Actively Recruiting
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-02-05
433
Participants Needed
50
Research Sites
465 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
I
Innovative Therapies For Children with Cancer Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of DIPG by clinical and radiological criteria or histological/molecular confirmation including H3K28M mutation or EZHIP overexpression.
- Eligible for biopsy or have biopsy material available for biomarker assessment.
- Age greater than 6 months, with no upper age limit; children between 6 months and 3 years considered individually for biopsy feasibility.
- Eligible for cerebral or craniospinal radiotherapy.
- No prior chemotherapy or cerebral radiation therapy for the current cancer; surgery allowed for diagnosis or therapy.
- Patients with metastatic or spinal tumors allowed; radiotherapy timing adjusted accordingly.
- Affiliated with a social security system or equivalent.
- Written informed consent from patient and/or legal representative and age-appropriate assent obtained as per guidelines.
- Life expectancy greater than 12 weeks after treatment start.
- Karnofsky or Lansky performance status above 50%, excluding neurological deficit as a factor.
- Use of highly effective contraception for patients of reproductive potential during and for 6 months after treatment.
- Negative pregnancy test within one week prior to randomization for sexually active females.
- Adequate blood counts, liver and kidney function, and normal coagulation tests within local reference ranges.
- Written informed consent for randomization obtained according to regulations.
You will not qualify if you...
- Uncontrolled spontaneous massive intratumor bleeding; controlled post-operative bleeding allowed.
- Concurrent anti-cancer treatments not in protocol except corticosteroids and bevacizumab (with restrictions).
- Diagnosis of any other cancer within the last 5 years.
- Uncontrolled illness or active infection.
- Co-morbid conditions impairing study participation as judged by investigator.
- Inability to comply with medical follow-up.
- Previous brainstem irradiation for another cancer.
- Participation in another investigational clinical study during treatment.
- Under legal guardianship or deprived of liberty or unable to consent.
- Current organ toxicity above grade 2, especially cardiac or renal diseases.
- Specific cardiac histories prohibiting ONC201 use, including prolonged QT interval or related risk factors.
- Pregnant or breastfeeding women.
- Known hypersensitivity to everolimus or ONC201 components; such patients assigned to alternate treatment arms.
- Patients with congenital galactose intolerance, lactase deficiency, or glucose-galactose malabsorption assigned to ONC201 arm unless contraindicated.
- Use of strong P450 or PgP inhibitors/inducers requires monitoring or alternative medications during everolimus treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
Aarhus Universitetshospital Skejby
Aarhus, Denmark, 8200
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
H.C. Andersen Children's Hospital, Odense Universitetshospital
Odense, Denmark, 5000
Actively Recruiting
4
Gustave Roussy
Villejuif, Val de Marne, France, 94805
Actively Recruiting
5
CHU d'Amiens-Picardie Site Sud
Amiens, France, 80054
Actively Recruiting
6
Institut de Cancérologie de l'Ouest (ICO) - Site Paul Papin
Angers, France, 49055
Actively Recruiting
7
CHU d'Angers - Bâtiment Robert Debré
Angers, France, 49933
Actively Recruiting
8
CHU Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
9
CHU de Bordeaux - Groupe hospitalier Saint André - Hôpital Saint André
Bordeaux, France, 33000
Actively Recruiting
10
CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants
Bordeaux, France, 33076
Actively Recruiting
11
CHRU de Brest - Hôpital Morvan
Brest, France, 29609
Actively Recruiting
12
CHU de Caen - Hôpital Côte de Nacre
Caen, France, 14033
Actively Recruiting
13
CHU Estaing
Clermont-Ferrand, France, 63003
Actively Recruiting
14
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
15
CHU François Mitterrand
Dijon, France, 21079
Actively Recruiting
16
CHU Grenoble Alpes - Hôpital Albert Michallon
Grenoble, France, 38700
Not Yet Recruiting
17
CHU Grenoble Alpes - Hôpital Couple-Enfant
Grenoble, France, 38700
Actively Recruiting
18
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
19
Hôpital Roger Salengro
Lille, France, 59037
Not Yet Recruiting
20
Hôpital de la mère et de l'enfant
Limoges, France, 87042
Actively Recruiting
21
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
22
Hôpital Pierre Wertheimer
Lyon, France, 69500
Actively Recruiting
23
Hôpital de La Timone
Marseille, France, 13005
Actively Recruiting
24
Hôpital Arnaud de Villeneuve
Montpellier, France, 34090
Actively Recruiting
25
CHRU Nancy - Hôpital central
Nancy, France, 54035
Actively Recruiting
26
CHRU Nancy Brabois - Hôpital d'enfants
Nancy, France, 54500
Actively Recruiting
27
CHU de Nice - Hôpital Pasteur 2
Nice, France, 06000
Actively Recruiting
28
CHU de Nice - Hôpital L'Archet 2
Nice, France, 06202
Actively Recruiting
29
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
30
Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix
Paris, France, 75013
Actively Recruiting
31
Institut Curie
Paris, France, 75248
Actively Recruiting
32
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
33
CHU de Reims - American Memorial Hospital 2
Reims, France, 51092
Actively Recruiting
34
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
35
CHU Rennes - Hôpital Sud
Rennes, France, 35203
Actively Recruiting
36
CHU Rouen Normandie - Hôpital Charles-Nicolle
Rouen, France, 76000
Actively Recruiting
37
CHU de Saint-Denis de La Réunion
Saint-Denis, France, 97400
Actively Recruiting
38
CHU de Saint-Etienne - Hôpital Nord
Saint-Etienne, France, 42270
Actively Recruiting
39
CHU de Saint-Pierre de La Réunion Sud
Saint-Pierre, France, 97488
Not Yet Recruiting
40
Centre Régional Lutte Contre le Cancer Paul STRAUSS
Strasbourg, France, 67065
Actively Recruiting
41
Hôpital de Hautepierre
Strasbourg, France, 67200
Actively Recruiting
42
Hôpital Foch
Suresnes, France, 92150
Not Yet Recruiting
43
Hôpital des enfants
Toulouse, France, 31059
Actively Recruiting
44
Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-O) - Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
45
CHRU Tours - Hôpital Clocheville
Tours, France, 37000
Actively Recruiting
46
CHRU Tours - Hôpital Bretonneau
Tours, France, 37044
Actively Recruiting
47
Hospital Vall D´Hebron
Barcelona, Spain, 8035
Actively Recruiting
48
Hospital Universitario Niño Jesus
Madrid, Spain, 28009
Actively Recruiting
49
Hospital Universitario y Politécnico de La Fe
Valencia, Spain, 46026
Actively Recruiting
50
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
J
Jacques GRILL, MD, PhD
CONTACT
A
Anne-Sophie BLANC, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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