OncoMatch/Clinical Trials/NCT05476939
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
Is NCT05476939 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Everolimus and ONC201 for diffuse intrinsic pontine glioma.
Treatment: Everolimus · ONC201 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Intrinsic Pontine Glioma
Glioblastoma
Biomarker criteria
Required: H3F3A (H3 K27M) K27M
H3K28M mutation or loss of H3K28 trimethylation together with EZHIP overexpression
Required: EZHIP overexpression
loss of H3K28 trimethylation together with EZHIP overexpression
Allowed: HIST1H3B K27M
mutation in the histone H3.1, H3.2, H3.3 genes
Allowed: HIST2H3C K27M
mutation in the histone H3.1, H3.2, H3.3 genes
Allowed: H3F3A (H3 K27M) K27M
mutation in the histone H3.1, H3.2, H3.3 genes
Prior therapy
Cannot have received: chemotherapy
no prior chemotherapy for the present cancer
Cannot have received: cerebral radiation therapy
Exception: surgery is allowed when performed for diagnostic or therapeutic purpose
no prior cerebral radiation therapy even for another neoplasm
Cannot have received: irradiation on the brainstem
Patient previously treated with irradiation on the brainstem for another neoplasm
Lab requirements
Blood counts
Absolute neutrophil count > 1.0 x 10^9/l, Platelets > 100 x 10^9/l
Kidney function
Serum creatinine < 1.5 X ULN for age. If serum creatinine > 1.5 x ULN, creatinine clearance must be > 70 ml/min/1.73 m²
Liver function
Total bilirubin < 1.5 x ULN, AST and ALT < 2.5 x ULN
Absolute neutrophil count > 1.0 x 10^9/l, Platelets > 100 x 10^9/l. Total bilirubin < 1.5 x ULN, AST and ALT < 2.5 x ULN. Serum creatinine < 1.5 X ULN for age. If serum creatinine > 1.5 x ULN, creatinine clearance must be > 70 ml/min/1.73 m² (as per local practice). Normal coagulation tests within the local reference ranges.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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