NEW CLINICAL TRIAL FOR PATIENTS WITH GLIOBLASTOMA: NIRAPARIB IN COMBINATION WITH RADIOTHERAPY

With this article, we would like to address your numerous requests and begin reporting on particularly interesting new clinical trials. We know how important it is to participate in clinical trials and how difficult it is to learn about them and actually participate. We received this tip from a researcher at Humanitas in Milan. We would therefore like to begin acting as a bridge between patients and researchers to promptly report these opportunities.
An international, open-label, randomized, Phase 3 clinical trial is underway in Italy. It will evaluate the efficacy of niraparib (a PARP inhibitor) in combination with radiotherapy (RT), compared to the current standard of radiotherapy plus temozolomide, in patients with newly diagnosed glioblastoma with an unmethylated MGMT promoter.
The study, called GlioFocus, represents an important development because it focuses on a category of patients—those with unmethylated MGMT—for whom temozolomide has shown limited efficacy.

In Italy, the study will be active at:

• Humanitas Clinical Institute IRCCS – Rozzano (Milan), under the direction of Prof. Matteo Simonelli
• IRCCS Institute of Neurological Sciences of Bologna (Dr. Franceschi)
• AOU Careggi of Florence (Dr. Livi)
• IRCCS Carlo Besta of Milan (Dr. Silvani)
• Istituto Oncologico Veneto IOV of Padua (Dr. Lombardi)

Patients who meet the following requirements are eligible for the study:

• Histological diagnosis of newly diagnosed intracranial glioblastoma, according to WHO 2021 guidelines
• Age ≥18 years
• Presence of sufficient tissue for molecular analysis and central pathology review
• Unmethylated MGMT status, determined locally with validated tests
• Eligibility to receive standard radiotherapy (60 Gy in 30 fractions) according to ESTRO-EANO guidelines
• No previous treatment for GBM, except surgery or biopsy.

For further details on the study protocol, please visit the official GlioFocus Clinical Study website and the dedicated page on the GlioFocus Clinical Study database. Clinical trials Clinicaltrials.gov.

This clinical trial represents a significant opportunity for patients with unmethylated MGMT glioblastoma, a condition for which treatment options are still limited. Participation in studies of this type not only provides access to new, potentially more effective therapies, but also contributes to the advancement of glioblastoma research.