MedTrace Logo

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

NCT07664176 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-23

No results posted yet for this study

Summary

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.

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

Interventions

DEVICE

NeuroNavigation-Guided Focused Ultrasound (NgFUS)

NeuroNavigation-Guided Focused Ultrasound, every 2 or 4 weeks for 3 cycles of 28 days

DRUG

Lumason

Lumason is a sulfur hexafluoride microsphere ultrasound contrast agent which will be used as a mechanical resonator. Lumason will be given in combination with NgFUS every 2 or 4 weeks for 3 cycles of 28 days.

DRUG

Nivolumab

Nivolumab is a monoclonal antibody targeting the immune checkpoint axis PD-1/PD-L1. Nivolumab will be given prior to NgFUS with microbubbles (Lumason) every 2 or 4 weeks for 3 cycles of 28 days.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-24
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes
FDA Device
Yes

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664176 on ClinicalTrials.gov