NCT06466798

Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma, Ependymoma, and Other CNS Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jeffrey Treiber · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the safety, toxicity, and antitumor activity of fourth ventricular infusions of nivolumab plus 5-azacytidine for recurrent ependymoma and nivolumab plus methotrexate for recurrent medulloblastoma and other CNS malignancies. Additionally, the study will explore immunologic responses to nivolumab. The hypothesis is that local administration of nivolumab, an immune checkpoint inhibitor, is safe and will lead to even more robust treatment responses when administered following 5-azacytidine in patients with recurrent ependymoma or methotrexate in patients with medulloblastoma or other CNS tumors.

Conditions

• Recurrent Ependymoma
• Recurrent Medulloblastoma
• CNS Malignancies

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab infusions will be given intraventricularly once every other week for 12 weeks. Dosing will be based upon patient body weight.
DRUG	Methotrexate	2 mg methotrexate infusions will be given intraventricularly daily for 4 consecutive days per week every other week for 12 weeks.
DRUG	5-Azacytidine	10 mg 5-Azacytidine infusions will be given intraventricularly once weekly for twelve consecutive weeks.

Timeline

• Start date: 2024-07-15
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-06-20
• Last updated: 2026-01-08

Regulatory

• FDA-regulated drug study