Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0

The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol). It is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls. Two treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until centrally con

Trial Details

NCT ID
NCT05476939
Phase
PHASE3
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Everolimus
  • ONC201
  • Radiotherapy
Locations (sample)
  • Aarhus, Denmark|56.15674,10.21076
  • Copenhagen, Denmark|55.67594,12.56553
  • Odense, Denmark|55.39594,10.38831
  • Villejuif, Val de Marne, France|48.7939,2.35992
  • Amiens, France|49.9,2.3

Key Eligibility Criteria

  • Diagnosis Criteria:
  • Diagnosis of DIPG (clinical and radiological). As biopsy is not standard for these tumors, an informed consent is required for the necessary histol…
  • Histological diagnosis of DIPG (i.e. H3K28M or EZHIP positive Diffuse Midline Glioma located in the pons) in case the tumor biopsy was performed be…
  • Molecular diagnosis of DIPG (i.e. H3K28M) in case a liquid biopsy (CSF or blood) was performed before study entry, in a patient who could not under…

For full eligibility, visit ClinicalTrials.gov.

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