Condition: Diffuse Intrinsic Pontine Glioma · Diffuse Midline Glioma, H3 K27M-Mutant · Diffuse Midline Glioma, H3K27-altered · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
This description comes directly from the study's public registry record.
Jacques GRILL, MD, PhD · +33 (0)1 42 11 62 09 · jacques.grill@gustaveroussy.fr
Anne-Sophie BLANC, PharmD · +33 (0)1 42 11 57 02 · annesophie.blanc@gustaveroussy.fr
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| Aarhus Universitetshospital Skejby | Aarhus, Denmark | Recruiting |
| Rigshospitalet | Copenhagen, Denmark | Recruiting |
| H.C. Andersen Children's Hospital, Odense Universitetshospital | Odense, Denmark | Recruiting |
| Gustave Roussy | Villejuif, Val de Marne, France | Recruiting |
| CHU d'Amiens-Picardie Site Sud | Amiens, France | Recruiting |
| Institut de Cancérologie de l'Ouest (ICO) - Site Paul Papin | Angers, France | Recruiting |
| CHU d'Angers - Bâtiment Robert Debré | Angers, France | Recruiting |
| CHU Besançon - Hôpital Jean Minjoz | Besançon, France | Recruiting |
| CHU de Bordeaux - Groupe hospitalier Saint André - Hôpital Saint André | Bordeaux, France | Recruiting |
| CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants | Bordeaux, France | Recruiting |
| CHRU de Brest - Hôpital Morvan | Brest, France | Recruiting |
| CHU de Caen - Hôpital Côte de Nacre | Caen, France | Recruiting |
+ 38 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05476939