WinGio
Research type
Research Study
Full title
Window Studies in Glioblastoma: A phase I trial investigating neo-adjuvant ipilimumab in newly diagnosed glioblastoma
IRAS ID
1011194
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Research summary
Glioblastoma is the most common malignant primary brain tumour. Patients with glioblastoma typically only survive 6-10 months after diagnosis. Most patients relapse after initial treatment. Novel treatment interventions are needed urgently to improve clinical outcomes for patients with glioblastoma.
The trial is investigating a drug called ipilimumab. Ipilimumab increases the patient's immune system response and activates a type of white blood cell so that they can multiply and attack cancer cells anywhere in the body.
The trial will investigate whether the addition of ipilimumab prior to the current standard treatment of surgery and/or radiotherapy and chemotherapy, will improve survival in patients with newly diagnosed glioblastoma. The trial will recruit 16 patients (≥18 years) over 18 months.
Patients will be assessed on a weekly basis, and disease assessments (including MRI scans) will be performed after each cycle of ipilimumab. Patient responses and associated MRI scans will be reviewed by a multi disciplinary team (MDT) consisting of oncologists, radiologists and surgeons to determine that it is safe for the patient to continue with trial treatment. On completion of trial treatment patients will have a further disease assessment (including MRI scan) which will be reviewed by the MDT before continuing to standard treatment of debulking surgery if appropriate and chemoradiation.
Patients will receive a maximum of 2 cycles of ipilimumab. One cycle lasts 21 days. After stopping ipilimumab patients will follow the treating hospital's local treatment and visit schedule and then be followed up every 3 months for 2 years and then annually until the last patient entering the study completes their 1 year follow up visit.
The study will be conducted at NHS hospitals and it expected to last 3 years
REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0092
Date of REC Opinion
25 Mar 2025
REC opinion
Further Information Favourable Opinion