OncoMatch

OncoMatch/Clinical Trials/NCT05929495

Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma

Is NCT05929495 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Metformin for glioblastoma, idh-wildtype.

Phase 2RecruitingUniversity of Milano BicoccaNCT05929495Data as of May 2026

Treatment: MetforminAbout 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. This is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months. The clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.

Check if I qualify

Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 wild-type

IDH wild type

Allowed: MGMT hypomethylation

hypomethylation or hypermethylation of MGMT assessed post-surgery

Allowed: MGMT hypermethylation

hypomethylation or hypermethylation of MGMT assessed post-surgery

Disease stage

Required: Stage IV (WHO)

Grade: IV (WHO)

WHO grade IV, IDH wild type

Prior therapy

No prior treatment (treatment-naive required)

Must have received: surgical resection

undergoing surgical resection

Must have received: Stupp protocol

Patients undergoing Stupp protocol including patients aged > 70 years performing the hypofractionated protocol and three weeks of chemotherapy

Cannot have received: metformin (metformin)

taking metformin, insulin or other biguanides, regardless of the reason

Cannot have received: insulin (insulin)

taking metformin, insulin or other biguanides, regardless of the reason

Cannot have received: biguanide

taking metformin, insulin or other biguanides, regardless of the reason

Lab requirements

Kidney function

impaired renal function with creatinine clearance < 60 mL/min assessed at recruitment

Liver function

liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use

Impaired renal function with creatinine clearance < 60 mL/min assessed at recruitment, liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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 qualify