Tumour testing to guide treatment in younger adults with glioblastoma

Trial details

Who runs it

Olivia Newton-John Cancer Research Institute

Trial code

NCT07908147

Record updated

30 October 2026

Original description

This study will investigate whether rapid molecular testing of recurrent glioblastoma (GBM) can identify tumour biomarkers that may help guide treatment selection in younger people with IDH-wildtype GBM. Participants will be people under 55 years of age whose diagnosis is consistent with glioblastoma and who have undergone recent surgery or previously participated in the initial phase of the BRAid GBM study.Read full original descriptionShow less

Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients (BRAid GBM) Pilot Study

This study will investigate whether rapid molecular testing of recurrent glioblastoma (GBM) can identify tumour biomarkers that may help guide treatment selection in younger people with IDH-wildtype GBM. Participants will be people under 55 years of age whose diagnosis is consistent with glioblastoma and who have undergone recent surgery or previously participated in the initial phase of the BRAid GBM study.

Tumour tissue will undergo rapid molecular testing to identify biomarkers that may predict response to specific targeted treatments. Treatment decisions will be informed by the molecular characteristics of each participant's tumour and available evidence for treatments associated with the identified biomarkers.

The study will assess the feasibility and safety of implementing rapid molecular testing across multiple Australian hospitals and whether this approach can provide timely information to support personalised treatment decisions. The study will also explore whether biomarker-guided treatment may provide alternatives to, or reduce the use of, radiotherapy in younger people with glioblastoma, with the potential to reduce long-term treatment-related effects on cognition and quality of life.

Approximately 110 patients will be screened and 12 participants will be recruited from participating hospitals across Australia.

Inclusion: Adult patient who is aged 18-≤55 years of age; Has MRI features consistent with a high-grade glioma; Is planned for standard of care biopsy or surgery to investigate and/or treat this lesion; ECOG 0-1; Provides informed written consent; Aged 18 to ≤55-years of age; Newly diagnosed patient with IDH-wildtype glioblastoma as per WHO 2021, or morphological features consistent with glioblastoma but pending confirmatory NGS or other profiling; ECOG 0-1; Consents to, and has sufficient tissue, for:; IHC for BRAF V600E, pan-TRK and MMR proteins; Further confirmatory NGS for NTRK fusions if pan-TRK IHC is positive; Life expectancy of at least 12 weeks; Newly diagnosed patients with IDH-wildtype glioblastoma as per WHO 2021; Able to provide written informed consent; Aged 18 to ≤55-years of age; ECOG 0-1; Adequate organ function as defined by; Hepatic: total bilirubin ≤2.0 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤1.5 × ULN; Renal: estimated glomerular filtration rate (GFR) ≥60 mL/min; Bone marrow: platelets ≥100 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, haemoglobin ≥9 g/dL; If the patient is a male or female with reproductive potential, the patient is willing to use an approved contraceptive method (e.g., intrauterine device [IUD], birth control pills, or barrier device) during and for three months after discontinuation of study drug; If the patient is a woman of childbearing potential, she has a negative serum pregnancy test within seven days prior to study enrollment; Life expectancy of at least 12 weeks; Patient is on stable or reducing dose of steroid within the first week of study enrolment, not exceeding a dose of dexamethasone 2 mg or equivalent.

Exclusion: Prior radiation or systemic treatment for glioblastoma; Diagnostic biopsy/craniotomy more than 2-weeks prior to study screening such that insufficient time for molecular profiling; Prior radiation or systemic treatment for glioblastoma; Placement of Gliadel wafers or receipt of any other local investigational therapy at the time of surgery; Prior radiation or systemic anti-cancer treatment for glioblastoma or any glioma, including a history of lower grade glioma; Placement of Gliadel wafers or receipt of any other local investigational therapy at the time of surgery; Any significant concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with participation in the study; Clinically significant gastrointestinal disorder that is expected to compromise absorption of oral medication, as determined by the treating physician for those receiving toral therapy; Multi-focal disease not likely to be encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease; Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan; Serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes; Key Eligibility Criteria (Post-Operative Screening); Multi-focal disease not encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease; Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan; Serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes; Key Eligibility Criteria (for patients being offered trial treatment); Multi-focal disease not encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease; Evidence of significant acute intracranial or intra-tumoral haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan as per clinician discretion. (Note: Patients with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are not excluded); Known history of HIV, hepatitis B or hepatitis C; Any serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes; Psychiatric illness or a social situation that would limit compliance with the study procedures requirements; QTc interval > 470 milliseconds on screening ECG; History of another malignancy, except adequately treated non melanoma skin cancer or carcinoma in-situ of the cervix. Patients with prior malignancy are excluded unless they have been disease free for ≥ 2 years; Pregnant or breastfeeding at time of screening.

Key Eligibility Criteria (Pre-Operative Screening).

ClinicalTrials.gov NCT07908147