GlioblastomaPhase 2ARISTOCRATNCT05629702
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
A Phase 2 study testing Nabiximols and Temozolomide in people with Glioblastoma and Brain Tumor, run by University of Birmingham at 17 sites in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Glioblastoma, Brain Tumor, Cannabis
- What is being tested?
- Nabiximols and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 3 Feb 2023to 7 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required).
- First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence and not pseudo-progression. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment.
- Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in consultation with the ARISTOCRAT Trial Office) with concomitant and adjuvant TMZ.
- A minimum of 3 cycles of adjuvant TMZ must have been received.
- A minimum of Stable Disease (SD) (or Partial Response (PR)/Complete Response (CR)) at the end of first-line treatment (measured by Response Assessment for Neuro-Oncology (RANO) criteria).
- ≥3 months since day 28 of the last cycle of TMZ.
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- Karnofsky Performance Status ≥60.
- Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- Serum creatinine clearance (measured or calculated (using local standard practice)) >30ml/min
- Total serum bilirubin ≤1.5 x upper limit of normal (ULN)
- Liver transaminases <2.5 x ULN
- If surgery has been performed for first recurrence, then the wound must be adequately healed and there must be residual enhancing disease on MRI within 21 days of surgery or new enhancement at later follow up deemed suitable for systemic treatment.
- Recovered from previous treatment side-effects ≤ Grade 2.
- If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids.
- Willing and able to provide trial-specific informed consent.
- Willing and able to comply with trial requirements.
- Age ≥16.
- Able to start treatment within 28 days of randomisation.
Who cannot join
- Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
- Prior invasive malignancy (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.
- Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition.
Show all 20Show fewer
- Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment.
- Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and/or unwilling to abstain for the duration of the trial.
- Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment.
- o Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation.
- Men who are sexually active and unwilling/unable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment.
- Contra-indication to MRI or gadolinium.
- Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Known hypersensitivity to cannabinoids or excipients of the IMP.
- Known history of current or prior alcohol or drug dependence.
- Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection.
- Has received a live vaccine within 28 days prior to randomisation.
- Unable to administer oromucosal medication due to mucosal lesions or other issues.
- Participation in another therapeutic clinical trial whilst taking part in this trial.
- Any psychological, familial, sociological or geographical condition hampering protocol compliance.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, AB25 2ZN
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Bristol Haematology & Oncology Centre, University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, BS2 8ED
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, CF15 7QZ
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Hull, HU16 5JQ
St James's University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
St Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, W6 8RF
Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust
Maidstone, ME16 9QQ
The Christie Hospital, The Christie NHS Foundation Trust
Manchester, M20 4BX
Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY
Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust
Northwood, Middlesex, HA6 2RN
City Hospital, Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
About this study
Official title: A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma
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).
Read the detailed description
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.
- Conditions
- Glioblastoma, Brain Tumor, Cannabis, Brain Tumor, Recurrent
- Being tested
- Nabiximols, Temozolomide, Nabiximols-matched placebo
- Keywords
- cannabinoid, GBM, temozolomide, sativex, nabiximols, cannabis, glioblastoma, brain, recurrent
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Marijuana Abuse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiximolsDrug
Also called Sativex
Oromucosal spray
TemozolomideDrug
Oral capsule
Nabiximols-matched placeboDrug
Nabiximols-matched placebo oromucosal spray
| Study group | Role | What they receive |
|---|---|---|
| Standard Temozolomide with Nabiximols | Experimental | * Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles.
* Nabiximols up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1. Receives: Drug: Nabiximols; Drug: Temozolomide |
| Standard Temozolomide with Nabiximols-matched placebo | Placebo comparator | * Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles.
* Nabiximols-matched placebo up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1. Receives: Drug: Temozolomide; Drug: Nabiximols-matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time (OS)
To establish whether the addition of cannabinoids (Nabiximols) to standard TMZ treatment improves overall survival time (OS) in MGMT methylated recurrent GBM compared to the addition of placebo to TMZ.
Measured: Time in whole days from date of randomisation to the date of death from any cause, assessed at a minimum of 12 months..
Secondary outcomes (4)
Overall survival at 12 months (OS12) (and 6 and 24 months)
Of particular clinical relevance is the overall survival at 12 months from date of randomisation, i.e. whether the participant is alive or not at that time point. Overall survival at 6 months and 24 months will also be of interest.
Measured: 6, 12 and 24 months
Progression-free survival time (PFS)
Measured using Response Assessment for Neuro-Oncology (RANO) criteria at screening, weeks 10, 22, 30 then 3 monthly (as per standard of care) for up to a minimum of 52 weeks from the start of trial treatment. PFS includes radiological progression assessed in accordance with RANO criteria and clinical progression where radiological progression is not possible.
Measured: Time in whole days from the date of randomisation to the date of the first documented evidence of disease progression or death (from any cause), whichever came first, assessed at a minimum of 12 months.
Health-related quality of life (HRQoL) as assessed by EORTC QLQ-C30
Generic Health-related quality of life (HRQoL) will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) consisting of function, symptom and global health status scales, scored 1-4 with lower scores indicating better outcomes..
Measured: Baseline (Week 0), Week 8, Week 16, End of Treatment (Week 24)
Adverse events
Assessment of AEs according to the current NCI-CTCAE v5.0 criteria. Acute AE will be defined as those occurring up to 12 weeks post-end of treatment. Late AE will be defined as those occurring after 12 weeks post-end of treatment. The end of treatment will be the date of the final chemotherapy cycle.
Measured: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20, End of Treatment (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start3 Feb 2023
- Primary completion7 Oct 2027 (estimated)
- Study completion7 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, The Brain Tumour Charity, Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Fiona Collinson, MBBS, BSc, MRCP, FRCR, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629702
- Sponsor's protocol ID
- RG_21-001
- Other IDs
- 2021-005214-34, ISRCTN
- Acronym
- ARISTOCRAT
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientifically sound proposals from appropriately qualified researchers will be considered for data sharing. Requests should be made by returning a Data Sharing Request Form to newbusiness@trials.bham.ac.uk; this captures the research requirements, statistical analysis plan, and intended publication schedule. Requests will be reviewed by the Cancer Research UK Clinical Trials Unit (CRCTU) Directors in discussion with the Chief Investigator (CI), Trial Management Group (TMG) and independent Trial Steering Committee (TSC). They will consider the scientific validity of the request, qualifications of the researchers, views of CI, TMG and TSC, consent arrangements, practicality of anonymizing the requested data contractual obligations. If supportive of the request, and where not already obtained, Sponsor consent for data transfer will be sought before notifying applicants of the outcome. It is anticipated that applicants will be notified within 3 months of receipt of the original request.
Publications
Bhaskaran D, Savage J, Patel A, Collinson F, Mant R, Boele F, Brazil L, Meade S, Buckle P, Lax S, Billingham L, Short SC. A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial. BMC Cancer. 2024 Jan 15;24(1):83. doi: 10.1186/s12885-023-11792-4.
PubMed 38225549
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT05629702
- Acronym / sponsor ID
- ARISTOCRAT / RG_21-001
- Conditions
- Glioblastoma, Brain Tumor, Cannabis, Brain Tumor, Recurrent
- Keywords
- cannabinoid, GBM, temozolomide, sativex, nabiximols, cannabis, glioblastoma, brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University of Leeds, The Brain Tumour Charity, Jazz Pharmaceuticals
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 7 Oct 2027 (estimated)
- Study completion
- 7 Oct 2027 (estimated)
- First posted
- 29 Nov 2022 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Temozolomide with Nabiximols | Experimental | Drug: Nabiximols, Drug: Temozolomide* Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles. * Nabiximols up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1. |
| Standard Temozolomide with Nabiximols-matched placebo | Placebo comparator | Drug: Temozolomide, Drug: Nabiximols-matched placebo* Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles. * Nabiximols-matched placebo up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required).
- First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence and not pseudo-progression. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment.
- Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in consultation with the ARISTOCRAT Trial Office) with concomitant and adjuvant TMZ.
- ≥3 months since day 28 of the last cycle of TMZ.
- Karnofsky Performance Status ≥60.
Key exclusion criteria (20 listed)
- Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
- Prior invasive malignancy (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.
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 |
|---|---|---|
| NabiximolsAlso: SativexOromucosal spray | Drug | Standard Temozolomide with Nabiximols |
| TemozolomideOral capsule | Drug | Standard Temozolomide with Nabiximols, Standard Temozolomide with Nabiximols-matched placebo |
| Nabiximols-matched placeboNabiximols-matched placebo oromucosal spray | Drug | Standard Temozolomide with Nabiximols-matched placebo |
Primary outcome
Overall survival time (OS)
Time frame: Time in whole days from date of randomisation to the date of death from any cause, assessed at a minimum of 12 months..
To establish whether the addition of cannabinoids (Nabiximols) to standard TMZ treatment improves overall survival time (OS) in MGMT methylated recurrent GBM compared to the addition of placebo to TMZ.
4 secondary outcomes
Overall survival at 12 months (OS12) (and 6 and 24 months)
Time frame: 6, 12 and 24 months
Progression-free survival time (PFS)
Time frame: Time in whole days from the date of randomisation to the date of the first documented evidence of disease progression or death (from any cause), whichever came first, assessed at a minimum of 12 months.
Health-related quality of life (HRQoL) as assessed by EORTC QLQ-C30
Time frame: Baseline (Week 0), Week 8, Week 16, End of Treatment (Week 24)
Adverse events
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20, End of Treatment (Week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 38225549Bhaskaran D, Savage J, Patel A, Collinson F, Mant R, Boele F, Brazil L, Meade S, Buckle P, Lax S, Billingham L, Short SC. A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial. BMC Cancer. 2024 Jan 15;24(1):83. doi: 10.1186/s12885-023-11792-4.
- Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Scientifically sound proposals from appropriately qualified researchers will be considered for data sharing. Requests should be made by returning a Data Sharing Request Form to newbusiness@trials.bham.ac.uk; this captures the research requirements, statistical analysis plan, and intended publication schedule. Requests will be reviewed by the Cancer Research UK Clinical Trials Unit (CRCTU) Directors in discussion with the Chief Investigator (CI), Trial Management Group (TMG) and independent Trial Steering Committee (TSC). They will consider the scientific validity of the request, qualifications of the researchers, views of CI, TMG and TSC, consent arrangements, practicality of anonymizing the requested data contractual obligations. If supportive of the request, and where not already obtained, Sponsor consent for data transfer will be sought before notifying applicants of the outcome. It is anticipated that applicants will be notified within 3 months of receipt of the original request.
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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.
Fiona Collinson, MBBS, BSc, MRCP, FRCR, PhD principal investigator
University of Leeds
17 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 Nabiximols and Temozolomide in people with Glioblastoma and Brain Tumor, run by University of Birmingham at 17 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 20 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival time (OS) (time frame: Time in whole days from date of randomisation to the date of death from any cause, assessed at a minimum of 12 months..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629702, which also lists 1 linked publication.
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 16 Oct 2026.