A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Be… (NCT07134842) | Clinical Trial Compass
RecruitingPhase 1
A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.
United Kingdom16 participantsStarted 2025-07-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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:
✓. Adequate renal function:
✓. Adequate liver function:
✓. Life expectancy of greater than 12 weeks
Exclusion criteria
✕. Known extracranial metastatic or leptomeningeal disease
✕. Prior treatment for glioblastoma other than a biopsy or limited resection leaving residual disease
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From trial registration to 3 months post ipilimumab administration
2
Overall Survival at 12 months post trial registration
Timeframe: From trial registration to 1 year post treatment
3
Feasibility of neoadjuvant ipilimumab
Timeframe: Upon the final patient completing treatment
4
Best overall objective response rate
Timeframe: Through study completion, an average of 14 months