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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 30 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Other protocol-defined inclusion/exclusion criteria apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04730349
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bristol-Myers Squibb
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Terminated
Countries	Australia, France, Germany, Italy, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma, Medulloblastoma, Miscellaneous Brain Tumors, Miscellaneous Solid Tumors, Neuroblastoma, Relapsed, Refractory Malignant Neoplasms, Rhabdomyosarcoma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: A1W Dosing schema

Experimental: A1F Dosing schema

Experimental: A2W Dosing schema

Experimental: A2F Dosing schema

Experimental: Part B: Cohort B1 Neuroblastoma

Experimental: Part B: Cohort B2 Ewing sarcoma

Experimental: Part B: Cohort B3 Rhabdomyosarcoma

Experimental: Part B: Cohort B4 Miscellaneous solid tumors

Experimental: Part B: Cohort B5 NHL/leukemia

Experimental: Part B: Cohort B6 High-grade glioma

Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors

Experimental: Part B: Cohort B8 Ependymoma

Experimental: Part B: Cohort B9 Miscellaneous brain tumors

Interventions

Biological: - Nivolumab

Specified dose on specified days

Biological: - NKTR-214

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution - 0029, Little Rock, Arkansas

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Local Institution - 0029

Little Rock, Arkansas, 72202

Local Institution - 0011, Saint Louis, Missouri

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Local Institution - 0011

Saint Louis, Missouri, 63110

International Sites

Local Institution - 0001, Randwick, New South Wales, Australia

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Local Institution - 0001

Randwick, New South Wales, 2031

Local Institution, South Brisbane, Queensland, Australia

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Local Institution

South Brisbane, Queensland, 4101

Local Institution - 0002, Parkville, Victoria, Australia

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Local Institution - 0002

Parkville, Victoria, 3052

Local Institution - 0003, Perth, Western Australia, Australia

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Local Institution - 0003

Perth, Western Australia, 6009

Local Institution - 0013, Villejuif, Val-de-Marne, France

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Local Institution - 0013

Villejuif, Val-de-Marne, 94805

Local Institution - 0014, Lyon, France

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Local Institution - 0014

Lyon, , 69373 cedex 03

Local Institution - 0016, Marseille, France

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Local Institution - 0016

Marseille, , 13385

Local Institution - 0015, Paris, France

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Local Institution - 0015

Paris, , 75005

Local Institution - 0038, Hamburg, Germany

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Local Institution - 0038

Hamburg, , 20246

Local Institution - 0039, Tuebingen, Germany

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Local Institution - 0039

Tuebingen, , 72076

Local Institution - 0037, Wuerzburg, Germany

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Local Institution - 0037

Wuerzburg, , 97080

Local Institution - 0027, Milan, Italy

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Local Institution - 0027

Milan, , 20133

Local Institution - 0009, Madrid, Madrid, Comunidad De, Spain

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Local Institution - 0009

Madrid, Madrid, Comunidad De, 28009

Local Institution - 0008, Barcelona, Spain

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Local Institution - 0008

Barcelona, , 08035

Local Institution - 0059, Sevilla, Spain

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Local Institution - 0059

Sevilla, , 41013

Local Institution - 0028, València, Spain

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Local Institution - 0028

València, , 46026

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