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Study identifier: NCT05580562 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

Condition: H3 K27M · Glioma  ·  Sponsor: Jazz Pharmaceuticals

PhasePhase 3
Planned participants510
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trial Disclosure & Transparency  ·  215-832-3750  ·  ClinicalTrialDisclosure@jazzpharma.com

Always discuss trial participation with your own doctor first.

Locations (162)

Banner MD Anderson Cancer CenterPhoenix, Arizona, United StatesCompleted
Barrow Neurological InstitutePhoenix, Arizona, United StatesActive Not Recruiting
Phoenix Childrens HospitalPhoenix, Arizona, United StatesCompleted
Mayo Clinic ArizonaPhoenix, Arizona, United StatesCompleted
UC San Diego Moores Cancer CenterLa Jolla, California, United StatesActive Not Recruiting
Kaiser Permanente Los Angeles Medical CenterLos Angeles, California, United StatesCompleted
UCLA University of California Los AngelesLos Angeles, California, United StatesCompleted
Children's Hospital of Orange CountyOrange, California, United StatesCompleted
University of California IrvineOrange, California, United StatesActive Not Recruiting
UCSF Benioff Children's HospitalSan Francisco, California, United StatesActive Not Recruiting
University of California San FranciscoSan Francisco, California, United StatesActive Not Recruiting
Providence Saint John's Cancer InstituteSanta Monica, California, United StatesActive Not Recruiting

+ 150 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05580562