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NCT04730349 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2023-03-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

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outcome · POSTED

Number of Participants With Adverse Events (AEs) - Part A

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outcome · POSTED

Number of Participants With Serious Adverse Events (SAEs) - Part A

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outcome · POSTED

Number of Participants With Drug-Related Adverse Events - Part A

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outcome · POSTED

Number of Participants With Adverse Events Leading to Discontinuation - Part A

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outcome · POSTED

Number of Participants Who Died - Part A

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax) - Part A

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outcome · POSTED

Trough Observed Concentration (Ctrough) - Part A

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outcome · POSTED

Area Under the Plasma Concentration (AUC) - Part A

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
30 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    A1W Dosing schema
    type
    EXPERIMENTAL
  2. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    A1F Dosing schema
    type
    EXPERIMENTAL
  3. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    A2W Dosing schema
    type
    EXPERIMENTAL
  4. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    A2F Dosing schema
    type
    EXPERIMENTAL
  5. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B1 Neuroblastoma
    type
    EXPERIMENTAL
  6. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B2 Ewing sarcoma
    type
    EXPERIMENTAL
  7. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B3 Rhabdomyosarcoma
    type
    EXPERIMENTAL
  8. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B4 Miscellaneous solid tumors
    type
    EXPERIMENTAL
  9. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B5 NHL/leukemia
    type
    EXPERIMENTAL
  10. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B6 High-grade glioma
    type
    EXPERIMENTAL
  11. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
    type
    EXPERIMENTAL
  12. intervention Names
    1. Biological: Nivolumab
    2. Biological: NKTR-214
    label
    Part B: Cohort B8 Ependymoma
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. A1F Dosing schema
    2. A1W Dosing schema
    3. A2F Dosing schema
    4. A2W Dosing schema
    5. Part B: Cohort B1 Neuroblastoma
    6. Part B: Cohort B2 Ewing sarcoma
    7. Part B: Cohort B3 Rhabdomyosarcoma
    8. Part B: Cohort B4 Miscellaneous solid tumors
    9. Part B: Cohort B5 NHL/leukemia
    10. Part B: Cohort B6 High-grade glioma
    11. Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
    12. Part B: Cohort B8 Ependymoma
    description
    Specified dose on specified days
    name
    Nivolumab
    other Names
    1. BMS-936558-01
    type
    BIOLOGICAL
  2. arm Group Labels
    1. A1F Dosing schema
    2. A1W Dosing schema
    3. A2F Dosing schema
    4. A2W Dosing schema
    5. Part B: Cohort B1 Neuroblastoma
    6. Part B: Cohort B2 Ewing sarcoma
    7. Part B: Cohort B3 Rhabdomyosarcoma
    8. Part B: Cohort B4 Miscellaneous solid tumors
    9. Part B: Cohort B5 NHL/leukemia
    10. Part B: Cohort B6 High-grade glioma
    11. Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
    12. Part B: Cohort B8 Ependymoma
    description
    Specified dose on specified days
    name
    NKTR-214
    other Names
    1. Bempegaldesleukin (BEMPEG)
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
15
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).
    measure
    Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
    time Frame
    From first dose to 42 days after first dose
  2. description
    Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    measure
    Number of Participants With Adverse Events (AEs) - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  3. description
    Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
    measure
    Number of Participants With Serious Adverse Events (SAEs) - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  4. description
    Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    measure
    Number of Participants With Drug-Related Adverse Events - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  5. description
    Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    measure
    Number of Participants With Adverse Events Leading to Discontinuation - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  6. description
    Number of participants who died.
    measure
    Number of Participants Who Died - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  7. description
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
    measure
    Maximum Observed Plasma Concentration (Cmax) - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  8. description
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
    measure
    Trough Observed Concentration (Ctrough) - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
  9. description
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
    measure
    Area Under the Plasma Concentration (AUC) - Part A
    time Frame
    From first dose to 30 days after last dose (up to approximately 6 months)
Full study description
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.
Source references
see Also Links
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
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        exact text
        NCT04730349
        start
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      offset unit
      unicode_code_points
      query cond
      Diffuse Intrinsic Pontine Glioma (DIPG)
      query disease state id
      ds-diffuse-intrinsic-pontine-glioma-dipg
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-diffuse-intrinsic-pontine-glioma-dipg-000.json
      source file sha256
      25fcad6f9e36b53fbec5681d57a4d8fa91f6d5505f2bd8ac1ccfa9650fb620f1
      source json pointer
      /studies/0/protocolSection/identificationModule/nctId
      source kind
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      source record id
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      source string sha256
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    Preserved source evidence · Not medical advice