The current clinical trial is a 3-year trial that began in September 2017. By the end of 2020, the total number of children enrolled is expected to reach over 400 and extension of this trial has been approved, which will allow us to continue to enrol patients without interruption The current trial is open to all children and young people up to 21 years of age who have high-risk or relapsed cancer. These are children who have aggressive cancers which have not responded to treatment, and who face a less than 30% chance of survival.
The aim of the clinical trial is to test the practicality and impact of providing a comprehensive testing platform (including genomic analysis, drug screening and drug testing) to identify personalised treatments for children and adolescents with high-risk cancer.
Which organisations are involved?
The clinical trial is being run in partnership by Children’s Cancer Institute and Kids Cancer Centre at Sydney Children’s Hospital, Randwick and involves a large number of research and clinical collaborators.
All eight children’s hospitals in Australia are part of the national clinical trial as well as 23 national and international research partners, including some of the world’s leading medical research institutes.
The national coordinating site for the trial is the Kids Oncology and Leukaemia trials (KOALA) unit at Kids Cancer Centre, Sydney Children’s Hospital. The National Cancer Cooperative Clinical Trials Group for childhood cancer and the peak professional body for paediatric oncologists and other healthcare professionals who care for children with cancer - The Australian and New Zealand Children’s Haematology and Oncology Group (ANZCHOG) - endorses ZERO and is the national trial sponsor.
How is the trial being funded?
Initial funding for the current clinical trial was provided by the Australian federal government and the government-funded Cancer Therapeutics Cooperative Research Centre (CTx), while the NSW state government contributed capital funding. Additional support has also been provided by our multiple funding partners.
What has the trial achieved?
The clinical trial has achieved very promising results to date:
- Following sample analysis and testing, the ZERO team has been able to provide a potentially actionable personalised treatment plan for almost three quarters (>70%) of participating children.
- Personalised treatment recommendations have been provided in a turnaround time on average of less than nine weeks from the time of sample arrival in 2020.
- For the first group of children for whom follow-up data is available, approximately 70% have had a complete or partial response to personalised treatment, or their disease has been stabilised.
Given that children participating in the trial have exhausted all other treatment options and have a less than 30% chance of survival, these results are remarkable and have exceeded our expectations.
ZERO is changing the model of care for children with cancer by identifying potential new treatments specifically targeted to each child’s individual cancer and facilitating access to the right drug for the right child at the right time. Children are alive today who would have died without ZERO.
The new clinical trial
Building on the success of the first three years of the PRISM trial, we will now expand access to and enhance the program over the next 3 years. This expansion has been made possible as a result of funding support by the Australian Government’s Medical Research Future Fund (MRFF) Emerging Priorities and Consumer Driven Research Initiative (EPCDR) and the Minderoo Foundation’s Collaborate Against Cancer Initiative , announced in April 2020. Excitingly, the new trial will not only include children with high-risk cancer, it will be expanded over time to be accessible to all children with cancer .
By the end of 2023, all Australian children and young people with cancer will be able to benefit from ZERO, regardless of the cancer they have. For the first time, every child diagnosed with cancer will have access to personalised medicine.