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RECRUITING Phase 1

Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults

NCT04323046 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • BIOLOGICAL Nivolumab

Study Locations (20)

California

  • Children's Hospital of Los Angeles — Los Angeles
  • Rady Children's Hospital — San Diego
  • University of California, San Francisco — San Francisco

New South Wales

  • Sydney Children's Hospital — Sydney
  • The Children's Hospital at Westmead — Westmead

Alabama

  • University of Alabama at Birmingham, Children's of Alabama — Birmingham

District of Columbia

  • Children's National Hospital — Washington D.C.

Florida

  • University of Florida — Gainesville

Indiana

  • Riley Children's Hospital — Indianapolis

Maryland

  • Johns Hopkins University — Baltimore

Massachusetts

  • Dana Farber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-10-02
Est. Completion 2029-03-01
Phase Phase 1

Sponsor

Sabine Mueller, MD, PhD

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04323046

The ClinicalTrials.gov registry entry for NCT04323046 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sabine Mueller, MD, PhD, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions — of which Quality-of-Life Assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04323046 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, New South Wales, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04323046 about?

NCT04323046 is a clinical study titled "Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults". This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the...

What is the current status of trial NCT04323046?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-10-02. Estimated completion is 2029-03-01.

What conditions does trial NCT04323046 study?

This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, Malignant Glioma, Recurrent Malignant Glioma, Grade III Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04323046?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04323046?

This trial is sponsored by Sabine Mueller, MD, PhD, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04323046 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial