ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) (NCT05580562)
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Phoenix, Arizona
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (162 Sites)
Showing the first 25 of 162 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
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- UCLA University of California Los Angeles — Los Angeles, California
- Children's Hospital of Orange County — Orange, California
- University of California Irvine — Orange, California
- UCSF Benioff Children's Hospital — San Francisco, California
- University of California San Francisco — San Francisco, California
- Providence Saint John's Cancer Institute — Santa Monica, California
- Stanford Cancer Center — Stanford, California
- Yale University — New Haven, Connecticut
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Miami Cancer Institute — Miami, Florida
- St Joseph's Children's Hospital of Tampa — Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida
- Cleveland Clinic Florida — Weston, Florida
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Kapi'olani Medical Center for Women and Children — Honolulu, Hawaii
- Feinberg School of Medicine Northwestern University — Chicago, Illinois
- Indiana University School of Medicine - Indianapolis — Indianapolis, Indiana
- University of Iowa Hospitals & Clinics — Iowa City, Iowa
📞 Contact the Study Coordinator
Phone: (215) 832-3750
Email: ClinicalTrialDisclosure@jazzpharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All H3 K27M clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.