Phase II Study Testing Targeted Treatments Including Brigatinib, Neratinib, and Retifanlimab Plus Bevacizumab in Patients Aged 12 and Older with NF2-Related Schwannomatosis Tumors

What this Trial Is About

Researchers are conducting a phase II basket trial to study multiple experimental treatments in patients with NF2-related schwannomatosis NF2-SWN who have progressive tumors including vestibular schwannomas, non-vestibular schwannomas, meningiomas, and ependymomas. This trial allows people with various NF2-SWN tumor types to receive new drugs through individual drug substudies within the Master Study framework. The goal is to assess the activity and safety of these therapies over time. The study includes three investigational drug sub-studies Brigatinib, Neratinib, and a combination of Retifanlimab plus Bevacizumab. Each drug has specific dosing schedules Brigatinib is taken orally daily with dose escalation if tolerated Neratinib is taken orally daily with initial lower dosing for tolerability Retifanlimab and Bevacizumab are administered by intravenous infusion every three weeks over a year-long treatment period. Participants may be randomized to one of these treatment arms or remain under observation if ineligible for active treatment arms. The study allows switching between sub-studies if tumors grow during treatment. Participants undergo screening for eligibility, randomization, and treatment or observation for up to 10 years. Researchers will monitor tumor responses using radiographic imaging to measure changes in tumor size as the primary outcome over two years. Safety and tolerability are also tracked by recording adverse events. Additional assessments may include PET scans for a subset of participants in the Neratinib sub-study. Participants will have regular visits for treatment administration, imaging, lab tests, and questionnaires to assess treatment effects and side effects throughout the study duration.

Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)