NEO100 and High-Grade Meningioma

Inclusion criteria

• ✓. Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed.
• ✓. Residual disease is defined as residual measurable disease (without a requirement for progression). Residual measurable disease is defined by bidimensionally measurable lesions with clearly defined margins by MRI scan(s) with a minimum diameter of 10mm in both dimensions.
• ✓. Progressive disease is defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area). The change must occur between scans separated by no more than 24 months.
• ✓. Recurrent disease is defined as new evidence of measurable disease following complete resection (10mm in both dimensions).
• ✓. Be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.
• ✓. Participants must have failed maximal safe resection and radiation therapy.
• ✓. There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents, however, these treatment(s) must comply with the following:
• ✓. There is no limit on the number of prior therapies.