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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
University College London Hospital
London, Greater London, United Kingdom
RECRUITINGIncidence 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
Time frame: From trial registration to 3 months post ipilimumab administration
Overall Survival at 12 months post trial registration
Time frame: 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.
Time frame: Upon the final patient completing treatment
Best overall objective response rate
Time frame: Through study completion, an average of 14 months
Overall survival at 24 months
Time frame: From date of registration up to 104 weeks
Progression Free Survival
Time frame: From date of registration up to date of progression
Surgical Complications
Time frame: During surgery
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.
Time frame: Through treatment completion, an average of 42 days
Changes in Eastern Cooperative Oncology Group performance status
Time frame: From baseline to end of 12 month follow up
Resection Rate
Time frame: postprocedural
Patient Acceptability
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.
Time frame: Through treatment completion, average of 42 days
Surgeon Acceptability
Surgeon acceptability will be determined by the percentage of eligible patients who are not enrolled in the trial due to a surgeon's decision.
Time frame: Baseline
Delay in 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.
Time frame: Date of registration to date of surgery
Changes in Health Related Quality of Life (HRQoL) as measure by EORTC QLQ-C30 and QLQ-BN20
Time frame: Screening to 3 month follow up
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