INFORM2 Exploratory Multinational Phase I/II Combination Study of Nivolumab and Entinostat in Children and Adolescents With Refractory High-risk Malignancies (INFORM2-NivEnt)
The INFORM2-NivEnt trial is positioned to explore the efficacy of a novel combination therapy in a pediatric population with high-risk malignancies, a segment with significant unmet medical needs. The trial's focus on specific biomarkers (high mutational load, MYC(N) amplification, high TILs, and TLS) may provide a competitive edge in precision medicine, potentially leading to a differentiated therapeutic profile. Given the limited treatment options for refractory pediatric cancers, successful outcomes could facilitate market entry and establish a strong foothold in a niche yet critical market. The collaboration with University Hospital Heidelberg and the German Cancer Research Center enhances credibility and may attract further investment or partnerships.
Indication: CNS Tumor
Modality: combination therapy
Target: Nivolumab (anti-PD-1) and Entinostat (HDAC inhibitor) targeting immune checkpoint pathways and histone deacetylation mechanisms to enhance anti-tumor immune responses.
Sponsor: University Hospital Heidelberg
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 14, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Nivolumab (anti-PD-1) and Entinostat (HDAC inhibitor) targeting immune checkpoint pathways and histone deacetylation mechanisms to enhance anti-tumor immune responses.
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Condition raw: CNS Tumor, Solid Tumor
Condition normalized: CNS Tumor, Solid Tumor
Modality raw: combination therapy
Modality normalized: combination therapy
Target raw: Nivolumab (anti-PD-1) and Entinostat (HDAC inhibitor) targeting immune checkpoint pathways and histone deacetylation mechanisms to enhance anti-tumor immune responses.
Target normalized: Nivolumab (anti-PD-1) and Entinostat (HDAC inhibitor) targeting immune checkpoint pathways and histone deacetylation mechanisms to enhance anti-tumor immune responses.