At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nabiximols (drug), Temozolomide (drug), Nabiximols-matched placebo (drug)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- Nabiximols — drug: Oromucosal spray · Temozolomide — drug: Oral capsule · Nabiximols-matched placebo — drug: Nabiximols-matched placebo oromucosal spray
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 120
- Started
- 2023-02-03
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for glioblastoma
- • Phase2 - 120 participants
- • ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ)
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with glioblastoma
Where?
- • Bodelwyddan - Glan Clwyd Hospital
- • Northwood - Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust
- • Aberdeen - Aberdeen Royal Infirmary, NHS Grampian
- • Belfast - Belfast City Hospital, Belfast Health and Social Care Trust
- • +18 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).
More detail
This is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols (Sativex®) with placebo in patients with recurrent MGMT methylated glioblastoma treated with temozolomide (TMZ). The trial will randomise a target number of 120 patients on a 2:1 basis to receive either Nabiximols or Nabiximols-matched placebo, in combination with standard TMZ. Patients will be followed up at 4-weekly assessments for a minimum of 52 weeks from the start of trial treatment or until death, whichever is sooner. MRI scanning will be performed at screening, week 10, week 22, week 30, then 3-monthly after commencing trial treatment as per standard practice. The trial includes an initial feasibility study of 40 patients to confirm safety, compliance and achievability of planned target recruitment. There are no formal criteria for evaluation of feasibility but once 40 patients have been recruited, the independent Data Monitoring Committee will review the adverse event data, details on protocol treatment received, monthly recruitment rates and projected recruitment in order to make recommendations on trial continuation. The original phase II trial design allowed potential expansion of recruitment into a phase III trial, should the emerging phase II results warrant this development; however, the trial was revised to a standard phase II design to lower the recruitment targets in 2025 The trial will be linked to the Tessa Jowell BRAIN MATRIX (TJBM) programme; utilising TJBM infrastructure, opening the same participating sites, and aligning the data collection and Quality of Life assessments already embedded in TJBM. This collaboration will allow data sharing within the platform thereby streamlining patient entry and provide additional oversight through TJBM. Patients recruited to TJBM who are potentially eligible for ARISTOCRAT may be identified and suggested to sites for consideration to the trial.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ been received
- ✓ side-effects ≤ Grade 2
What the study is looking for
- ✓Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology...
- ✓A minimum of 3 cycles of after surgery TMZ must have been received.
- ✓A minimum of Stable Disease (SD) (or Partial Response (PR)/Complete Response (CR)) at the end of first-line...
- ✓≥3 months since day 28 of the last cycle of TMZ.
- ✓Good overall fitness (Karnofsky 60).
Who cannot take part
- ✗Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
- ✗Prior invasive cancer (except non-melanoma skin cancer), unless disease free for a minimum of one year.
- ✗Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.
- ✗Prior treatment, apart from debulking surgery, for first recurrence of GBM.
- ✗Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.
See the full criteria
Where Is This Study? (22 UK sites)
Glan Clwyd Hospital
Bodelwyddan LL18 5UJ, United Kingdom
Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust
Northwood HA6 2RN, United Kingdom
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen AB25 2ZN, United Kingdom
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast BT9 7AB, United Kingdom
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2TH, United Kingdom
Bristol Haematology & Oncology Centre, University Hospitals Bristol & Weston NHS Foundation Trust
Bristol BS2 8ED, United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff CF15 7QZ, United Kingdom
Western General Hospital, NHS Lothian
Edinburgh EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde
Glasgow G12 0YN, United Kingdom
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Hull HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903St James's University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London EC1A 7BE, United Kingdom
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London W6 8RF, United Kingdom
Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust
Maidstone ME16 9QQ, United Kingdom
The Christie Hospital, The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust
Nottingham NG5 1PB, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford OX3 9DU, United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth PL6 8DH, United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Rhys Mant
Sponsor contactCONTACT
Joshua Savage
Sponsor contactCONTACT
