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)

Inclusion

• 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