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

Study acronym: BIOMEDE 2
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial sites expanded: 50 → 53 locationsv14
  2. Enrollment target: 409 to 433
    • Study sites: 42 to 50
    • Eligibility criteria expanded, about 96 words
    • Collaborators reordered
    v13
  3. Study sites: 39 to 42v12
  4. Study sites: 37 to 39v11
  5. Study sites: 36 to 37v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 32 to 36
    • Collaborators: 2 to 3
    v9
  2. Enrollment target: 368 to 409
    • Study sites: 13 to 32
    • Eligibility criteria shortened, about 52 words
    v8
  3. Study sites: 5 to 13v7
  4. Study sites: 2 to 5v6
  5. Study sites: 1 to 2v5
  6. Start date: Sep 30, 2022 to Sep 29, 2022v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Sep 30, 2022
    • Site details revised
    v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 confirmed disease progression (either radiologically or histologically), unacceptable toxicity or consent withdrawal. The final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard.
Trial Details
NCT Number NCT05476939
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: Innovative Therapies For Children with Cancer Consortium, Ministry of Health, France, Jazz Pharmaceuticals
Conditions
(from sponsor)		 Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma, H3K27-altered
Related terms Diffuse Intrinsic Pontine Glioma
Enrollment 433 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov