RecruitingPhase 2

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

United States109 participantsStarted 2020-06-20

Plain-language 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

Who can participate

Age range12 Years

SexALL

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Exclusion criteria

✕. Leukocytes ≥3000/mcL
✕. Platelets ≥100,000/mcL
✕. Total Bilirubin ≤ 1.5 institutional upper limit of normal (ULN), (\<3.0 × institutional ULN for patients with Gilbert Syndrome)
✕. AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
✕. Urine Protein:Creatinine Ratio ≤ 1.9
✕. Glomerular Filtration Rate (GFR) ≥30 mL/min/1.73 m2
✕. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
✕. Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.

What they're measuring

Radiographic response rate (for each drug substudy)

Timeframe: 2 years

Trial details

NCT IDNCT04374305

SponsorScott R. Plotkin, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-01

Contact for this trial

Scott Plotkin, MD

617-643-8992 lmhibyan@mgb.org

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