Clinical Trials Logo

Clinical Trial 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, 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05476939
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Jacques GRILL, MD, PhD
Phone +33 (0)1 42 11 62 09
Email jacques.grill@gustaveroussy.fr
Status Recruiting
Phase Phase 3
Start date September 29, 2022
Completion date September 2031

See also
  Status Clinical Trial Phase
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Terminated NCT03330197 - A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG Phase 1/Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Active, not recruiting NCT02992015 - Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma Early Phase 1
Terminated NCT01182350 - Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) Phase 2
Recruiting NCT04837547 - PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy Phase 1
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Completed NCT00879437 - Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma Phase 2
Active, not recruiting NCT02420613 - Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma Phase 1
Completed NCT03086616 - CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009) Phase 1
Recruiting NCT01837862 - A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas Phase 1/Phase 2
Not yet recruiting NCT06093165 - RE-irradiation of Diffuse MIdline Glioma paTients N/A
Withdrawn NCT03632317 - A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas Phase 2
Completed NCT02502708 - Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors Phase 1
Recruiting NCT02233049 - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication Phase 2
Completed NCT00996723 - Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) Phase 1
Recruiting NCT05009992 - Combination Therapy for the Treatment of Diffuse Midline Gliomas Phase 2
Recruiting NCT04049669 - Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG Phase 2
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1