Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
Status:
Not yet recruiting
Trial end date:
2031-09-01
Target enrollment:
Participant gender:
Summary
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 phase-3 controlled 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 disease progression, 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 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.
Phase:
Phase 3
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators:
Chimerix Innovative Therapies For Children with Cancer Consortium