Actively Recruiting
A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.
Led by University College, London · Updated on 2026-04-09
16
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
WinGlio is a phase I study investigating neoadjuvant (before surgery) ipilimumab ( a type of immunotherapy drug) in patients with newly diagnosed glioblastoma (a form of brain cancer). Participants will receive up to 2 cycles of ipilimumab prior to the standard of care treatments for this patient group which can include debulking surgery and chemoradiation. The aim of giving the ipilimumab to the participants is to see if it is safe to treat patients with this condition with ipilimumab and also to see if the drug helps to reduce or control the patient's disease.
CONDITIONS
Official 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 69 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 50 mL/min
- Adequate liver function with bilirubin 1.5 x upper limit of normal (ULN) or 3 x ULN if Gilbert's Syndrome, and AST or ALT 2.5 x ULN
- Life expectancy greater than 12 weeks
- Willing to comply with contraceptive requirements
- Willing and able to comply with scheduled visits, treatments, laboratory tests, and study procedures
- Written informed consent
You will not qualify if you...
- Known extracranial metastatic or leptomeningeal disease
- Prior treatment for glioblastoma other than biopsy or limited resection leaving residual disease
- Dexamethasone dose greater than 3 mg daily (or equivalent) at study treatment start
- Antibiotics received within 30 days prior to starting treatment, except prophylactic antibiotics with surgery
- Significant intratumoural or peritumoural hemorrhage
- Active autoimmune disease except certain skin conditions and controlled type 1 diabetes or thyroid disease
- Severe or uncontrolled respiratory, cardiac, hepatic, or renal disease
- Known hypersensitivity to ipilimumab or its excipients
- History of interstitial lung disease or related conditions requiring steroids
- Systemic corticosteroids or immunosuppressive treatment within 14 days prior to study treatment
- Treatment with other investigational agents within 28 days or 5 half-lives prior to ipilimumab
- History of previous cancer within 5 years except certain treated cervical and skin lesions
- Positive Hepatitis B or C serology with specific monitoring requirements
- Prior immunodeficiency, organ transplant requiring immunosuppression, or HIV/AIDS
- Conditions or therapies that could interfere with study participation or results
- Pregnant or breastfeeding women
AI-Screening
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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
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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