NEW PHASE 3 CLINICAL TRIAL FOR GLIOBLASTOMA: OPTUNE®, TEMOZOLOMIDE, AND PEMBROLIZUMAB

Continuing with the idea of ​​reporting to you some interesting clinical studies in the recruitment phase as we did in the case of the study on nirapatib, we inform you that there is a new international, randomized, double-blind Phase 3 clinical trial has been initiated in adult patients with newly diagnosed glioblastoma. The study, called EF-41 / KEYNOTE D58, evaluates the efficacy and safety of the combination of Optune® (therapeutic electrical fields – TTF), maintenance temozolomide, and pembrolizumab, compared to standard treatment with Optune® and temozolomide plus placebo. This is a particularly significant study because it integrates, for the first time in a late-stage trial, an immunotherapy (anti-PD-1) into the standard treatment regimen for glioblastoma.

The EF-41 / KEYNOTE D58 study aims to test whether the addition of pembrolizumab, an immunotherapy drug already used in several solid tumors, can improve overall survival and progression-free survival in patients with newly diagnosed glioblastoma, compared to the currently used regimen. Pembrolizumab works by stimulating the patient’s immune system to recognize and attack tumor cells, while Optune® uses low-intensity, high-frequency electric fields (200 kHz) to interfere with tumor cell division.

The study is a Phase 3, randomized, double-blind, placebo-controlled study. Patients are randomly assigned to one of two treatment arms:

• Optune® + maintenance temozolomide + pembrolizumab
• Optune® + maintenance temozolomide + placebo

All patients must have completed initial standard treatment with surgery and radiotherapy. Unlike other recently launched clinical trials, patients may have received radiochemotherapy at centers other than those conducting the study. However, it is essential that enrollment assessments occur immediately after completion of radiotherapy, to comply with the timelines set forth in the trial protocol. Therefore, it is important for interested patients to act quickly and speak with their neuro-oncologist.

In addition to the Humanitas Clinical Institute (Principal Investigator: Prof. Matteo Simonelli), the following centers are currently active in Italy:

• Fondazione IRCCS Istituto Neurologico Carlo Besta – Contact: Antonio Silvani
• Ospedale del Mare – Contact: Bruno Daniele

The list of centers may be expanded in the coming months. The full text of the study, with all inclusion and exclusion criteria, is available on the international clinical trials database at the following link: https://www.clinicaltrials.gov/study/NCT06556563. As always, we remind you that participation in a clinical trial must be evaluated together with your medical team, carefully considering potential benefits, risks, and individual patient characteristics.