INFORM2: An exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with high risk Malignancies

Project Overview

Brain tumours are the the most common solid tumour type seen in children and is only second most common form of childhood cancer after leukaemia.  Brain tumours include all high-grade gliomas, diffuse intrinsic potine gliomas (DIPG), relapased ependymomas, medulloblastomas, choroid plexus carcinomas and atypical teratoid rhabdoid timours (ATRT).

Approximately, 40 to 50% of children with brian tumours may be eligible to participate in the Zero Childhood Cancer Program. This program is open for infants, children and adolescents with high risk cancers; those with a less than 30% chance of survival.

The Zero Childhood Cancer Program aims to provide actionable diagnostic and prognostic data to the treating oncologists in a clinical relevant timeframe regarding that child’s cancer.  It will provide recommendations to the oncologist on how best to personalise treatment to directly and specifically target the child’s cancer. The Program will also generate an unparalleled, comphrensive and internationally unique dataset that will undoubtedly hold the key to improving long term health outcomes for children with a high risk cancers. However, there is a clear need to further enhance access to novel treatments and most critically, to investigate the use of combination therapies, in order to maximise the impact of the Program on health outcomes.

To address this gap, in collaboration with the German Cancer Reseaerch Centre (DKFZ), in Heidelberg, Germany, the INFORM2 (Individualised Therapies FOr Relapsed Malignacies in Childhood), has been opened in Australia as part of the Zero Childhood Cancer Program. This collaboration will allow those eligibile in the Program access to Nivolumab and Entinostat combination therapy as part of a phase I/II clinical trial.

Luminesce Alliance has secured funding from NSW Health to support INFORM2. The opening of INFORM2 is a critical step in establishing a phase I/II paediatric cancer combination therapy clinical trial in Australia. This will allow Australian children access to a novel drug treatment therapy which was once only available overseas. It is anticipated that INFORM2 will be the first of many clinical trials of its type to be open in Australia. This will reduce the financial and psychological cost to families needing to travel overseas to participate and have access to these therapies.


  • Kids Cancer Centre, Sydney Children’s Hospital Randwick (Australia)
  • The German Cancer Research Center (DKFZ) (Germany)
  • Hopp Children’s Cancer Center at the NCT Heidelberg (KiTZ) (Germany)
  • Children’s Cancer Institute (Australia)
  • The Zero Childhood Cancer Program, National and International Partners (Australia)
  • University of New South Wales Sydney (Australia)
  • Consumer representative groups

INFORM2 will provide Australian children with brain cancer access to novel therapy clinical trials with the aim of improving survival rates and long term outcomes.

Lead Investigators

  • David Ziegler - 328x328@2x

    Associate Professor David Ziegler

    Head, Clinical Trials Program, Kids Cancer Centre, Sydney Children’s Hospital Randwick and Group Leader, Targeted Therapy Group, Children’s Cancer Institute
  • Professor Olaf Witt

    Director Translational Pediatric Oncology Hopp Children's Cancer Center Heidelberg
  • Vanessa Tyrrell

    Personalised Medicine Program Leader, Children’s Cancer Institute