GlioblastomaPhase 1WinGlio-ipiNCT07134842
A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.
A Phase 1 study testing Ipilimumab (3 mg/kg) in people with Glioblastoma and Gliosarcoma, Adult, run by University College, London at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category
- What is being tested?
- Ipilimumab (3 mg/kg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2025to 1 Jan 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
WinGlio Trial Manager contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, Greater London, NW1 2PG
Hasina Mangal, 020 3447 2929, hasina.mangal1@nhs.net
Paul Mulholland, MBBS, PhD
About this study
Official title: Window Studies in Glioblastoma: A Phase I Trial Investigating Neoadjuvant Ipilimumab in Newly Diagnosed Glioblastoma
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
- Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category
- Being tested
- Ipilimumab (3 mg/kg)
- Keywords
- phase 1, immunotherapy, Brain Cancer, Glioblastoma
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipilimumab (3 mg/kg)Biological
All participants will be treated with ipilimumab (3mg/kg) for up to 2 cycles. Each cycle will last 21 days with participants receiving ipilimumab on the 1st day of the cycle.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All patients will be treated with up to two cycles of ipilimumab prior to their standard treatment. Each cycle will last 21 days. Receives: Biological: Ipilimumab (3 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and tolerability of neoadjuvant ipilimumab as assessed by serious and non-serious adverse events, graded according to CTCAE v5.0
Measured: From trial registration to 3 months post ipilimumab administration
Overall Survival at 12 months post trial registration
Measured: From trial registration to 1 year post treatment
Feasibility of neoadjuvant ipilimumab
The number of patients and percentage of patients completing neoadjuvant ipilimumab regimen will be reported.
Measured: Upon the final patient completing treatment
Best overall objective response rate
Measured: Through study completion, an average of 14 months
Secondary outcomes (10)
Overall survival at 24 months
Measured: From date of registration up to 104 weeks
Progression Free Survival
Measured: From date of registration up to date of progression
Surgical Complications
Measured: During surgery
Treatment Compliance
Duration on treatment will be measured from treatment start to treatment discontinuation; reasons for treatment delays, dose omissions, dose reductions and treatment discontinuation will be collected; Time to surgery will also be measured and reasons for no surgery.
Measured: Through treatment completion, an average of 42 days
Changes in Eastern Cooperative Oncology Group performance status
Measured: From baseline to end of 12 month follow up
Resection Rate
Measured: postprocedural
Patient Acceptability
Patient acceptability will be assessed as the percentage of eligible patients who decline participation in the trial, and the percentage of patients who begin the neoadjuvant ipilimumab treatment but discontinue after one cycle to opt for earlier surgery or chemotherapy.
Measured: Through treatment completion, average of 42 days
Surgeon Acceptability
Surgeon acceptability will be determined by the percentage of eligible patients who are not enrolled in the trial due to a surgeon's decision.
Measured: Baseline
Delay in Surgery
Delay in surgery will be defined as the time from trial registration to the date of surgery, with a focus on identifying any delays that may result from participation in the neoadjuvant treatment arm.
Measured: Date of registration to date of surgery
Changes in Health Related Quality of Life (HRQoL) as measure by EORTC QLQ-C30 and QLQ-BN20
Measured: Screening to 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start10 Jul 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Mulholland, MBBS, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134842
- Sponsor's protocol ID
- UCL/176169
- Acronym
- WinGlio-ipi
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No