A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma, Medulloblastoma, Miscellaneous Brain Tumors, Miscellaneous Solid Tumors, Neuroblastoma, Relapsed, Refractory Malignant Neoplasms, Rhabdomyosarcoma

In brief

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

Key facts

Study ID

NCT04730349

Run by

Bristol-Myers Squibb

People needed

15

Starts

2021-06-03

Expected to finish

2022-06-22

Last updated by the study team

2023-03-24

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0029 — Little Rock, Arkansas, United States
• Local Institution - 0011 — St Louis, Missouri, United States
• Local Institution - 0001 — Randwick, New South Wales, Australia
• Local Institution — South Brisbane, Queensland, Australia
• Local Institution - 0002 — Parkville, Victoria, Australia
• Local Institution - 0003 — Perth, Western Australia, Australia
• Local Institution - 0013 — Villejuif, Val-de-Marne, France
• Local Institution - 0014 — Lyon, France
• Local Institution - 0016 — Marseille, France
• Local Institution - 0015 — Paris, France
• Local Institution - 0038 — Hamburg, Germany
• Local Institution - 0039 — Tübingen, Germany
• Local Institution - 0037 — Würzburg, Germany
• Local Institution - 0027 — Milan, Italy
• Local Institution - 0009 — Madrid, Madrid, Comunidad de, Spain
• Local Institution - 0008 — Barcelona, Spain
• Local Institution - 0059 — Seville, Spain
• Local Institution - 0028 — Valencia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.