Comparing two drugs, ONC201 and everolimus, for DIPG
Official title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study compares two drugs to see which one holds the tumor back longer.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT05476939
- Stage of testing
- Phase 3
- Conditions studied
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma, H3K27-altered
Where it is running
This trial lists 53 sites.
-
Denmark
- Aarhus Universitetshospital Skejby (Aarhus)
- Rigshospitalet (Copenhagen)
- H.C. Andersen Children's Hospital, Odense Universitetshospital (Odense)
-
Finland
- Helsinki University Hospital (Helsinki)
-
France
- CHU d'Amiens-Picardie Site Sud (Amiens)
- Institut de Cancérologie de l'Ouest (ICO) - Site Paul Papin (Angers)
- CHU d'Angers - Bâtiment Robert Debré (Angers)
- CHU Besançon - Hôpital Jean Minjoz (Besançon)
- CHU de Bordeaux - Groupe hospitalier Saint André - Hôpital Saint André (Bordeaux)
- CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants (Bordeaux)
- CHRU de Brest - Hôpital Morvan (Brest)
- CHU de Caen - Hôpital Côte de Nacre (Caen)
- CHU Estaing (Clermont-Ferrand)
- Centre Jean Perrin (Clermont-Ferrand)
- CHU François Mitterrand (Dijon)
- CHU Grenoble Alpes - Hôpital Albert Michallon (Grenoble)
- and 30 more in France
-
Norway
- Oslo University Hospital, Rikshospitalet (Oslo)
- Oslo University Hospital, Radiumhospitalet (Oslo)
-
Spain
- Hospital Vall D´Hebron (Barcelona)
- Hospital Universitario Niño Jesus (Madrid)
- Hospital Universitario y Politécnico de La Fe (Valencia)
-
Sweden
- Karolinska University Hospital (Stockholm)
-
Val de Marne
- Gustave Roussy (Villejuif)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.