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Closed (no longer recruiting)Last updated: 17 May 2024

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)

Clinical 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.


This trial is treating patients with Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Miscellaneous solid cancers, Non-Hodgkin lymphoma, Leukaemia, High-grade glioma, Medulloblastoma and Emrbyonal tumours, Ependymoma and Miscellaneous brain tumours


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Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)



  • Age < 18 years for Part A and Part B
  • Age up to 30 years for Part B Cohorts B2, B3 and B4
  • Must have received standard of care therapy and there must be no potentially curative treatment available
  • Histologically confirmed with malignant neoplasms that are refractory, relapsed, or curative treatments are lacking
  • Must have measurable or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for solid tumors, Response Assessment in Neuro-Oncology (RANO) or Response Assessment in Pediatric Neuro-Oncology (RAPNO) for central nervous system tumors, International Pediatric Non-Hodgkin Lymphoma Response Criteria for non-Hodgkin lymphoma (NHL), revised International Neuroblastoma Response Criteria (INRC) for neuroblastoma, modified National Comprehensive Cancer Network (NCCN) Criteria for acute lymphoblastic leukemia, and modified Cheson et al International Working Group criteria for acute myeloid leukemia
  • Lansky play score for age ≤ 16 years or Karnofsky performance score for age > 16 years assessed within 2 weeks of enrollment must be ≥ 60


  • Osteosarcoma, T-cell/Natural Killer (NK) cell leukemia/lymphoma, and Hodgkin's lymphoma
  • Need for > 2 antihypertensive medications for management of hypertension (including diuretics)
  • Known cardiovascular history, including unstable or deteriorating cardiac disease, within the previous 12 months prior to screening
  • Inadequately treated adrenal insufficiency
  • Active, known, or suspected autoimmune disease
  • Active infection requiring systemic therapy within 14 days prior to first dose
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
  • Prior allogeneic stem cell transplant
  • Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection either suspected or confirmed within 4 weeks prior to screening

Other protocol-defined inclusion/exclusion criteria apply


  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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