Actively Recruiting
Window Studies in Glioblastoma: A Phase I Trial Investigating Neoadjuvant Ipilimumab in Newly Diagnosed Glioblastoma
Led by University College, London · Updated on 2026-04-09
16
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating neoadjuvant ipilimumab, a type of immunotherapy drug, in patients newly diagnosed with glioblastoma, a form of brain cancer. This phase I study aims to determine if it is safe to treat these patients with ipilimumab before they receive the standard treatments, which may include surgery and chemoradiation. The study is designed to assess safety, feasibility, and whether the drug can help control the disease. All participants will receive up to two cycles of ipilimumab at a dose of 3 mg/kg, with each cycle lasting 21 days. The ipilimumab treatment is given before the standard care treatments such as debulking surgery and chemoradiation. This neoadjuvant approach will be followed by the usual care for glioblastoma patients. Participants will undergo regular assessments including monitoring for treatment-related side effects up to three months after ipilimumab administration. Researchers will also evaluate overall survival at 12 months, feasibility of the treatment, objective response rates, and other secondary outcomes such as progression-free survival, surgical complications, and quality of life measures. The total study duration includes follow-up of up to 24 months after registration.
CONDITIONS
Brief Title
A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiologically or histologically confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Clinically fit and appropriate to receive neoadjuvant ipilimumab followed by standard treatment
- Adequate organ and bone marrow function including hemoglobin 5 g/dL, neutrophils 1.5 x 10^9/L, platelets 100 x 10^9/L, lymphocyte count 1.0 x 10^9/L
- Adequate renal function with creatinine clearance 6 50 mL/min
- Adequate liver function with bilirubin 4 1.5 x ULN (up to 3 x ULN if Gilbert's Syndrome), AST or ALT 2.5 x ULN
- Life expectancy greater than 12 weeks
- Willing to comply with contraceptive requirements
- Willing and able to attend scheduled visits, treatment, lab tests, and procedures
- Written informed consent
You will not qualify if you...
- Presence of extracranial metastatic or leptomeningeal disease
- Prior glioblastoma treatment other than biopsy or limited resection with residual disease
- Use of dexamethasone >3 mg daily or equivalent at treatment start
- Antibiotic use within 30 days prior to study treatment except prophylactic with surgery
- Significant intratumoural or peritumoural hemorrhage
- Active autoimmune diseases except controlled skin conditions, type 1 diabetes, or thyroid disease
- Severe or uncontrolled respiratory, cardiac, hepatic, or renal disease
- Known hypersensitivity to ipilimumab or its excipients
- History or evidence of interstitial lung disease or related conditions requiring steroid treatment
- Systemic corticosteroid or immunosuppressive treatment within 14 days prior to study
- Treatment with other investigational agents within 28 days or 5 half-lives prior to study
- History of cancer within 5 years except treated cervical carcinoma in situ or non-melanoma skin cancer
- Positive Hepatitis B surface antigen or Hepatitis C antibody
- Prior immunodeficiency, organ transplant needing immunosuppression, or known HIV/AIDS
- Any condition or abnormality that may interfere with study participation or results
- Women who are pregnant or breastfeeding
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 - Up to 6 weeks
Participants receive up to two cycles of ipilimumab (3 mg/kg) prior to their standard treatment. Each cycle lasts 21 days with ipilimumab administered on the first day of each cycle.
2 visits (in-person) for ipilimumab administration
Duration - Up to 12 months post treatment
Participants are monitored for safety, survival, and treatment response after completing ipilimumab treatment.
Regular visits for safety and survival assessments during follow-up
Trial Site Locations
Total: 1 location
1
University College London Hospital
London, Greater London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
W
WinGlio Trial Manager
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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