drugset / Trial / NCT06896110

Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma

NCT06896110

Phase 1 Enrolling by invitation 34 enrolled Andrew P. Groves
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm open-label phase 1 dose escalation/expansion trial assessing the safety and efficacy of concurrent intrathecal azacitidine and intrathecal nivolumab in recurrent high-grade glioma.

Timeline

Start
2025-06-05
Primary completion
2027-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 5 mg Intrathecal
Subject Azacitidine Other / unclassified 10 mg Intrathecal
Subject Azacitidine Other / unclassified 20 mg Intrathecal
Subject Azacitidine Other / unclassified 40 mg Intrathecal
Subject Nivolumab Monoclonal antibody 40 mg Intrathecal