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Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant

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Trial Profile

Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Everolimus (Primary) ; Ribociclib (Primary) ; Temozolomide (Primary)
  • Indications Anaplastic astrocytoma; Brain cancer; Diffuse intrinsic pontine glioma; Glioblastoma; Glioma; Neuroepithelial neoplasms
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 16 Oct 2025 Planned number of patients changed from 108 to 120.
  • 06 Oct 2025 Inclusion criteria and treatment arms are updated to add Stratum E, comprising patients with H3G34-mutant localized diffuse hemispheric glioma (DHG), being treated with the combination of ribociclib and temozolomide. One more primary end-point is added.
  • 18 Jul 2025 Planned number of patients changed from 100 to 108.

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