed
- Adult males or females aged 18 years or older
- Resolution of acute side effects from prior treatments to grade 0 or 1 except alopecia
- Adequate organ function based on blood tests and hormone levels
- No prior treatment with nivolumab, ipilimumab, anti-CTLA-4, or anti-PD-1/-L1 therapies
- No gastrointestinal conditions affecting medication absorption or active bleeding
- No uncontrolled hypertension; controlled hypertension allowed
- No concurrent participation in other therapeutic trials
- No permanent therapeutic anticoagulation required
- No active autoimmune disease except certain controlled conditions
- No recent systemic corticosteroids or immunosuppressants above specified doses
- No active uncontrolled seizure disorders
- No recent serious cardiac or cerebrovascular events
- No known HIV/AIDS-related illness
- No serious uncontrolled medical disorders or active infections
- No other recent malignancies except certain treated cancers with no evidence of disease for 5 years
- No severe psychiatric or medical conditions impairing study participation
- Ability to give informed consent and comply with protocol
- Female patients must use effective contraception or be sterile/postmenopausal and have negative pregnancy tests
You will not qualify if you...
- Inability to provide informed consent
- Unwillingness or inability to comply with study requirements
- Non-IDH wild-type glioblastoma or other brain tumor types
- Non-resectable tumor recurrence or progression
- Tumor lesions not meeting size or imaging criteria
- Evidence of spontaneous intra-tumor hemorrhage
- Presence of ventriculo-peritoneal drain
- Contraindications to imaging with contrast agents
- ECOG performance status greater than 2
- Less than required intervals since radiation or chemotherapy unless progression confirmed
- Prior treatment with immunotherapies targeting CTLA-4 or PD-1/PD-L1
- Active gastrointestinal abnormalities affecting drug absorption or bleeding
- Uncontrolled hypertension
- Participation in other therapeutic clinical trials
- Requirement for permanent therapeutic anticoagulation
- Active autoimmune disease requiring systemic treatment
- Recent use of systemic corticosteroids or immunosuppressants above allowed doses
- Active uncontrolled seizure disorder
- Recent serious cardiovascular or cerebrovascular events
- Known HIV/AIDS illness
- Serious uncontrolled medical disorders or infections
- History of other malignancies within 5 years except specified exceptions
- Severe medical or psychiatric conditions posing excess risk
- Dementia or inability to understand consent
- Female patients not using effective contraception or breastfeeding at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive intravenous immunotherapy with ipilimumab and nivolumab on day 1 and day 22 before surgery.
2 visits (in-person)
Duration - 1 day
Participants undergo maximal safe surgical resection of the glioblastoma followed by injection of immunotherapy into brain tissue and insertion of an Ommaya reservoir.
1 visit (in-person, surgical procedure)
Duration - Until disease progression or discontinuation
Postoperative administration of intravenous nivolumab and intracavitary ipilimumab and nivolumab starting 15 days after surgery and continuing every 2 weeks.
Visits every 2 weeks
Duration - Up to 1 year for safety and feasibility; up to 4 years for anti-tumor response
Participants are monitored for safety and anti-tumor response after completion of treatment.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
Research Team
B
Bart Neyns, MD, PhD
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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