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

NCT07263438 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-02-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2028-03-30
Completion
2030-12-31

Countries

  • Switzerland

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263438 on ClinicalTrials.gov