Actively Recruiting
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Led by Scott R. Plotkin, MD, PhD · Updated on 2026-05-06
109
Participants Needed
6
Research Sites
545 weeks
Total Duration
On this page
Sponsors
S
Scott R. Plotkin, MD, PhD
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-arm phase II platform-basket screening study designed to test multiple experimental therapies simultaneously in patients with NF2-related schwannomatosis (NF2-SWN, formerly known as neurofibromatosis type 2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2-SWN to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. * Investigational Drug Sub-study A: Brigatinib * Investigational Drug Sub-study B: Neratinib * Investigational Drug Sub-study C: Retifanlimab plus bevacizumab
CONDITIONS
Official Title
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a pathogenic NF2 gene variant or meet NIH or Manchester criteria for NF2 diagnosis
- Must have progressive NF2-related tumors (vestibular schwannomas, non-vestibular schwannomas, meningiomas, or ependymomas) with documented growth within the last 36 months
- Tumors must be measurable by MRI or linear measurement criteria
- Tumors not suitable for surgery due to patient choice or high surgical risk
- Age 12 years or older at treatment start
- Life expectancy greater than 1 year
- Karnofsky performance status of 70 or higher or ECOG performance status 0 or 1
- Ability to understand and sign informed consent and assent
- Established relationship with a primary care physician
You will not qualify if you...
- Chemotherapy within 4 weeks or radiation to the target tumor within 3 years before study registration
- Receiving other investigational agents
- Nervous system tumors likely requiring active treatment including surgery within 6 months
- History of other malignancies unless disease-free for at least 2 years and low risk for recurrence
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women
- Sub-study specific exclusions include recent investigational treatment, major surgery within 30 days, significant cardiovascular disease, known HIV infection, gastrointestinal malabsorption, allergic reactions to study drugs, and other conditions as detailed in protocol
AI-Screening
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Trial Site Locations
Total: 6 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Indiana University School of Medicine
Indianopolis, Indiana, United States, 46202
Not Yet Recruiting
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
New York University Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
Research Team
S
Scott Plotkin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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