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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07908147




Registration number
Help: Registration number
NCT07908147
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
14/10/2026
Date registered
Help: Date registered
30/10/2026
Date last updated
Help: Date last updated
30/10/2026

Titles & IDs
Public title
Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients - Pilot Study
Scientific title
Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients (BRAid GBM) Pilot Study
Additional trial identifiers [1] 0 0
ONJ2026-002
Universal Trial Number (UTN)
Trial acronym
BRAid GBM
Related trial records

Health condition
Health condition(s) studied:
IDH Wildtype Glioblastoma 0 0
Glioblastoma (GBM) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - Larotrectinib
Treatment: Drugs - Cadonilimab
Treatment: Drugs - Plixorafenib

Experimental: BRAF-altered - Plixorafenib 900 mg orally once daily continuously

Experimental: NTRK fusion-positive - Larotrectinib 100 mg orally twice daily continuously

Experimental: Mismatch repair deficient - Cadonilimab 6 mg/kg intravenously on Days 1 and 15


Treatment: Drugs: Larotrectinib
Larotrectinib is a first-in-class, highly selective, oral inhibitor of the tropomyosin receptor kinase (TRK) family of proteins (TRKA, TRKB and TRKC).

Treatment: Drugs: Cadonilimab
AK104 is bispecific IgG single chain Fv fragment (ScFv) monoclonal antibody that binds to human programmed cell death 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)

Treatment: Drugs: Plixorafenib
Plixorafenib is a next generation, orally available, small-molecule, selective inhibitor of Class 1 and 2 mutated BRAF.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of Rapid Molecular Profiling and Matched Targeted Therapy
Timepoint [1] 0 0
From enrollment to initiation of chemoradiation (pre-treatment period).
Secondary outcome [1] 0 0
Number and Percentage of Participants Experiencing Adverse Events by CTCAE Grade
Timepoint [1] 0 0
From Cycle 1 Day 1 (each cycle is 28 days) until 30 days after the end of study treatment.
Secondary outcome [2] 0 0
Efficacy of Induction Targeted Therapy in Newly Diagnosed Glioblastoma
Timepoint [2] 0 0
From Cycle 1 Day 1 (each cycle is 28 days) until the commencement of the next anti-cancer intervention or death from any cause, whichever occurs first.
Secondary outcome [3] 0 0
Change in Quality of Life Scores as Assessed by the EORTC QLQ-C30 Questionarrie
Timepoint [3] 0 0
From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months.
Secondary outcome [4] 0 0
Change in Learning and Memory Scores as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R)
Timepoint [4] 0 0
At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Secondary outcome [5] 0 0
Change in Quality of Life Scores as Assessed by the EORTC QLQ-BN20 Questionarrie
Timepoint [5] 0 0
From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months.
Secondary outcome [6] 0 0
Change in Attention and Working Memory Scores as Assessed by the Wechsler Adult Intelligence Scale Digit Span Test
Timepoint [6] 0 0
At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Secondary outcome [7] 0 0
Change in Processing Speed as Assessed by Trail Making Test Part A
Timepoint [7] 0 0
At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Secondary outcome [8] 0 0
Change in Executive Function as Assessed by Verbal Fluency and Trail Making Test Part B
Timepoint [8] 0 0
At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.

Eligibility
Key inclusion criteria
Key Eligibility Criteria (Pre-Operative Screening)



1. Adult patient who is aged 18-=55 years of age
2. Has MRI features consistent with a high-grade glioma
3. Is planned for standard of care biopsy or surgery to investigate and/or treat this lesion
4. ECOG 0-1
5. Provides informed written consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Prior radiation or systemic treatment for glioblastoma
2. Multi-focal disease not likely to be encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
3. Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan.
4. Serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes.

Key Eligibility Criteria (Post-Operative Screening)

Inclusion Criteria:

1. Aged 18 to =55-years of age
2. Newly diagnosed patient with IDH-wildtype glioblastoma as per WHO 2021, or morphological features consistent with glioblastoma but pending confirmatory NGS or other profiling
3. ECOG 0-1
4. Consents to, and has sufficient tissue, for:
5. IHC for BRAF V600E, pan-TRK and MMR proteins
6. Further confirmatory NGS for NTRK fusions if pan-TRK IHC is positive
7. Life expectancy of at least 12 weeks



1. Diagnostic biopsy/craniotomy more than 2-weeks prior to study screening such that insufficient time for molecular profiling
2. Prior radiation or systemic treatment for glioblastoma
3. Placement of Gliadel wafers or receipt of any other local investigational therapy at the time of surgery
4. Multi-focal disease not encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
5. Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan
6. 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)

Inclusion Criteria:

1. Newly diagnosed patients with IDH-wildtype glioblastoma as per WHO 2021
2. Able to provide written informed consent
3. Aged 18 to =55-years of age
4. ECOG 0-1
5. Adequate organ function as defined by

1. Hepatic: total bilirubin =2.0 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) =1.5 × ULN
2. Renal: estimated glomerular filtration rate (GFR) =60 mL/min
3. Bone marrow: platelets =100 × 109/L, absolute neutrophil count (ANC) =1.5 × 109/L, haemoglobin =9 g/dL
6. 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
7. If the patient is a woman of childbearing potential, she has a negative serum pregnancy test within seven days prior to study enrollment
8. Life expectancy of at least 12 weeks
9. 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



1. Prior radiation or systemic anti-cancer treatment for glioblastoma or any glioma, including a history of lower grade glioma
2. Placement of Gliadel wafers or receipt of any other local investigational therapy at the time of surgery
3. Multi-focal disease not encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
4. 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).
5. Pregnant or breastfeeding at time of screening
6. Any significant concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with participation in the study
7. 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
8. Known history of HIV, hepatitis B or hepatitis C
9. Clinically significant gastrointestinal disorder that is expected to compromise absorption of oral medication, as determined by the treating physician for those receiving toral therapy
10. Any serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes
11. Psychiatric illness or a social situation that would limit compliance with the study procedures requirements
12. QTc interval > 470 milliseconds on screening ECG

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2027
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Olivia Newton-John Cancer Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Fore Biotherapeutics
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Akesobio Australia Pty Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hui Gan, MBBS, FRACP
Address 0 0
Olivia Newton-John Cancer Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Project Manager
Address 0 0
Country 0 0
Phone 0 0
+61 3 94969369
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing to occur at publication.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07908147