Trials / Enrolling By Invitation
Enrolling By InvitationNCT06896110
Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma
Phase 1 Trial of Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma
- Status
- Enrolling By Invitation
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- Andrew P. Groves · Academic / Other
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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)
Conditions
- Glioblastoma (GBM)
- Diffuse Midline Glioma (DMG)
- Astrocytoma, IDH-Mutant, Grade 4
- Diffuse Hemispheric Glioma, H3 G34-Mutant
- Gliosarcoma of Brain
Interventions
| Type | Name | Description |
|---|---|---|
| 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…) |
Timeline
- Start date
- 2025-06-05
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2025-03-26
- Last updated
- 2025-06-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06896110. Inclusion in this directory is not an endorsement.