A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
NCT ID: NCT04730349
Last Updated: 2023-03-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2021-06-03
2022-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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A1W Dosing schema
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
A1F Dosing schema
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
A2W Dosing schema
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
A2F Dosing schema
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B1 Neuroblastoma
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B2 Ewing sarcoma
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B3 Rhabdomyosarcoma
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B4 Miscellaneous solid tumors
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B5 NHL/leukemia
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B6 High-grade glioma
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B8 Ependymoma
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Part B: Cohort B9 Miscellaneous brain tumors
Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
NKTR-214
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2020-000854-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA045-020
Identifier Type: -
Identifier Source: org_study_id
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