A Phase 1 interventional study of Bevacizumab in GBM, sponsored by Unity Health Toronto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Unity Health Toronto · Phase 1, Interventional, and Treatment
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.
Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Competent and able to give Aged 18 years or older Histopathological confirmation of glioblastoma (WHO 2021) via or maximal safe resection ≥70 Estimated of at least 3 months Agreement to use effective Adequate baseline laboratory values
Exclusion Criteria:
Previous treatment with bevacizumab; pregnancy or lactation Serious cardiovascular disease, 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 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 to bevacizumab, nabiximols, mannitol or (unmanageable) iodinated contrast Personal or first-degree family history of schizophrenia or other psychotic disorder Potent 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Bevacizumab
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.
Also known as: Mannitol, Temozolomide, Nabiximol
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.
Time frame: From the first nabiximols dose until 6 months after the last nabiximols dose
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bevacizumab