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Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial

Open-label Phase II Clinical Trial to Test the Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma

NCT07263438•Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed glioblastoma, according to World Health Organization \[WHO\] 2021 with unequivocal first progression after standard (6 weeks radiotherapy \[RT\]) with concurrent \& adjuvant temozolomide \[TMZ\] chemotherapy.
•Patients must be at least 3 months off the concomitant part of chemo-radiotherapy.
•Stable or decreasing dose of steroids for 7 days prior to the baseline
•Magnetic Resonance Imaging \[MRI\] scan.
•Maximum dose of dexamethasone (or equivalent) 4 mg at time of inclusion.
•No surgery or other invasive procedures (major surgical procedure, open biopsy or significant traumatic injury) within 4 weeks prior to registration.
•No core biopsy or other minor surgical procedure within 7 days prior to registration. (Placement of a central vascular access device, if performed at least 2 days prior to trial treatment administration, is allowed).
•Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs \[non-EIAED\]. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to registration.
•Measurable disease per Response Assessment in Neuro-Oncology \[RANO\] version 2.0 criteria. Recurrent disease must be at least one bi-dimensionally measurable contrast-enhancing lesion with clearly defined margins by MRI scan, with minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm apart, based on MRI scan done within 28 days prior to registration.
•Karnofsky performance status 70-100.
+24 more criteria

Exclusion Criteria

•Patient must be in first progression/recurrence and have not received more than one line of chemotherapy (concurrent and adjuvant temozolomide). Treatment of Time to Treatment Failure \[TTF\] fields (Optune®) is allowed during first line but will be stopped at registration.
•Patients must not have prostate enlargement with urinary retention or angle-closure glaucoma at registration.
•Any other experimental drug must be discontinued at least 30 days prior to registration
•Patients under ongoing treatment with an antidepressant must be eligible for a switch to trimipramine. Patients currently under TriCyclic Antidepressant \[TCAs\] (amitriptyline, clomipramine, nortriptyline, imipramine), selective serotonin reuptake inhibitors (sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) or serotonin and norepinephrine reuptake inhibitors (venlafaxine, duloxetine) must be weaned off these medications for at least 14 days before the introduction of trimipramine.
•Note: Patients treated with fluoxetine prior to enrollment will only be eligible for this trial after a two-month washout period before starting the study treatment.
•Prior treatment with atezolizumab or any other immune checkpoint inhibitors.
•Prior treatment with bevacizumab or other Vascular Endothelial Growth Factor \[VEGF\] inhibitors or VEGF-receptor signaling inhibitors.
•Concomitant or prior use of immunosuppressive medication within 5 half-lives before registration, with the exceptions of intranasal and inhaled corticosteroids.
•Life expectancy of less than 12 weeks.

Locations (7)

Universitätsspital Basel

Basel, Basel, Switzerland

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Bern Inselspital

Bern, Canton of Bern, Switzerland

HFR Fribourg - Hôpital cantonal

Fribourg, Canton of Fribourg, Switzerland

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Universitätsspital Zürich

Zurich, Canton of Zurich, Switzerland

Key Dates

Start Date

November 3, 2025

Primary Completion Date

March 30, 2028

Completion Date

December 31, 2030

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

GlioblastomaRecurrence Tumor

Interventions

Trimipramine

DRUG

Cohort 1: Atezolizumab

BIOLOGICAL

Bevacizumab

BIOLOGICAL

Cohort 2: Atezolizumab

BIOLOGICAL

Cohort 2: Bevacizumab

BIOLOGICAL

Contacts

Andreas Hottinger, MD, PhD

CONTACT

0041 79 556 52 71 andreas.hottinger@chuv.ch

Stéphanie Viguet-Carrin, PhD

CONTACT

0041 79 556 45 63 stephanie.viguet-carrin@chuv.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

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