OncoMatch/Clinical Trials/NCT05580562
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Is NCT05580562 recruiting? Yes, currently enrolling (May 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 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
Cancer type
Glioblastoma
Biomarker criteria
Required: H3F3A (H3 K27M) K27M mutation
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 mutation
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: ONC201 (ONC201)
ONC201 at any time
Cannot have received: ONC206 (ONC206)
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: alkylating agent (temozolomide)
Temozolomide within past 3 weeks
Cannot have received: tumor treating fields
Tumor treating fields at any time
Cannot have received: dopamine receptor D2 antagonist
DRD2 antagonist within past 2 weeks
Cannot have received: investigational therapy
Any investigational therapy within past 4 weeks
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0 × 10^9/L; platelets ≥ 75 × 10^9/L
Kidney function
Creatinine clearance > 60 mL/min as calculated by Cockcroft Gault equation (or eGFR ≥ 60 mL/min/1.73 m2)
Liver function
Total bilirubin ≤ 1.5 × ULN (participants with Gilbert's syndrome may be included with total bilirubin > 1.5 × ULN if direct bilirubin is ≤ 1.5 × ULN); AST or ALT ≤ 2.5 × ULN
Cardiac function
QTc ≤ 480 msec (mean from triplicate ECGs)
Absolute neutrophil count < 1.0 × 10^9/L or platelets < 75 × 10^9/L [excluded]. Total bilirubin > 1.5 × ULN (participants with Gilbert's syndrome may be included with total bilirubin > 1.5 × ULN if direct bilirubin is ≤ 1.5 × ULN) [excluded]. AST or ALT > 2.5 × ULN [excluded]. Creatinine clearance ≤ 60 mL/min as calculated by Cockcroft Gault equation (or eGFR < 60 mL/min/1.73 m2) [excluded]. QTc > 480 msec (mean from triplicate ECGs) [excluded].
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 →
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