Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Scott R. Plotkin, MD, PhD
Summary
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
Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drug(s) works in treating a specific disease. As a basket study, the trial will enroll patients with NF2-SWN with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas The MASTER STUDY is intended to enroll participants who will be allocated into different treatment arms (SUB-STUDIES) which will each have an additional consent and enrollment processes. MASTER STUDY…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Specific For MASTER PROTOCOL: Inclusion Criteria: \- Patients must have a pathogenic variant in the NF2 gene (either in the germline or in two NF2-related tumors) OR a confirmed diagnosis of NF2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria: The NIH criteria includes presence of: * Bilateral vestibular schwannomas, OR * First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity. The Manchester criteria includes…
Interventions
- DrugBrigatinib
Oral daily per predetermined dosage per protocol.
- DrugNeratinib
Oral daily per predetermined dosage per protocol.
- DrugRetifanlimab
Every 3 weeks by IV per predetermined dose in protocol.
- DrugBevacizumab
Every 3 weeks by IV per predetermined dose in protocol.
Locations (6)
- UCLA Medical CenterLos Angeles, California
- University of MiamiMiami, Florida
- Indiana University School of MedicineIndianopolis, Indiana
- Johns Hopkins HospitalBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- New York University Langone Medical CenterNew York, New York