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Australian & New Zealand Childrens Haematology/Oncology Group

Clinical Trials

PNOC019/NICHE-HGG: A Randomized, Double-Blinded, Pilot Trial of Neoadjuvant Checkpoint Inhibition followed by Combination Adjuvant Checkpoint Inhibition in Children and Young Adults with Recurrent or Progressive

High Grade Glioma(NICHE-HGG)

PNOC019 is a clinical trial for children and young adults who have progressive or recurring high-grade gliomas (HGG). HGGs are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. Immunotherapy has been shown to be a promising treatment for a number of other aggressive cancers.

This study will examine the effectiveness of two immunotherapy agents, nivolumab and ipilimumab taken in differing combinations in some instances also incorporating a placebo. These drugs act as immune checkpoint inhibitors, which help to block a protein that stops the immune system from working properly.

PNOC019 will measure the changes in tumours and compare the results to archived non-treated samples.  The study will also evaluate both the safety of these treatments in children and young adults, and determine the percentage of participants who remain free of tumour regrowth.

Disease stage: Recurrent or Progressive High-Grade Glioma (HGG)

Patient age range: 6 months to 22 years of age

Trial sponsors:

  • National: ANZCHOG
  • International: Pacific Pediatric Neuro-Oncology Consortium