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Safety and Efficacy of NOX66 in combination with Nivolumab for patients with solid tumours – a pilot study (IONIC-1).

ACTRN 12621001537842 

Brief Summary

This trial aims to determine whether NOX66 (idronoxil) can be safely given in combination with nivolumab (an immune checkpoint inhibitor) and to determine the highest dose of NOX66 that can be administered safely.

Intervention/Treatment

  • Drug: NOX66
  • Drug: Nivolumab

Inclusion Criteria

  1. Adult patients with histologically confirmed diagnosis of solid metastatic tumours that are potentially amenable to treatment with nivolumab.
  2. Measurable disease by CT/MRI imaging according to iRECIST and RECIST v1.1.
  3. Patients must have minor disease progression following at least 8 weeks of treatment with a specific checkpoint inhibitor or minor progression whilst on treatment with either chemotherapy or a targeted therapy.
  4. Adequate hepatic, renal and marrow function.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2
  6. Anticipated life-expectancy of at least 6 months.

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