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Australian & New Zealand Childrens Haematology/Oncology Group

Clinical Trials

INFORM2 NivEnt: Phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies

Progressive high-risk solid tumours or central nervous system tumours

Status: Open | NSW , VIC , WA

A very small number of childhood tumours have high levels of changes caused by mutations. Where there are a large number of mutations, the child’s immune cells cannot fight the cancer cells effectively. However, these cancers caused by high levels of mutations can be targeted by immunotherapy treatment, called immune checkpoint inhibition.

INFORM2 NivEnt will investigate whether immune checkpoint inhibition (by treatment with nivolumab) re-energises the patient’s immune cells and restores their cancer fighting abilities. This treatment may be further enhanced with a second drug, entinostat, which causes cancer cells to stop reproducing and die.

Disease Stage: Refractory/ relapsed

Patient Age Range: 6 to 21 years of age

Trial Sponsors:

  • International: University of Heidelberg/KiTZ/ITCC
  • National: ANZCHOG

ANZCHOG acknowledges the valuable support of the INFORM2 NivEnt Study by Luminesce Alliance, The Minderoo Foundation and the Australian Brain Cancer Mission