Actively Recruiting
Regorafenib for Recurrent Meningioma (MIRAGE Trial)
Led by Istituto Oncologico Veneto IRCCS · Updated on 2026-05-13
104
Participants Needed
17
Research Sites
127 weeks
Total Duration
On this page
Sponsors
I
Istituto Oncologico Veneto IRCCS
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Regorafenib for Recurrent Meningioma (MIRAGE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must understand and voluntarily sign informed consent
- Patients must be able to take oral medication
- Willing and able to follow study visit schedule and protocol requirements
- Histological diagnosis of meningioma per WHO 2021 classification
- Radiologically documented tumor progression >25% in last 12 months or new lesions
- Not eligible for further surgery or radiotherapy
- At least one measurable lesion (minimum 10 x 10 mm) on baseline MRI
- ECOG performance status of 0 to 1 or Karnofsky score ≥70
- Male or female aged 18 years or older
- Life expectancy of at least 6 months
- Available paraffin-embedded tumor tissue sample
- Dexamethasone or equivalent steroid dose ≤4 mg/day within 7 days before randomization
- Stable or decreasing steroid dose for 7 days before randomization
- Adequate heart, liver, kidney, and blood function per specified lab values
- Women of childbearing potential must agree to contraception during treatment and 6 months after
- Male partners of premenopausal women must agree to use barrier contraception during treatment and 6 months after
- Patients with certain controlled conditions like type I diabetes, hypothyroidism on hormones, or stable skin disorders
- Patients with prior radiation therapy must show progression at least 24 weeks after completion
- Possible prior bevacizumab use for radionecrosis within specified timeframe
You will not qualify if you...
- Prior antineoplastic therapy for meningioma
- Unable to understand or voluntarily sign informed consent
- Taking strong CYP3A4 inhibitors or inducers
- Taking strong UGT1A9 inhibitors
- Receiving other active treatment for meningioma outside the trial
- Disease outside the brain such as spinal cord or distant metastasis
- Candidate for urgent palliative intervention for primary disease
- Allergy or hypersensitivity to study treatments or excipients
- Abnormal coagulation tests beyond therapeutic limits if anticoagulated
- Unable or unwilling to have brain MRI with intravenous gadolinium
- History of another malignancy within past 3 years except certain skin cancers or in situ cancers
- Serious non-healing wounds, ulcers, fractures, or abscesses
- Cerebrovascular accident within 6 months before starting treatment
- Ongoing infection of Grade 2 severity or higher
- Significant recent hemorrhage or thrombotic events
- Uncontrolled or severe cardiac disease or arrhythmias
- History of interstitial lung disease or related lung conditions
- Active or suspected autoimmune disease
- Known active hepatitis B, C requiring treatment, or HIV infection
- History of bleeding disorders
- Uncontrolled illnesses or infections
- Persistent elevated lipase or proteinuria beyond specified limits
- Malabsorption conditions
- Any condition impairing compliance with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, Forlì-Cesena, Italy
Actively Recruiting
2
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, Italia/Messina, Italy, 98124
Actively Recruiting
3
Humanitas Cancer Center
Rozzano, Milano, Italy
Actively Recruiting
4
A.O.U. Policlinico di Bari
Bari, Italy
Actively Recruiting
5
Ospedale San Paolo
Bari, Italy
Completed
6
Ospedale Bellaria - AUSL Bologna
Bologna, Italy
Actively Recruiting
7
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
8
Policlinico San Martino
Genova, Italy
Actively Recruiting
9
Spedali Riuniti
Livorno, Italy
Actively Recruiting
10
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
11
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
12
Ospedale del Mare
Naples, Italy
Actively Recruiting
13
Istituto Oncologico Veneto
Padova, Italy, 35128
Actively Recruiting
14
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
15
IRCCS Istituto Tumori Regina Elena
Roma, Italy
Actively Recruiting
16
Policlinico Umberto I - Università Sapienza Roma
Roma, Italy
Not Yet Recruiting
17
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
Actively Recruiting
Research Team
G
Gian Luca De Salvo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here