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

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

June 5, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Glioblastoma (GBM)Diffuse Midline Glioma (DMG)Astrocytoma, IDH-Mutant, Grade 4Diffuse Hemispheric Glioma, H3 G34-MutantGliosarcoma of Brain
Interventions
DRUG

Nivolumab

Intrathecal nivolumab will be given at a flat dose of 40 mg

DRUG

Azacitidine (AZA)

Intrathecal azacitidine will be dose-escalated with 4 dose levels (5, 10, 20, 40 mg) using a 3+3 design.

PROCEDURE

lumbar puncture

Lumbar puncture for intrathecal delivery and collection of CSF

DIAGNOSTIC_TEST

MRI Contrast

MRI Brain and full Spine (with and without contrast) will be performed prior to enrollment. During trial therapy, MRI Brain (with and without contrast) will be performed after cycle 1 and after that every 8 weeks (e.g. after cycle 3, cycle 5, etc…)

Trial Locations (1)

52242

Holden Comprehensive Cancer Center, Iowa City

All Listed Sponsors
lead

Andrew P. Groves

OTHER

NCT06896110 - Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma | Biotech Hunter | Biotech Hunter