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

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT05580562
Trial Phases:	Phase III	Protocol IDs:	ONC201-108 (primary) NCI-2023-02479
Eligibility:	0 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Chimerix
NCI Full Details:	http://clinicaltrials.gov/show/NCT05580562

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.

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