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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Andrew P. Groves
Study ID
NCT06896110
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Intrathecal nivolumab will be given at a flat dose of 40 mg
  • Azacitidine (AZA) — DRUG
    Intrathecal azacitidine will be dose-escalated with 4 dose levels (5, 10, 20, 40 mg) using a 3+3 design.
  • lumbar puncture — PROCEDURE
    Lumbar puncture for intrathecal delivery and collection of CSF
  • MRI Contrast — DIAGNOSTIC_TEST
    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…)

Study Details

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.

Key Dates

Start date
Jun 5, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (IT nivolumab + IT azacitidine)
    Patients will receive intrathecal azacitidine on day 1, 8, and 22 of cycle 1 (34 day cycle). Intrathecal nivolumab will be given at a flat dose of 40 mg on day 8 and 22. Each subsequent cycle will be 28 days with intrathecal azacitidine and intrathecal nivolumab given on days 1 and 15. Intrathecal azacitidine will be dose-escalated with 4 dose levels (5, 10, 20, 40 mg) using a 3+3 design. Patients may continue on study in the absence of disease progression or unacceptable toxicity. Patients will have CSF and blood specimen collection on days 1 and 8 of cycle 1, and then day 1 of every-other cycle starting with cycle 2. Patients will undergo MRI at baseline, then every 8 weeks (e.g. after cycle 3, cycle 5, etc…).

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Holden Comprehensive Cancer CenterIowa CityIowa52242-

Find similar trials in Iowa City, IA

By research site
Holden Comprehensive Cancer Center· Iowa City, IA

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