A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
With
Nektar Therapeutics
Age
0–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
