NCT06275919

Regorafenib for Recurrent Meningioma (MIRAGE Trial)

Regorafenib for Recurrent Meningioma. A Multicenter, Randomized Phase II Study (MIRAGE Trial)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent meningiomas. Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome. Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas. Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice. Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life.

Conditions

• Meningioma, Malignant

Interventions

Type	Name	Description
DRUG	Regorafenib 40 MG Oral Tablet	REGORAFENIB 40 mg tablets once daily (160 mg/die), 3 weeks on, 1 week off, until disease progression or unacceptable toxicity
DRUG	Local Standard of Care	In this setting there are not drugs with indication. Every site will treat patients as per their experience.

Timeline

• Start date: 2024-09-23
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-02-23
• Last updated: 2026-03-27

Locations

17 sites across 1 country: Italy