Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04374305 | Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) | PHASE2 | RECRUITING | 109 | — | — | Jun 20, 2020 | Dec 1, 2030 | May 6, 2026 | 6 | United States |
Radiographic response rates in target tumors according to tumor-associated criteria: * VS, non-VS, and meningiomas: Dombi criteria (2013) * Ependymomas: RECIST 1.12
| Arm | Type | Description |
|---|---|---|
| Sub-study A (brigatinib) - CLOSED TO ENROLLMENT | EXPERIMENTAL | Subjects treated in this arm will receive brigatinib 90 mg by mouth daily for 7 days and then increased to 180 mg by mouth daily if the drug is tolerated. |
| Sub-study B (neratinib) | EXPERIMENTAL | The first three participants treated in this arm will receive neratinib 200 mg mg by mouth daily. If these participants tolerate the medication well, subsequent participants will receive neratinib 240 mg by mouth daily. |
| Experimental: sub-study C (retifanlimab plus bevacizumab) | EXPERIMENTAL | Subjects on this arm will receive retifanlimab by IV infusion at a dose of 375 mg every 3 weeks on a continuous schedule for 48 weeks. Subjects will also receive bevacizumab by IV infusion at a dose of 7.5 mg/kg every 3 weeks on an intermittent schedule. One cycle last 42 days and the study will last for 52 total weeks (48 treatment weeks and 4 follow-up weeks). |
| Name | Type | Description |
|---|---|---|
| Brigatinib | DRUG | Oral daily per predetermined dosage per protocol. |
| Neratinib | DRUG | Oral daily per predetermined dosage per protocol. |
| Retifanlimab | DRUG | Every 3 weeks by IV per predetermined dose in protocol. |
| Bevacizumab | DRUG | Every 3 weeks by IV per predetermined dose in protocol. |
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 ...