GBMPhase 1NCT07909811
Novel endOvascular Therapy With beVAcizumab and Cannabinoids for Glioblastoma
A Phase 1 study testing Bevacizumab in people with GBM, run by Unity Health Toronto.
Trial summary
The goal of this clinical trial is to learn if a combined treatment of bevacizumab delivered directly to the brain tumour and a cannabis-based oral spray (nabiximols) can be given safely and practically alongside standard radiation and chemotherapy in adults with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GBM
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2028
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent and able to give informed consent Aged 18 years or older Histopathological confirmation of glioblastoma (WHO 2021) via biopsy or maximal safe resection KPS ≥70 Estimated life expectancy of at least 3 months Agreement to use effective contraception Adequate baseline laboratory values
Who cannot join
- Previous treatment with bevacizumab; pregnancy or lactation Serious cardiovascular disease, clinically significant heart failure, or uncontrolled hypertension (≥150/100 mmHg despite therapy) Intracranial hemorrhage (history, Grade ≥2 on baseline MRI, or active bleeding); bleeding diathesis; anticoagulation or dual antiplatelet therapy that cannot be safely interrupted Arterial thromboembolic event within 6 months; venous thromboembolism within 3 months Major surgery or significant trauma within 28 days (the qualifying biopsy or resection is exempt), or an unhealed wound Gastrointestinal perforation, fistula or abscess within 6 months; nephrotic syndrome; significant renal impairment Arterial pathology precluding safe super-selective catheterization Hypersensitivity to bevacizumab, nabiximols, mannitol or (unmanageable) iodinated contrast Personal or first-degree family history of schizophrenia or other psychotic disorder Potent CYP3A4 or CYP2C9 inhibitors or inducers; nephrotoxic or neurotoxic agents that cannot be withheld Well-established anuria due to severe renal disease, or requirement for renal replacement therapy.
- Severe dehydration or hypovolemia that has not been corrected prior to the procedure.
- Pre-existing plasma hyperosmolarity, defined as serum osmolality > 320 mOsm/kg. Clinically significant, uncorrected electrolyte or acid-base disturbance, including serum sodium outside 130-150 mmol/L or serum potassium outside 3.0-5.5 mmol/L.
- Any other significant intercurrent medical or psychiatric condition that, in the judgement of the investigator, would place the patient at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if a combined treatment of bevacizumab delivered directly to the brain tumour and a cannabis-based oral spray (nabiximols) can be given safely and practically alongside standard radiation and chemotherapy in adults with newly diagnosed glioblastoma. The main questions it aims to answer are:
How many participants have serious side effects (regimen-limiting toxicities) from the combined treatment? Can participants receive and complete the planned treatment, and how often does the catheter procedure succeed?
Read more
Participants will:
Receive standard care: radiation with the chemotherapy drug temozolomide Take a nabiximols (Sativex) mouth spray daily for 12 months, starting at 2 sprays a day and slowly increasing to the highest dose they tolerate (up to 12 sprays a day) Have three treatment sessions in which a thin catheter is guided through an artery to the tumour's blood vessels to deliver mannitol, which briefly opens the brain's protective barrier, followed by bevacizumab.
- Conditions
- GBM
- Being tested
- Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabCombination product
Also called Mannitol, Temozolomide, Nabiximol
Participants receive standard radiation and temozolomide chemotherapy together with a daily cannabis-based mouth spray (nabiximols, titrated up to 12 sprays a day for 12 months) and three catheter-guided infusions of bevacizumab (15 mg/kg) directly into the tumour's arteries, each given after mannitol briefly opens the blood-brain barrier, at least 45 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Combination Product: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regimen-Limiting Toxicity
Number and proportion of participants with at least one regimen-limiting toxicity, defined as any of the following events assessed as at least possibly related to bevacizumab, mannitol, nabiximols, the intra-arterial procedure or an interaction between them:
Grade ≥3 procedural complication (e.g., arterial dissection, stroke, access-site complication requiring intervention).
Grade ≥3 hemorrhage, or any new or enlarging intracranial hemorrhage. Grade ≥4 non-hematological toxicity. Severe Grade 4 hematological toxicity. Toxicity requiring permanent discontinuation of a study intervention. Treatment-related death.
Measured: From the first nabiximols dose until 6 months after the last nabiximols dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909811
- Sponsor's protocol ID
- NOVA-GBM-PH1-001
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel endOvascular Therapy With beVAcizumab and Cannabinoids for Glioblastoma
- ClinicalTrials.gov ID
- NCT07909811
- Acronym / sponsor ID
- NOVA-GBM-PH1-001
- Conditions
- GBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
The goal of this clinical trial is to learn if a combined treatment of bevacizumab delivered directly to the brain tumour and a cannabis-based oral spray (nabiximols) can be given safely and practically alongside standard radiation and chemotherapy in adults with newly diagnosed glioblastoma. The main questions it aims to answer are:
How many participants have serious side effects (regimen-limiting toxicities) from the combined treatment? Can participants receive and complete the planned treatment, and how often does the catheter procedure succeed?
Participants will:
Receive standard care: radiation with the chemotherapy drug temozolomide Take a nabiximols (Sativex) mouth spray daily for 12 months, starting at 2 sprays a day and slowly increasing to the highest dose they tolerate (up to 12 sprays a day) Have three treatment sessions in which a thin catheter is guided through an artery to the tumour's blood vessels to deliver mannitol, which briefly opens the brain's protective barrier, followed by bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Competent and able to give informed consent Aged 18 years or older Histopathological confirmation of glioblastoma (WHO 2021) via biopsy or maximal safe resection KPS ≥70 Estimated life expectancy of at least 3 months Agreement to use effective contraception Adequate baseline laboratory values
Key exclusion criteria (4 listed)
- Previous treatment with bevacizumab; pregnancy or lactation Serious cardiovascular disease, clinically significant heart failure, or uncontrolled hypertension (≥150/100 mmHg despite therapy) Intracranial hemorrhage (history, Grade ≥2 on baseline MRI, or active bleeding); bleeding diathesis; anticoagulation or dual antiplatelet therapy that cannot be safely interrupted Arterial thromboembolic event within 6 months; venous thromboembolism within 3 months Major surgery or significant trauma within 28 days (the qualifying biopsy or resection is exempt), or an unhealed wound Gastrointestinal perforation, fistula or abscess within 6 months; nephrotic syndrome; significant renal impairment Arterial pathology precluding safe super-selective catheterization Hypersensitivity to bevacizumab, nabiximols, mannitol or (unmanageable) iodinated contrast Personal or first-degree family history of schizophrenia or other psychotic disorder Potent CYP3A4 or CYP2C9 inhibitors or inducers; nephrotoxic or neurotoxic agents that cannot be withheld Well-established anuria due to severe renal disease, or requirement for renal replacement therapy.
- Severe dehydration or hypovolemia that has not been corrected prior to the procedure.
- Pre-existing plasma hyperosmolarity, defined as serum osmolality > 320 mOsm/kg. Clinically significant, uncorrected electrolyte or acid-base disturbance, including serum sodium outside 130-150 mmol/L or serum potassium outside 3.0-5.5 mmol/L.
- Any other significant intercurrent medical or psychiatric condition that, in the judgement of the investigator, would place the patient at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
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 |
|---|---|---|
| BevacizumabAlso: Mannitol, Temozolomide, NabiximolParticipants receive standard radiation and temozolomide chemotherapy together with a daily cannabis-based mouth spray (nabiximols, titrated up to 12 sprays a day for 12 months) and three catheter-guided infusions of bevacizumab (15 mg/kg) directly into the tumour's arteries, each given after mannitol briefly opens the blood-brain barrier, at least 45 days apart. | Combination product | Intervention |
Primary outcome
Regimen-Limiting Toxicity
Time frame: From the first nabiximols dose until 6 months after the last nabiximols dose
Number and proportion of participants with at least one regimen-limiting toxicity, defined as any of the following events assessed as at least possibly related to bevacizumab, mannitol, nabiximols, the intra-arterial procedure or an interaction between them: Grade ≥3 procedural complication (e.g., arterial dissection, stroke, access-site complication requiring intervention). Grade ≥3 hemorrhage, or any new or enlarging intracranial hemorrhage. Grade ≥4 non-hematological toxicity. Severe Grade 4 hematological toxicity. Toxicity requiring permanent discontinuation of a study intervention. Treatment-related death.
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 2 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab in people with GBM, run by Unity Health Toronto.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Eileen Liu (416-360-4000 ext. 40080, Eileen.Liu@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regimen-Limiting Toxicity (time frame: From the first nabiximols dose until 6 months after the last nabiximols dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.