A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.

Recruiting now · Phase 1

Conditions studied: Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category

In brief

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.

Key facts

Study ID

NCT07134842

Run by

University College, London

People needed

16

Starts

2025-07-10

Expected to finish

2028-01-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiologically or histologically confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma)
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see appendix 3)
• Clinically fit for, and appropriate to receive, neoadjuvant ipilimumab followed by standard of care treatment, based on investigator and MDT judgement
• Adequate organ and bone marrow function:
• Hb ≥9 g/dL
• Neutrophils ≥1.5 x 109/L
• Platelets ≥100 x 109/L
• Lymphocyte count ≥1.0 x 109/L
• Adequate renal function:
• Creatinine clearance of ≥ 50mL/min calculated by Cockroft-Gault equation
• Adequate liver function:
• Bilirubin ≤ 1.5 x ULN (except for patients with known Gilbert's Syndrome who may have total bilirubin ≤ 3 x ULN)
• Aspartate or alanine transferase (AST or ALT) ≤ 2.5 x ULN
• Life expectancy of greater than 12 weeks
• Willing to comply with the contraceptive requirements of the trial (see section 6.3.5)
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
• Written informed consent

You may not qualify if…

• Known extracranial metastatic or leptomeningeal disease
• Prior treatment for glioblastoma other than a biopsy or limited resection leaving residual disease
• Dexamethasone dose >3mg daily (or equivalent) at the time of starting study treatment
• Antibiotics received within 30 days prior to starting study treatment, except for prophylactic antibiotics given with surgery
• Intratumoural or peritumoural haemorrhage deemed significant by the treating clinician
• Active autoimmune disease apart from:
• Skin conditions such as psoriasis, vitiligo or alopecia not requiring systemic treatment
• Type 1 diabetes or thyroid disease, controlled on medication
• Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
• Known hypersensitivity to ipilimumab or any of its excipients
• Past medical history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced interstitial disease which required steroid treatment or any evidence of clinically active interstitial lung disease.
• Any condition requiring systemic treatment with corticosteroids (>10mg prednisolone daily or equivalent) or other immunosuppressive medications within 14 days prior to starting study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10mg daily prednisolone or equivalent are permitted in the absence of active autoimmune disease.
• Treatment with any other investigational agent within 28 days or 5 half lives of the investigational agent (whichever is longer) prior to starting ipilimumab treatment.
• History of previous cancer within 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions
• Positive serology for Hepatitis B defined as a positive test for HepB surface antigen (HBsAg). Note: patients who are HepB core antibody (HBcAb) positive will only be eligible for the study if the HepB virus deocyribonucleic acid (DNA) test is negative and patients are willing to undergo monthly monitoring for HBV reactivation.
• Positive serology for Hepatitis C defined as a positive test for HCV antibody
• Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy or known HIV or acquired immunodeficiency syndrome (AIDS)-related illness
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• Women who are pregnant or breast feeding

Where it is running

• University College London Hospital — London, Greater London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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