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

Not Applicable

Recruiting

• Conditions: Glioblastoma; Gliosarcoma, Adult; Glioblastoma - Category
• Interventions: Biological: Ipilimumab (3 mg/kg)

• Registration Number: NCT07134842
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-30
• Study Start: 2025-07-10
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Ipilimumab (3 mg/kg)	All patients will be treated with up to two cycles of ipilimumab prior to their standard treatment. Each cycle will last 21 days.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	From trial registration to 3 months post ipilimumab administration	Safety and tolerability of neoadjuvant ipilimumab as assessed by serious and non-serious adverse events, graded according to CTCAE v5.0
Overall Survival at 12 months post trial registration	From trial registration to 1 year post treatment
Feasibility of neoadjuvant ipilimumab	Upon the final patient completing treatment	The number of patients and percentage of patients completing neoadjuvant ipilimumab regimen will be reported.
Best overall objective response rate	Through study completion, an average of 14 months

Secondary Outcome Measures

Name	Time	Method
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	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.
Changes in Eastern Cooperative Oncology Group performance status	From baseline to end of 12 month follow up
Resection Rate	postprocedural
Patient Acceptability	Through treatment completion, average of 42 days	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.
Surgeon Acceptability	Baseline	Surgeon acceptability will be determined by the percentage of eligible patients who are not enrolled in the trial due to a surgeon's decision.
Delay in Surgery	Date of registration to date of 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.
Changes in Health Related Quality of Life (HRQoL) as measure by EORTC QLQ-C30 and QLQ-BN20	Screening to 3 month follow up

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, Greater London, United Kingdom