NCT07263438

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• Recurrence Tumor

Interventions

Type	Name	Description
DRUG	Trimipramine	Trimipramine: daily oral intake at 75mg/ day for 7 days, then at 150 mg/ day
BIOLOGICAL	Cohort 1: Atezolizumab	Atezolizumab: intravenous administration at 1200 mg on the first day of 3-week cycles.
BIOLOGICAL	Bevacizumab	Bevacizumab will be administered intravenously at 15 mg/kg on the first day of 3-week cycles.
BIOLOGICAL	Cohort 2: Atezolizumab	Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on the first day of 3-week cycles. Administration will occur once, then will be interrupted during a recovery period of 14-days post surgery, and then resumed.
BIOLOGICAL	Cohort 2: Bevacizumab	Bevacizumab will be administered intravenously at 15 mg/kg on the first day of 3-week cycles. The first administration will take place 5 weeks after surgery.

Timeline

• Start date: 2025-11-03
• Primary completion: 2028-03-30
• Completion: 2030-12-31
• First posted: 2025-12-04
• Last updated: 2026-02-13

Locations

7 sites across 1 country: Switzerland