GlioblastomaPhase 2NeAT GlioNCT05074992
A Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
A Phase 2 study testing Ipilimumab in people with Glioblastoma, run by University College, London at 4 sites in United Kingdom.
Trial summary
The NeAT Glio trial will evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 24 Aug 2022to 2 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma)
- Age ≥18 years
- Tumour deemed appropriate for surgical debulking
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Clinically fit for, and appropriate to receive, neoadjuvant ipilimumab followed by standard of care treatment, based on investigator and MDT judgement
- Adequate organ and bone marrow function: Hb ≥9 g/dL, neutrophils ≥1.0 x 10 9/L, platelets ≥100 x 10 9/L and lymphocyte count ≥1.0 x 10 9/L
Show all 15Show fewer
- Adequate renal function: < 1.5 x ULN or a creatinine clearance of ≥ 50mL/min calculated by Cockroft-Gault equation
- Adequate liver function, including:
- Bilirubin ≤ 1.5 x ULN (except for patients with known Gilbert's Syndrome who may have total bilirubin ≤ 3 x ULN)
- Aspartate or alanine transferase (AST or ALT) ≤ 2.5 x ULN
- Life expectancy of greater than 12 weeks
- Willing to comply with the contraceptive requirements of the trial
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Willing to donate tumour material and serial blood samples
- Written informed consent
Who cannot join
- Diagnosis of Multifocal glioblastoma (Multicentric glioblastoma permitted)
- Prior resection of glioblastoma leaving inadequate tissue for post investigational treatment resection
- Secondary glioblastoma (i.e. previous histological or radiological diagnosis of lower grade glioma)
- Known extracranial metastatic or leptomeningeal disease
- Prior treatment for glioblastoma other than a limited resection or biopsy
- Dexamethasone dose >3mg daily (or equivalent) at the time of starting study treatment
Show all 22Show fewer
- Antibiotics within 30 days of starting study treatment
- Intratumoural or peritumoural haemorrhage deemed significant by the treating physician
- Active autoimmune disease apart from:
- Skin conditions such as psoriasis, vitiligo or alopecia not requiring systemic treatment
- Type 1 diabetes or thyroid disease, controlled on medication
- Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Known hypersensitivity to ipilimumab or any of its excipients
- Past medical history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced interstitial disease which required steroid treatment or any evidence of clinically active interstitial lung disease
- Any condition requiring systemic treatment with corticosteroids (>10mg prednisolone daily or equivalent) or other immunosuppressive medications within 14 days of starting study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10mg daily prednisolone or equivalent are permitted in the absence of active autoimmune disease
- Treatment with any other investigational agent within 28 days prior to starting study treatment
- History of previous cancer within 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions
- Positive serology for Hepatitis B defined as a positive test for HepB surface antigen (HBsAg). Note: patients who are HepB core antibody (HBcAb) positive will only be eligible for the study if the HepB virus deoxyribonucleic acid (DNA) test is negative and patients are willing to undergo monthly monitoring for Hepatitis B virus reactivation
- Positive serology for Hepatitis C defined as a positive test for Hepatitis C virus antibody
- Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy or known HIV or acquired immunodeficiency syndrome (AIDS)-related illness
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Women who are pregnant or breast feeding
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen
St Bartholomew's Hospital
London
University College London Hospital
London
Queen's Hospital
Romford
About this study
Official title: A Phase II Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
The NeAT Glio trial will evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma.
Read the detailed description
This is a phase II trial to evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma.
The trial will recruit 43 patients over 1 year.
Trial Subjects (patients) with newly diagnosed de-novo glioblastoma who are deemed eligible for the trial will be recruited to the study to receive neoadjuvant ipilimumab. Patients will receive 2 cycles of ipilimumab, administered intravenously at a dose of 3mg/kg on day 1 of each 21 day cycle.
Prior to trial entry the patient's treating multidisciplinary team (MDT) consisting of oncologists, radiologists and surgeons must agree that the patient is a suitable candidate for ipilimumab prior to surgery and that surgery may be delayed beyond usual standard of care timelines.
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 the MDT 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 with the MDT before continuing to standard of care treatment of debulking surgery and chemoradiation.
Patients demonstrating clinical or radiological deterioration (as determined by the MDT or the principal investigator) at any point, either before starting or whilst receiving ipilimumab, will stop trial treatment and proceed to debulking surgery and chemoradiotherapy as per local policies.
Patients will be followed up every 3 months for 2 years and then annually thereafter.
End of trial will be declared when the final data item for the final patient is received i.e. when the final patient completes their 2 year follow up visit.
- Conditions
- Glioblastoma
- Being tested
- Ipilimumab
- Keywords
- Newly Diagnosed
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Ipilimumab is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab | Experimental | 3mg/kg Ipilimumab IV infusion (day 1) given as a 21 day cycle for 2 cycles. Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate at 24 months
Number of patients alive at 24 months
Measured: 24 months after diagnostic biopsy
Secondary outcomes (8)
Survival rate at 12 months
Number of patients alive at 12 months
Measured: 12 months after diagnostic biopsy
Time to treatment failure
Time from 1st diagnostic biopsy to early treatment discontinuation, progression, starting further treatment or death
Measured: 1st diagnostic biopsy to early treatment discontinuation, progression, starting further treatment or death up to 24 months
Best Overall Objective Response Rate
Number of patients who experienced a Complete Response (CR), Partial Response (PR), Minor Response (MR) or Stable Disease (SD)
Measured: After ipilimumab treatment through to study completion, an average of 36 months
Treatment emergent adverse events
Adverse events being report during and after treatment, coded using CTCAE v5.0
Measured: From start of treatment until 3 months post administration of ipilimumab
Treatment Compliance
Median time on treatment for all patients
Measured: From start of treatment until treatment discontinuation, an average of 2 months
Changes in Performance Status
Percentages of World Health Organisation (WHO) performance status will be measured
Measured: From screening through to study completion, an average of 3 years
Surgical complications
Each type of surgical complication and worst severity grade will be reported, coded using CTCAE v5.0 for patients that undergo surgery
Measured: From surgery through to study completion, an average of 3 years
Resection rate
Number of patients who had no surgery, achieved subtotal resection and achieved gross total resection
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start24 Aug 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Why it stopped: Support withdrawn from drug company supplying IMP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Paul Mulholland, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074992
- Sponsor's protocol ID
- UCL/134643
- Acronym
- NeAT Glio
- Status last verified
- May 2024
- First submitted
- 25 Jun 2021
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT05074992
- Acronym / sponsor ID
- NeAT Glio / UCL/134643
- Conditions
- Glioblastoma
- Keywords
- Newly Diagnosed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Support withdrawn from drug company supplying IMP
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NeAT Glio trial will evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma.
Detailed description
This is a phase II trial to evaluate whether the addition of ipilimumab prior to the current standard treatment of surgery and chemoradiotherapy will improve survival in patients with newly diagnosed glioblastoma.
The trial will recruit 43 patients over 1 year.
Trial Subjects (patients) with newly diagnosed de-novo glioblastoma who are deemed eligible for the trial will be recruited to the study to receive neoadjuvant ipilimumab. Patients will receive 2 cycles of ipilimumab, administered intravenously at a dose of 3mg/kg on day 1 of each 21 day cycle.
Prior to trial entry the patient's treating multidisciplinary team (MDT) consisting of oncologists, radiologists and surgeons must agree that the patient is a suitable candidate for ipilimumab prior to surgery and that surgery may be delayed beyond usual standard of care timelines.
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 the MDT 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 with the MDT before continuing to standard of care treatment of debulking surgery and chemoradiation.
Patients demonstrating clinical or radiological deterioration (as determined by the MDT or the principal investigator) at any point, either before starting or whilst receiving ipilimumab, will stop trial treatment and proceed to debulking surgery and chemoradiotherapy as per local policies.
Patients will be followed up every 3 months for 2 years and then annually thereafter.
End of trial will be declared when the final data item for the final patient is received i.e. when the final patient completes their 2 year follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab | Experimental | Drug: Ipilimumab3mg/kg Ipilimumab IV infusion (day 1) given as a 21 day cycle for 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma)
- Age ≥18 years
- Tumour deemed appropriate for surgical debulking
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Clinically fit for, and appropriate to receive, neoadjuvant ipilimumab followed by standard of care treatment, based on investigator and MDT judgement
Key exclusion criteria (22 listed)
- Diagnosis of Multifocal glioblastoma (Multicentric glioblastoma permitted)
- Prior resection of glioblastoma leaving inadequate tissue for post investigational treatment resection
- Secondary glioblastoma (i.e. previous histological or radiological diagnosis of lower grade glioma)
- Known extracranial metastatic or leptomeningeal disease
- Prior treatment for glioblastoma other than a limited resection or biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabIpilimumab is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. | Drug | Ipilimumab |
Primary outcome
Survival rate at 24 months
Time frame: 24 months after diagnostic biopsy
Number of patients alive at 24 months
8 secondary outcomes
Survival rate at 12 months
Time frame: 12 months after diagnostic biopsy
Time to treatment failure
Time frame: 1st diagnostic biopsy to early treatment discontinuation, progression, starting further treatment or death up to 24 months
Best Overall Objective Response Rate
Time frame: After ipilimumab treatment through to study completion, an average of 36 months
Treatment emergent adverse events
Time frame: From start of treatment until 3 months post administration of ipilimumab
Treatment Compliance
Time frame: From start of treatment until treatment discontinuation, an average of 2 months
Changes in Performance Status
Time frame: From screening through to study completion, an average of 3 years
Surgical complications
Time frame: From surgery through to study completion, an average of 3 years
Resection rate
Time frame: At the time of surgery
Results and safety
The study was stopped early (reason given: Support withdrawn from drug company supplying IMP). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Mulholland principal investigator
University College London Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab in people with Glioblastoma, run by University College, London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Support withdrawn from drug company supplying IMP). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate at 24 months (time frame: 24 months after diagnostic biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.