OncoMatch/Clinical Trials/NCT05580562
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Is NCT05580562 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies Dordaviprone (ONC201) for h3 k27m.
Treatment: Dordaviprone (ONC201) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: H3F3A (H3 K27M) k27m
Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS])
Required: HIST1H3B k27m
Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS])
Required: HIST1H3C k27m
Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS])
Prior therapy
Must have received: radiation therapy — frontline
Received frontline radiotherapy
Cannot have received: whole-brain radiotherapy
Received whole-brain radiotherapy
Cannot have received: proton therapy
Received proton therapy for glioma
Cannot have received: Dordaviprone (ONC201) or ONC206 (ONC201, ONC206)
Dordaviprone (ONC201) or ONC206 at any time
Cannot have received: anti-VEGF therapy (bevacizumab)
Systemic bevacizumab (includes biosimilars) at any time since the initial diagnosis of H3 K27M-mutant diffuse glioma
Cannot have received: tumor treating fields
Tumor treating fields at any time
Lab requirements
Blood counts
Absolute neutrophil count < 1.0 × 10^9/L or platelets < 75 × 10^9/L
Kidney function
Creatinine clearance ≤ 60 mL/min (Cockcroft Gault) or eGFR < 60 mL/min/1.73 m2
Liver function
AST or ALT > 2.5 × ULN; total bilirubin > 1.5 × ULN (Gilbert's syndrome exception: direct bilirubin ≤ 1.5 × ULN)
Cardiac function
QTc > 480 msec (mean from triplicate ECGs)
Laboratory test results meeting any of the following parameters within 2 weeks prior to randomization: Absolute neutrophil count < 1.0 × 10^9/L or platelets < 75 × 10^9/L. Total bilirubin > 1.5 × ULN (Gilbert's syndrome exception: direct bilirubin ≤ 1.5 × ULN). AST or ALT > 2.5 × ULN. Creatinine clearance ≤ 60 mL/min (Cockcroft Gault) or eGFR < 60 mL/min/1.73 m2. QTc > 480 msec (mean from triplicate ECGs).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Phoenix, Arizona
- Barrow Neurological Institute · Phoenix, Arizona
- Phoenix Childrens Hospital · Phoenix, Arizona
- Mayo Clinic Arizona · Phoenix, Arizona
- UC San Diego Moores Cancer Center · La Jolla, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05580562 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior whole-brain radiotherapy, proton therapy, Dordaviprone (ONC201) or ONC206 disqualifies patients from enrollment.
Does this trial require H3F3A?
Yes, H3F3A k27m is a required biomarker for enrollment.
Does this trial require HIST1H3B?
Yes, HIST1H3B k27m is a required biomarker for enrollment.
Does this trial require HIST1H3C?
Yes, HIST1H3C k27m is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages