OncoMatch/Clinical Trials/NCT05629702
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
Is NCT05629702 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Nabiximols and Temozolomide for glioblastoma.
Treatment: Nabiximols · Temozolomide — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT promoter methylation
MGMT promoter methylated
Required: IDH1 wild-type
IDH wild type (WT)
Required: IDH2 wild-type
IDH wild type (WT)
Excluded: BRAF mutation
patients with molecular features of PXA or BRAF mutation will be excluded
Demographics
Prior therapy
Must have received: radiation therapy — first-line
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
Must have received: alkylating agent (temozolomide) — first-line
concomitant and adjuvant TMZ
Cannot have received: stereotactic radiotherapy
Prior treatment with stereotactic radiotherapy
Cannot have received: brachytherapy
Prior treatment with...brachytherapy
Cannot have received: Convection Enhanced Delivery
Prior treatment with...Convection Enhanced Delivery (CED) of any agent
Cannot have received: systemic therapy
Exception: apart from debulking surgery
Prior treatment, apart from debulking surgery, for first recurrence of GBM
Cannot have received: temozolomide (temozolomide)
Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L
Kidney function
Serum creatinine clearance >30ml/min
Liver function
Total serum bilirubin ≤1.5 x upper limit of normal (ULN); Liver transaminases <2.5 x ULN
Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation: * Absolute neutrophil count (ANC) ≥1.5 x 10^9/L * Platelet count ≥100 x 10^9/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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05629702 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior stereotactic radiotherapy, brachytherapy, Convection Enhanced Delivery disqualifies patients from enrollment.
Does this trial require MGMT?
Yes, MGMT promoter methylation is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 wild-type is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages