Table 4.
Selected Ongoing Clinical Trials on Systemic Therapies in Meningiomas
| Principal investigator | Estimated completion | Study design | Study population and key eligibility criteria | Systemic/experimental agent | Primary endpoint | NCT # |
|---|---|---|---|---|---|---|
| Jiayi Huang | 2023 | Neoadjuvant avelumab and hypofractionated proton radiation therapy followed by surgery for recurrent radiation-refractory meningioma | WHO grade 1–3 meningioma which has failed maximal safe resection + radiation therapy | Avelumab (10 mg/kg IV q2weeks for 3 months), proton therapy (20 CGE/5 daily fractions of 4 CGE per day) | CD8+/CD4 + tumor-infiltrating lymphocytes | NCT03267836 |
| David A. Reardon | 2024 | An open-label phase II study of nivolumab and ipilimumab in adult participants with progressive/recurrent meningioma | Progressive or recurrent meningiomas with KPS ≥ 70 | Nivolumab (240 mg q2 weeks), Ipilimumab 1 mg/kg q3weeks) | PFS-6 | NCT02648997 |
| Priya Kumthekar | 2024 | Optune delivered electric field therapy and bevacizumab in treating patients with recurrent or progressive grade 2 or 3 meningioma | Progressive or recurrent meningiomas KPS ≥ 60 | Bevacizumab IV dose not specified, electric field therapy using Optune daily over 18 hours | PFS-6 | NCT02847559 |
| Priscilla K. Brastianos | 2024 | Vismodegib, capivasertib, and abemaciclib in treating patients with progressive meningiomas | Progressive or recurrent meningiomas | Vismodegib (PO once daily), capivasertib (PO BID days 1–4, treatment q7days), abemaciclib (PO q12h), FAK inhibitor GSK2256098 (PO BID) | PFS-6 | NCT02523014 |
| Erik P. Sulman | 2025 | A phase II trial of 177Lu-DOTATATE for recurrent/progressive meningioma | Progressive meningioma (any grade) with KPS ≥ 60 | 177Lu-DOTATATE intravenously every 8 weeks up to 4 cycles | PFS-6 | NCT03971461 |
| Recursion Pharmaceuticals | 2027 | Efficacy and safety of REC-2282 in patients with progressive neurofibromatosis type 2 (NF2) mutated meningiomas (POPLAR-NF2) | Progressive and recurrent NF2 meningiomas | Small molecule HDAC inhibitor REC 2282 (30–60 mg PO 3 times per week, for 3 of the 4 weeks) | PFS-6 | NCT05130866 |
| Marta Penas-Prado | 2027 | Phase II trial of the immune checkpoint inhibitor nivolumab in patients with recurrent select rare CNS cancers | Atypical or malignant meningioma | Nivolumab (240 mg IV q2weeks for cycles 1–2, then 480 mg q4weeks for 14 additional doses) | PFS-6, CR/PR | NCT03173950 |
| Rupesh R. Kotecha | 2028 | A phase II study of cabozantinib for patients with recurrent or progressive meningioma | Progressive or recurrent meningiomas with KPS ≥ 50 | Cabozantinib (60 mg PO daily for 28 days) | PFS-6 | NCT05425004 |
| Nancy Ann Oberheim Bush | 2028 | Stereotactic radiosurgery (SRS) and immunotherapy (Pembrolizumab) for the treatment of recurrent meningioma | Recurrent WHO grade 2 or 3 meningioma | SRS (15–20 Gy/1 Fr or 25–30 Gy/5 Fr) combined with pembrolizumab (200 mg IV on day 1 to −1 of radiation then q3weeks) | PFS-12 | NCT04659811 |
WHO, World Health Organization; NCT, National Clinical Trial; CGE, Cobalt Gray Equivalent; KPS, Karnofsky Performance Score; PFS-6/12, Progression-free survival at 6/12 months; CR, complete response; PR, partial response; CNS, central nervous system; PO, per os; BID, twice per day.