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NCT06896110

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

StatusEnrolling by Invitation
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Andrew P. Groves

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 2027 to Mar 2028
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 3 words
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of May 2025 to Jun 5, 2025
    • Site contact updated
    v3
  3. Site contact updated
    • Study title shortened, about 4 words
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of adverse events
Timeframe: 24 months
Maximum tolerated dose (MTD) of intrathecal azacitidine in combination with intrathecal nivolumab
Timeframe: 24 months
Overall Response Rate (Expansion Cohort)
Timeframe: 24 months

Secondary (4)

To estiamte the duration of response (DOR)
To estimate progression-free survival
To estimate overall survival
To assess biomarkers for immunologic and epigenetic effects of therapy

Arms and interventions

Treatment (IT nivolumab + IT azacitidine)Experimental

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…).

Drugs: Nivolumab, Azacitidine (AZA)

Procedures: lumbar puncture

Diagnostic tests: MRI Contrast

Sites

1 site in 1 country

  • Holden Comprehensive Cancer CenterIowa City, Iowa, United States