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Background <p>Regorafenib is an oral multi-tyrosine kinase (RTK) inhibitor. It exhibits high selectivity for VEGFR1/2/3, while also inhibiting PDGFRβ, FGFR1, and oncogenic signaling cascades involving c-RAF/RAF1 and BRAF. These pathways are highly expressed in meningiomas, particularly in high-grade meningiomas.</p> Methods <p>The MIRAGE trial (NCT06275919) is a multicenter, open-label, controlled, randomized phase 2 clinical trial evaluating grade 2/3 meningioma patients who have progressed following surgery and radiotherapy. A total of 94 participants are being randomized (1:1) to receive either regorafenib (160 mg orally for 3 weeks on, 1 week off) or local standard-of-care therapies (e.g., bevacizumab, hydroxyurea, somatostatin analogs). Major inclusion criteria include histological confirmation of grade 2 or grade 3 meningioma according to the WHO 2021 classification, radiologically documented progression according to RANO criteria with at least 1 measurable lesion (minimum 10 × 10 mm) on baseline MRI, ineligibility for further surgery and/or radiotherapy, and a WHO performance status of 0–1. The primary endpoint is 6-month progression-free survival (6m-PFS) and secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and health-related quality of life. Exploratory analysis will also be performed. MIRAGE, initiated in September 2024, is an academic trial promoted by the Istituto Oncologico Veneto, IOV-IRCCS, and will recruit patients across 15 neuro-oncology centers in Italy with an estimated study duration of 18 months.</p> Discussion <p>MIRAGE is a phase 2 trial designed to determine the role of regorafenib in prolonging the PFS of grade 2–3 meningioma patients ineligible for further surgery and/or radiotherapy.</p> Trial registration <p>ClinicalTrials.gov NCT06275919. Registered before start of inclusion, 7 February 2024. EuCT no. 2024–510954-28.</p>

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Regorafenib versus local standard of care in patients with grade 2–3 meningioma no longer eligible for loco-regional treatments: a phase II randomized controlled trial (the MIRAGE study)

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  • 发表日期：

    2025年8月4日

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  • Alberto Bosio,
  • Giulia Cerretti,
  • Marta Padovan,
  • Paola Del Bianco,
  • Maurizio Polano,
  • Susanna Mandruzzato,
  • Stefano Indraccolo,
  • Renzo Manara,
  • Giovanni Librizzi,
  • Mario Caccese,
  • Martina Corrà,
  • Marta Maccari,
  • Sara Lonardi,
  • Gian Luca De Salvo,
  • Giuseppe Lombardi

摘要

Background

Regorafenib is an oral multi-tyrosine kinase (RTK) inhibitor. It exhibits high selectivity for VEGFR1/2/3, while also inhibiting PDGFRβ, FGFR1, and oncogenic signaling cascades involving c-RAF/RAF1 and BRAF. These pathways are highly expressed in meningiomas, particularly in high-grade meningiomas.

Methods

The MIRAGE trial (NCT06275919) is a multicenter, open-label, controlled, randomized phase 2 clinical trial evaluating grade 2/3 meningioma patients who have progressed following surgery and radiotherapy. A total of 94 participants are being randomized (1:1) to receive either regorafenib (160 mg orally for 3 weeks on, 1 week off) or local standard-of-care therapies (e.g., bevacizumab, hydroxyurea, somatostatin analogs). Major inclusion criteria include histological confirmation of grade 2 or grade 3 meningioma according to the WHO 2021 classification, radiologically documented progression according to RANO criteria with at least 1 measurable lesion (minimum 10 × 10 mm) on baseline MRI, ineligibility for further surgery and/or radiotherapy, and a WHO performance status of 0–1. The primary endpoint is 6-month progression-free survival (6m-PFS) and secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and health-related quality of life. Exploratory analysis will also be performed. MIRAGE, initiated in September 2024, is an academic trial promoted by the Istituto Oncologico Veneto, IOV-IRCCS, and will recruit patients across 15 neuro-oncology centers in Italy with an estimated study duration of 18 months.

Discussion

MIRAGE is a phase 2 trial designed to determine the role of regorafenib in prolonging the PFS of grade 2–3 meningioma patients ineligible for further surgery and/or radiotherapy.

Trial registration

ClinicalTrials.gov NCT06275919. Registered before start of inclusion, 7 February 2024. EuCT no. 2024–510954-28.