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NCT04323046 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
A Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Sabine Mueller, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT04323046: Recruiting Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Sabine Mueller, MD, PhD.
NCT04323046 is a Phase 1 study of Glioblastoma and Recurrent Glioblastoma that is actively recruiting participants, run by Sabine Mueller, MD, PhD. The registered enrollment target is 20 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04323046, a Phase 1 study of Glioblastoma and Recurrent Glioblastoma, is actively recruiting participants, sponsored by Sabine Mueller, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Will assess the percentage change in cell cycle-related genetic signature post administration of neoadjuvant treatments when compared to archived recurrent pediatric HGG group. The number of participants with high cell cycle gene signature (positive median gene set variation analysis (GSVA) score) will be tabulated. Variables involved in the primary analyses will be examined graphically and summarized by descriptive statistics.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 1 |
What NCT04323046 shows while recruiting
NCT04323046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (82% lower).
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.
NCT04323046 names 20 study sites across 17 states, led by California, New South Wales, Alabama.
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.
What interventions are being tested in trial NCT04323046?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04323046?
This trial is sponsored by Sabine Mueller, MD, PhD, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04323046's enrollment target sits among peer trials
20 148th of 199 higher than 46 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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