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RecruitingNCT07134842WinGlio-ipiUpdated Apr 9, 2026

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 interventional study of Ipilimumab (3 mg/kg) in Glioblastoma, Gliosarcoma, Adult and Glioblastoma - Category, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by University College, London · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Glioblastoma
  • Gliosarcoma, Adult
  • Glioblastoma - Category

Keywords

  • phase 1
  • immunotherapy
  • Brain Cancer
  • Glioblastoma
03

In context

Glioblastoma

2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.

This study's planned enrollment of 16 is below the median of 36 across 1,753 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Radiologically or confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma)
  2. Age ≥18 years
  3. (ECOG) performance status of 0-1 (see appendix 3)
  4. Clinically fit for, and appropriate to receive, ipilimumab followed by standard of care treatment, based on investigator and MDT judgement
  5. Adequate organ and bone marrow function:

    • ≥9 g/dL
    • Neutrophils ≥1.5 x 109/L
    • ≥100 x 109/L
    • Lymphocyte count ≥1.0 x 109/L
  6. Adequate renal function:

    • of ≥ 50mL/min calculated by Cockroft-Gault equation
  7. Adequate liver function:

    • ≤ 1.5 x (except for patients with known Gilbert's Syndrome who may have total bilirubin ≤ 3 x ULN)
    • Aspartate or alanine transferase ( or ALT) ≤ 2.5 x ULN
  8. of greater than 12 weeks
  9. Willing to comply with the requirements of the trial (see section 6.3.5)
  10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
  11. Written

Exclusion criteria

Exclusion Criteria:

  1. Known extracranial or
  2. Prior treatment for glioblastoma other than a or limited resection leaving residual disease
  3. Dexamethasone dose >3mg daily (or equivalent) at the time of starting study treatment
  4. Antibiotics received within 30 days prior to starting study treatment, except for prophylactic antibiotics given with surgery
  5. Intratumoural or peritumoural haemorrhage deemed significant by the treating clinician
  6. Active disease apart from:

    1. Skin conditions such as psoriasis, vitiligo or alopecia not requiring systemic treatment
    2. Type 1 diabetes or thyroid disease, controlled on medication
  7. Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  8. Known to ipilimumab or any of its
  9. Past medical history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced interstitial disease which required treatment or any evidence of clinically active interstitial lung disease.
  10. Any condition requiring systemic treatment with corticosteroids (>10mg prednisolone daily or equivalent) or other 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.
  11. Treatment with any other agent within 28 days or 5 half lives of the investigational agent (whichever is longer) prior to starting ipilimumab treatment.
  12. 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
  13. Positive serology for 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.
  14. Positive serology for defined as a positive test for HCV antibody
  15. Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy or known or acquired immunodeficiency syndrome (AIDS)-related illness
  16. 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
  17. Women who are pregnant or breast feeding
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Interventional

    All patients will be treated with up to two cycles of ipilimumab prior to their standard treatment. Each cycle will last 21 days.

    Biological: Ipilimumab (3 mg/kg)

Interventions

  • BiologicalIpilimumab (3 mg/kg)

    Drug page: Ipilimumab

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From trial registration to 3 months post ipilimumab administration

  2. Overall Survival at 12 months post trial registration

    Time frame: From trial registration to 1 year post treatment

  3. Feasibility of neoadjuvant ipilimumab

    The number of patients and percentage of patients completing neoadjuvant ipilimumab regimen will be reported.

    Time frame: Upon the final patient completing treatment

  4. Best overall objective response rate

    Time frame: Through study completion, an average of 14 months

Secondary outcomes

  1. Overall survival at 24 months

    Time frame: From date of registration up to 104 weeks

  2. Progression Free Survival

    Time frame: From date of registration up to date of progression

  3. Surgical Complications

    Time frame: During surgery

  4. 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.

    Time frame: Through treatment completion, an average of 42 days

  5. Changes in Eastern Cooperative Oncology Group performance status

    Time frame: From baseline to end of 12 month follow up

  6. Resection Rate

    Time frame: postprocedural

  7. 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.

    Time frame: Through treatment completion, average of 42 days

  8. 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.

    Time frame: Baseline

  9. 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.

    Time frame: Date of registration to date of surgery

  10. Changes in Health Related Quality of Life (HRQoL) as measure by EORTC QLQ-C30 and QLQ-BN20

    Time frame: Screening to 3 month follow up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07134842
Responsible party
Sponsor
First posted
Aug 21, 2025
Start date
Jul 10, 2025
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Apr 9, 2026

Study contacts

WinGlio Trial Manager
Contact
ctc.winglio@ucl.ac.uk
Paul Mulholland, MBBS, PhD
principal investigator · University College, London

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ipilimumab

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