OncoMatch/Clinical Trials/NCT03838042
INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
Is NCT03838042 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Nivolumab and Entinostat for cns tumor.
Treatment: Nivolumab and Entinostat — The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Tumor Agnostic
Biomarker criteria
Allowed: MYC amplification
Group C: Focal MYC(N) amplification based on whole genome sequencing or whole exome sequencing
Allowed: MYCN amplification
Group C: Focal MYC(N) amplification based on whole genome sequencing or whole exome sequencing
Prior therapy
Cannot have received: combination of immune checkpoint inhibitors and HDACi
No prior therapy with the combination of immune checkpoint inhibitors and HDACi
Cannot have received: allogeneic bone marrow, stem cell or organ transplantation
Previous allogeneic bone marrow, stem cell or organ transplantation
Cannot have received: anticancer therapy (chemotherapy, HDACi (including valproic acid), DNA methyltransferase inhibitors, other immunotherapy, targeted therapy, biological response modifiers, endocrine anticancer therapy, radiotherapy)
Any anticancer therapy (e.g., chemotherapy, HDACi (including valproic acid), DNA methyltransferase inhibitors, other immunotherapy, targeted therapy, biological response modifiers, endocrine anticancer therapy or radiotherapy) within 2 weeks or at least 5 half-lives (whichever is longer) of study drug administration.
Lab requirements
Blood counts
absolute granulocytes ≥ 1.0 × 10^9/l (unsupported); platelets ≥ 100 × 10^9/l & stable; hemoglobin ≥ 8 g/dl or ≥ 4.96 mmol/L
Kidney function
serum creatinine ≤ 1.5 x ULN for age
Liver function
Total bilirubin ≤ 1.5 x ULN; AST(SGOT) ≤ 3.0 x ULN; ALT(SGPT) ≤ 3.0 x ULN
Cardiac function
ECG: normal QTc interval according to Bazett formula < 440ms
Laboratory requirements: Hematology: absolute granulocytes ≥ 1.0 × 10^9/l (unsupported); platelets ≥ 100 × 10^9/l & stable; hemoglobin ≥ 8 g/dl or ≥ 4.96 mmol/L. Biochemistry: Total bilirubin ≤ 1.5 x ULN; AST(SGOT) ≤ 3.0 x ULN; ALT(SGPT) ≤ 3.0 x ULN; serum creatinine ≤ 1.5 x ULN for age. ECG: normal QTc interval according to Bazett formula < 440ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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