Actively Recruiting
Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2026-02-13
59
Participants Needed
7
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicentric phase II open-label clinical trial aiming to assess the efficacy of the combination of trimipramine and atezolizumab with bevacizumab in patients with recurrent glioblastoma. Eligible patients will be assigned to two cohorts depending on whether there is a medical indication for a neurosurgical resection from first recurrent tumor or not. The aim of the cohort 1 (patients without indication for surgery) is to analyze the clinical efficacy of this triple combination in recurrent glioblastoma. 48 patients will be registered. The aim of cohort 2 (patients with indication for surgery) is to confirm the level of trimipramine that can be achieved in the tumor tissue and cerebrospinal fluid collected during surgery. At least 5 patients will be registered. All patients will receive the combination treatment (trimipramine and atezolizumab associated with bevacizumab) for a maximum period of 2 years from registration. The treatment schedule is slightly different for the 2 cohorts because of the neurosurgical resection foreseen for cohort 2 and the requirement to start bevacizumab only after the surgery. After the end of treatment, all patients will be followed up for safety during 90 days from first treatment administration and then up to 3 years from registration.
CONDITIONS
Official Title
Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed glioblastoma with first recurrence after standard radiotherapy and temozolomide chemotherapy
- At least 3 months since completing chemo-radiotherapy
- Stable or decreasing steroid dose for 7 days before baseline
- MRI scan confirming measurable recurrent tumor lesion at least 10 mm in size
- Karnofsky performance status between 70 and 100
- Adequate bone marrow, liver, kidney, and coagulation function as specified
- Maximum dexamethasone dose of 4 mg at inclusion
- No major surgery within 4 weeks or minor surgery within 7 days before registration
- Use of non-enzyme inducing antiepileptic drugs if on anti-convulsant therapy
- Women of childbearing potential must use effective contraception and have a negative pregnancy test
- Men must agree not to father a child during treatment and 6 months after
- Ability and willingness to swallow the trial drug whole
- For cohort 2 only: consent to provide tumor tissue and cerebrospinal fluid collected during surgery and indication for neurosurgical resection
You will not qualify if you...
- More than one prior line of chemotherapy or prior treatment with atezolizumab, bevacizumab, or similar drugs
- Prostate enlargement with urinary retention or angle-closure glaucoma
- Use of any other experimental drug within 30 days before registration
- Current use of certain antidepressants without adequate washout (including fluoxetine with 2-month washout)
- Use of immunosuppressive medication within 5 half-lives before registration, except inhaled or intranasal corticosteroids
- Life expectancy less than 12 weeks
- Active systemic infections or uncontrolled chronic infections such as HIV or hepatitis
- Recent cerebrovascular accident or brain hemorrhage within 6 months
- Severe or uncontrolled cardiovascular disease or arrhythmias
- Corrected QT interval (QTcF) of 450 msec or more, or other risk factors for arrhythmia
- History of autoimmune disease except controlled diabetes type II or hypothyroidism
- Use of monoamine oxidase inhibitors within 14 days before starting trimipramine
- Known allergy to trial drugs or components
- Any other serious medical, psychiatric, or social condition that could interfere with study participation
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Trial Site Locations
Total: 7 locations
1
Universitätsspital Basel
Basel, Basel, Switzerland, 4031
Actively Recruiting
2
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland, 5001
Actively Recruiting
3
Bern Inselspital
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
4
HFR Fribourg - Hôpital cantonal
Fribourg, Canton of Fribourg, Switzerland, 1708
Actively Recruiting
5
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, Switzerland, 6000
Actively Recruiting
6
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
7
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
A
Andreas Hottinger, MD, PhD
CONTACT
S
Stéphanie Viguet-Carrin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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