NeAT Glio
Research type
Research Study
Full title
A Phase II Trial of Neoadjuvant Therapy in Patients with Newly Diagnosed Glioblastoma
IRAS ID
291628
Contact name
Paul Mulholland
Contact email
Sponsor organisation
University College London
Eudract number
2020-004902-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Summary of Research
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 followed by radiotherapy and chemotherapy, will improve survival in patients with newly diagnosed glioblastoma. The trial will recruit 43 patients (≥18 years) over 1 year.
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 multidisciplinary team (MDT) consisting of oncologists, radiologists and surgeons to determine if the patient should 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 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 2 year follow up visit.
The study will be conducted at NHS hospitals and it expected to last 3 years 6 months.
Summary of Results
The NeAT Glio trial was a single-arm single-stage phase II trial to evaluate whether the addition of ipilimumab prior to the current standard of care of surgery and chemoradiotherapy would improve survival in patients with newly diagnosed glioblastoma. The trial was looking to recruit 43 patients from 20 UK sites.
Consenting eligible patients with newly diagnosed de-novo glioblastoma were to be recruited to the study to receive a maximum of 2 cycles of ipilimumab, administered intravenously at a dose of 3mg/kg on day 1 of each 21 day cycle.
The trial was opened to recruitment on the 24th August 2022 and subsequently recruited a single patient across 4 open sites.
The patient received one cycle of ipilimumab and then treatment stopped because the patient was hospitalised with a grade 3 adverse event. The patient had no further protocol-specified visits after the hospital admission and no response assessment performed within the trial.
On the 24th May 2023 Bristol Myers Squibb, who were providing the ipilimumab (IMP) free of charge for the trial, informed the Sponsor that they were withdrawing their support for the trial.
The Trial Management Group assessed the possibility of keeping the trial open, including other investigational agents, but unfortunately no agents would have been available in a feasible timeframe. There were also concerns over the feasibility of the trial because the Sponsor were unable to open the required 20 sites. This was partly as a result of resource issues at sites and in addition to this a lack of engagement from sites where clinical teams were unwilling to delay surgery in order to deliver the ipilimumab. At the sites that were open, patients themselves either didn’t want to delay surgery, or the clinical team didn’t and therefore eligible patients were not approached.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0860
Date of REC Opinion
14 Dec 2021
REC opinion
Further Information Favourable Opinion