Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
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
Timeline
- Start
- 2020-06-20
- Primary completion
- 2029-12-01
- Completion
- 2030-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Brigatinib | Small molecule | 180 mg | Oral |
| Subject | Neratinib | Small molecule | 200 mg | Oral |
| Subject | Neratinib | Small molecule | 240 mg | Oral |
| Subject | Retifanlimab | Monoclonal antibody | 375 mg | Intravenous |