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Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 — BIOMEDE 2  

Diffuse Intrinsic Pontine Glioma Clinical Trial

Official title:
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

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

Clinical Trial Details
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
View Details
See also
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