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