NCT04730349
Recruiting
January 29, 2021
January 5, 2022
Brief summary:
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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: A1F Dosing schema |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: A1W Dosing schema |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: A2F Dosing schema |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: A2W Dosing schema |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B1 Neuroblastoma |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B2 Ewing sarcoma |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B3 Rhabdomyosarcoma |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B4 Miscellaneous solid tumors |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B5 NHL/leukemia |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B6 High-grade glioma |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B8 Ependymoma |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
Experimental: Part B: Cohort B9 Miscellaneous brain tumors |
Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 Exclusion Criteria: 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 NOTE: other protocol-defined inclusion/exclusion criteria apply
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Arizona
Local Institution
Phoenix
United States, Arkansas
Arkansas Children's Hospital-Pediatric Hematology/Oncology
Little Rock
United States, California
Local Institution
Los Angeles
United States, California
Local Institution
San Francisco
United States, Colorado
Local Institution
Aurora
United States, Florida
Local Institution
Gainesville
United States, Illinois
Local Institution
Chicago
United States, Indiana
Local Institution
Indianapolis
United States, Maryland
Local Institution
Baltimore
United States, Missouri
Washington University-Pediatric Hematology Oncology
Saint Louis
United States, New York
Local Institution
Bronx
United States, New York
Local Institution
New York
United States, New York
Local Institution
New York
United States, North Carolina
Local Institution
Durham
United States, Pennsylvania
Local Institution
Philadelphia
United States, Wisconsin
Local Institution
Milwaukee
Australia, New South Wales
Local Institution
Randwick
Australia, Queensland
Local Institution
South Brisbane
Australia, Victoria
Local Institution
Parkville
Australia, Western Australia
Local Institution
Nedlands
Canada, British Columbia
Local Institution
Vancouver
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution
Montréal
France
CENTRE LEON BERARD-IHOPE (pediatrric oncology)
Lyon
France
Hopital De La Timone
Marseille
France
Institut Curie
Paris
France
Institut Gustave Roussy
Villejuif
Germany
Local Institution
Greifswald
Germany
Local Institution
Hamburg
Germany
Local Institution
Tuebingen
Germany
Local Institution
Würzburg
Italy
Local Institution
Milano
Italy
Local Institution
Rome
Netherlands
Local Institution
Utrecht
Spain
Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica
Barcelona
Spain
Hospital Infantil Universitario Niño Jesús-Oncohematología
Madrid
Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Oncología pediatrica
Seville
Spain
Hospital Universitari i Politecnic La Fe-Unidad Oncohematología Pediátrica
València
United Kingdom
Local Institution
Birmingham
United Kingdom
Local Institution
Newcastle upon Tyne
United Kingdom
Local Institution
Sutton
Bristol-Myers Squibb
Nektar Therapeutics
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb