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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Window Studies in Glioblastoma: A Phase I Trial Investigating Neoadjuvant Ipilimumab in Newly Diagnosed Glioblastoma

A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment. (NCT07134842) is a Phase 1 interventional studying Glioblastoma and Gliosarcoma, Adult, sponsored by University College, London. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Glioblastoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 16 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Radiologically or diagnosed by tissue sample (biopsy-confirmed), newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma) 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see appendix 3) 4. Clinically fit for, and appropriate to receive, neoadjuvant ipilimumab followed by standard of care treatment, based on investigator and MDT judgement 5. Adequate organ and bone marrow function: - Hb ≥9 g/dL - Neutrophils ≥1.5 x 109/L - platelet count at least 100 x 109/L - Lymphocyte count ≥1.0 x 109/L 6. Adequate renal function: • Creatinine clearance of ≥ 50mL/min calculated by Cockroft-Gault equation 7. 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 8. expected to live at least 12 weeks 9. Willing to comply with the contraceptive 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 willing to sign a consent form Who Should NOT Join This Trial: 1. Known extracranial metastatic or leptomeningeal disease 2. Prior treatment for glioblastoma other than a biopsy 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 autoimmune conditions (where your immune system attacks your own body) 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Radiologically or histologically confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma) 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see appendix 3) 4. Clinically fit for, and appropriate to receive, neoadjuvant ipilimumab followed by standard of care treatment, based on investigator and MDT judgement 5. 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 6. Adequate renal function: • Creatinine clearance of ≥ 50mL/min calculated by Cockroft-Gault equation 7. 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 8. Life expectancy of greater than 12 weeks 9. Willing to comply with the contraceptive 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 informed consent Exclusion Criteria: 1. Known extracranial metastatic or leptomeningeal disease 2. Prior treatment for glioblastoma other than a biopsy 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 autoimmune 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 hypersensitivity to ipilimumab or any of its excipients 9. 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. 10. 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. 11. 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. 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 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. 14. Positive serology for Hepatitis C defined as a positive test for HCV antibody 15. Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy or known HIV 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

Treatments Being Tested

BIOLOGICAL

Ipilimumab (3 mg/kg)

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University College London Hospital
London, Greater London, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07134842), the sponsor (University College, London), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07134842 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07134842?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07134842?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07134842. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07134842. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.