Entacapone Plus Bevacizumab for Glioblastoma at First Recurrence

Summary

This investigator-initiated, multicenter clinical trial will evaluate the safety and preliminary effectiveness of adding entacapone to bevacizumab in adults with isocitrate dehydrogenase (IDH)-wildtype glioblastoma at first recurrence after standard first-line treatment. Participants must not have previously received bevacizumab. A multidisciplinary neuro-oncology team must determine that repeat tumor resection is not appropriate, or the patient must decline repeat surgery after being informed of its potential benefits and risks. The study has two stages. In the first stage, 6 participants who can be evaluated for dose-limiting toxicity will receive open-label entacapone 400 mg by mouth three times daily plus bevacizumab. Enrollment will occur in two cohorts of 3, with safety review by an independent data and safety monitoring board. Up to 3 participants who cannot complete the 28-day toxicity evaluation for reasons unrelated to toxicity may be replaced. If the combination has acceptable safety and the required approvals are obtained, 90 new participants will enter the second stage and be randomly assigned in a 1:1 ratio to entacapone or matching placebo. Both groups will receive bevacizumab. The primary endpoint of the randomized stage is progression-free survival assessed by blinded independent central review. The study plans to obtain data from 96 evaluable participants, with no more than 99 participants receiving study treatment.

Timeline

Start

2026-10-01

Primary completion

2029-09-30

Completion

2029-09-30

Drugs

Indications