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ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

  • Protocol Number: 202303097
  • Principal Investigator: Cluster, Andrew
  • Cancer Types: Neurological, Siteman Kids- Pediatrics

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief Summary

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.

Protocol Interventions

ONC201, ONC201 + Placebo, Placebo