PIVOT IO 020: This phase I/II study is evaluating how safe and effective a combined treatment of targeted therapy (Bempegaldesleukin) and immunotherapy (Nivolumab) in children, adolescents and young adults with recurrent or treatment-resistant cancersPhase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

Summary

This is a non-randomised, open-label trial with two parts evaluating Bempegaldesleukin (BEMPEG) in combination with nivolumab. In Part A, the trial is assessing the safety, tolerability and best dose level of the combined treatment. IN Part B, the trial is assessing the efficacy of the treatment amongst different cohorts based on tumour type. The cohorts include: Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Miscellaneous solid tumours, NHL/Leukaemia, High-grade Glioma, Medulloblastoma and Embryonal tumours, Ependymoma, and Miscellaneous brain tumours.