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.
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
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
Single group
Ipilimumab (3 mg/kg)
Biological/VaccineAll 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.
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
Overall Survival at 12 months post trial registration
Feasibility of neoadjuvant ipilimumab
The number of patients and percentage of patients completing neoadjuvant ipilimumab regimen will be reported.
Best overall objective response rate
Overall survival at 24 months
Progression Free Survival
Surgical Complications
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.
Click on the lead sponsor to view all of their trials.
