INFORM2 NivEnt
Phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies
Bone Cancers (Ewing Sarcoma/Osteosarcoma), Brain and other Central Nervous System (CNS) Tumours, Germ Cell Tumours, Kidney (Renal) Tumours, Liver tumours, Neuroblastoma, Soft Tissue Sarcomas
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
Sites
Children’s Hospital at Westmead
Perth Children’s Hospital
The Royal Children’s Hospital, Melbourne
Sydney Children’s Hospital