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

NCT06896110 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Glioblastoma (GBM)
  • Diffuse Midline Glioma (DMG)
  • Astrocytoma, IDH-Mutant, Grade 4
  • Diffuse Hemispheric Glioma, H3 G34-Mutant
  • Gliosarcoma 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…)

Sponsors & Collaborators

  • Andrew P. Groves

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896110 on ClinicalTrials.gov