INFORM2 Niv Ent

Immunotherapy for children and adolescents with high-risk refractory cancers - INFORM2-NivEnt

INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies – INFORM2-NivEnt

Recruiting

Summary

Pediatric patients aged 6-21 years with refractory/relapsed/progressive high-risk malignancies with a high mutational load (group A), with high PD-L1 mRNA expression (group B), with MYC(N) amplification (group C) and with a low mutational load, low PD-L1 mRNA expression and no MYC(N) amplification (Biomarker low group D) are eligible for this trial. Extensive molecular profiling (e.g. INFORM Registry) is mandatory before inclusion into the trial. Patients receive a combination therapy with entinostat and nivolumab.

Nivolumab is an immune-checkpoint inhibitor and is already approved in Europe for adults. Entinostat is a novel class I selective HDACi. Clinical trials investigating the combination of nivolumab and entinostat in children have not been reported so far.

In this study the safety and activity of the combination treatment with entinostat and nivolumab for the age groups 6-11 and 12-21 years is evaluated.


Main inclusion criteria

  • Children and adolescents with refractory/relapsed/progressive high-risk malignancies
  • No standard of care treatment available
  • Age at registration ≥ 6 to ≤ 21 years

Sponsor

Heidelberg University Hospital

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