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

Glioblastoma (GBM), Diffuse Hemispheric Glioma, H3 G34-mutant, Astrocytoma, IDH-Mutant, Grade 4, Gliosarcoma of Brain, Diffuse Midline Glioma (DMG)
Iowa
12/25/2025
Other
Participation Deadline: 03/01/2027
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Description

PRIMARY OUTCOME Phase I To determine the safety and maximum tolerated dose (MTD) of intrathecal (IT) azacitidine in combination with IT nivolumab in patients with recurrent high-grade glioma

Expansion Cohort To estimate the overall response rate (ORR)

SECONDARY OUTCOMES

To estimate:

1. Duration of response (DOR)
2. Progression-free survival (PFS)
3. Overall survival (OS)

EXPLORATORY OUTCOMES Changes in immune profiling (flow cytometry, cytokine/chemokine analysis) and circulating tumor DNA (ctDNA) biomarkers (quantification, DNA methylation)

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