NCT06896110
Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma
Enrolling by Invitation
PHASE1Ages 13+InterventionalTreatmentAndrew P. GrovesInvestigator-initiated
~34 participants
Updated 2025-06-26 on ClinicalTrials.gov
What's tested:NivolumabAzacitidine (AZA)lumbar punctureMRI Contrast
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over 24 months
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesIowa1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
50 mL/min
50 ml/min 13. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours of starting therapy 14. WOCBP must agree to follow instructions for methods of contraception 15. Men who are sexually active with WOCBP must agree to follow instructions for methods of contraception 16. Investigators will counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and implications of an unexpected pregnancy. At a minimum subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective: starting at ICF or first dose and continuing 6 months after last dose of trial treatment:
What this trial measures
- Incidence of adverse events24 months
Adverse events will be graded by the Common Terminology Criteria for Adverse Events version 5.0.
- Maximum tolerated dose (MTD) of intrathecal azacitidine in combination with intrathecal nivolumab24 months
The MTD will be established using a 3+3 design.
- Overall Response Rate (Expansion Cohort)24 months
The primary objective of the expansion cohort is to obtain a preliminary estimate of the overall response rate (ORR). ORR will be defined as the proportion of patients with a complete response (CR) or partial response (PR) according to Response Assessment in Neuro-Oncology (RANO) 2.0 criteria