OncoMatch/Clinical Trials/NCT06275919
Regorafenib for Recurrent Meningioma (MIRAGE Trial)
Is NCT06275919 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Regorafenib 40 MG Oral Tablet and Local Standard of Care for meningioma, malignant.
Treatment: Regorafenib 40 MG Oral Tablet · Local Standard of Care — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antineoplastic therapy
Exception: Possible prior use of bevacizumab in the treatment of radionecrosis (3-24 months after radiosurgery or radiotherapy; 5mg/kg q14w, 4-6 cycles)
Prior antineoplastic therapy for meningioma
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L without growth factor support for 7 days (14 days if subject received pegfilgrastim); Hemoglobin ≥10 g/dL; Platelet count ≥100 x 10^9/L
Kidney function
Serum creatinine ≤ 1.5 x ULN or measured GFR ≥ 50 mL/min/1.73 m2 or creatinine clearance of ≥ 50 mL/min
Liver function
SGOT/AST and SGPT/ALT ≤ 3.0 x ULN; Serum total bilirubin ≤ 1.5 x ULN
Cardiac function
Adequate cardiac function; exclusion for uncontrolled or severe cardiac disease
Adequate cardiac function and adequate liver, renal and hematological function; see laboratory values at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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