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OncoMatch/Clinical Trials/NCT07263438

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

Is NCT07263438 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for glioblastoma.

Phase 2RecruitingCentre Hospitalier Universitaire VaudoisNCT07263438Data as of May 2026

Treatment: Trimipramine · Cohort 1: Atezolizumab · Bevacizumab · Cohort 2: Atezolizumab · Cohort 2: BevacizumabThis 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Performance status

KARNOFSKY 70–100

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: radiation therapy — concurrent with temozolomide

standard (6 weeks radiotherapy [RT]) with concurrent & adjuvant temozolomide [TMZ] chemotherapy

Must have received: alkylating agent (temozolomide) — concurrent and adjuvant

standard (6 weeks radiotherapy [RT]) with concurrent & adjuvant temozolomide [TMZ] chemotherapy

Cannot have received: atezolizumab (atezolizumab)

Prior treatment with atezolizumab or any other immune checkpoint inhibitors

Cannot have received: immune checkpoint inhibitor

Prior treatment with atezolizumab or any other immune checkpoint inhibitors

Cannot have received: VEGF inhibitor (bevacizumab)

Prior treatment with bevacizumab or other Vascular Endothelial Growth Factor [VEGF] inhibitors or VEGF-receptor signaling inhibitors

Cannot have received: VEGF-receptor signaling inhibitor

Prior treatment with bevacizumab or other Vascular Endothelial Growth Factor [VEGF] inhibitors or VEGF-receptor signaling inhibitors

Lab requirements

Blood counts

neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L

Kidney function

eGFR ≥ 45 mL/min/1.73 m2 (CKD-EPI formula)

Liver function

total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome ≤ 3.0 x ULN), AST and ALT and alkaline phosphatase ≤ 2.5 x ULN

Adequate bone marrow function: neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L. Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome ≤ 3.0 x ULN), AST and ALT and alkaline phosphatase ≤ 2.5 x ULN. Adequate renal function: eGFR ≥ 45 mL/min/1.73 m2 (CKD-EPI formula).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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