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

NCT07134842 | Recruiting Phase 1 DMC

• 1 other identifier: UCL/176169
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma; Gliosarcoma, Adult; Glioblastoma - Category

Keywords

phase 1; immunotherapy; Brain Cancer; Glioblastoma

Outcome Measures

Primary Outcomes (4)

• 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

  From trial registration to 3 months post ipilimumab administration

• Overall Survival at 12 months post trial registration

  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.

  Upon the final patient completing treatment

• Best overall objective response rate

  Through study completion, an average of 14 months

Secondary Outcomes (10)

• Overall survival at 24 months

  From date of registration up to 104 weeks

• Progression Free Survival

  From date of registration up to date of progression

• Surgical Complications

  During surgery

• Treatment Compliance

  Through treatment completion, an average of 42 days

• Changes in Eastern Cooperative Oncology Group performance status

  From baseline to end of 12 month follow up

Study Arms (1)

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.

Biological: Ipilimumab (3 mg/kg)

Interventions

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, Greater London, NW1 2PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Paul Mulholland, MBBS, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WinGlio Trial Manager

CONTACT

ctc.winglio@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: August 21, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)