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Recruiting Phase 2 Interventional

Combination Therapy for the Treatment of Diffuse Midline Gliomas

ClinicalTrials.gov ID: NCT05009992

Public ClinicalTrials.gov record NCT05009992. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial. Novel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).

Study identification

NCT ID
NCT05009992
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
360 participants

Conditions and interventions

Interventions

Drug · Radiation

Eligibility (public fields only)

Age range
2 Years to 39 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 19, 2021
Primary completion
Dec 30, 2027
Completion
Jun 29, 2029
Last update posted
Jun 25, 2026

2021 – 2029

United States locations

U.S. sites
19
U.S. states
17
U.S. cities
19
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 Recruiting
Children's Hospital Los Angeles Los Angeles California 90027 Recruiting
University of California, San Diego / Rady Children's Hospital, San Diego San Diego California 92123 Recruiting
University of California, San Francisco San Francisco California 94143 Recruiting
Children's National Hospital Washington D.C. District of Columbia 20010 Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 Recruiting
Indiana University Riley Children's Hospital Indianapolis Indiana 46202 Recruiting
Johns Hopkins University Baltimore Maryland 21287 Recruiting
Dana-Farber Cancer Institute Harvard University Boston Massachusetts 02215-6024 Recruiting
University of Michigan Ann Arbor Michigan 48109 Recruiting
Children's Hospital Minnesota Minneapolis Minnesota 55404 Recruiting
Washington University in St. Louis St Louis Missouri 63110 Recruiting
Hackensack Meridian Health Hackensack New Jersey 07601 Recruiting
New York University New York New York 10016 Recruiting
Duke University Durham North Carolina 27708 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
University of Utah Salt Lake City Utah 84101 Recruiting
Seattle Children's Hospital Seattle Washington 98101 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05009992, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05009992 live on ClinicalTrials.gov.

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