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NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv4
  2. Recruitment opened Study sites: 0 to 1 · Start date: Aug 24, 2026 to Sep 2026v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Aug 24, 2026 to Sep 2026
  3. Start date: Jun 1, 2026 to Aug 24, 2026v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors. This study combines intravenous nivolumab therapy infused following transient blood-brain barrier opening (BBBO) using low-intensity focused ultrasound with microbubble (LIFU-MB) treatment using NeuroNavigation-Guided Focused Ultrasound (NgFUS). There are two groups in this study: * Group A: Patients with relapsed or progressive diffuse midline glioma in the brainstem * Group B: Patients with relapsed or progressive high grade brain tumor that clinically require surgical resection The primary outcome is to evaluate the safety and feasibility of 3 cycles of nivolumab with BBB disruption using NgFUS with microbubbles in pediatric patients with progressive or relapsed brainstem DMG or with high grade brain tumors after surgery. Secondary outcomes include preliminary efficacy and immunological effects.
Trial Details
NCT Number NCT07664176
Lead Sponsor Children's National Research Institute
Conditions Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma, High Grade Gliomas, Medulloblastoma Recurrent, Ependymoma Recurrent, Atypical Teratoid/Rhabdoid Tumor (ATRT) of the CNS, Brain Tumor Recurrent
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov