Clinical Trials /

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

NCT04730349

Description:

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.

Related Conditions:
  • Cancer
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
  • Official Title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

Clinical Trial IDs

  • ORG STUDY ID: CA045-020
  • SECONDARY ID: 2020-000854-85
  • NCT ID: NCT04730349

Conditions

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

Interventions

DrugSynonymsArms
NivolumabBMS-936558-01A1F Dosing schema
NKTR-214Bempegaldesleukin (BEMPEG)A1F Dosing schema

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.

Trial Arms

NameTypeDescriptionInterventions
A1W Dosing schemaExperimental
  • Nivolumab
  • NKTR-214
A1F Dosing schemaExperimental
  • Nivolumab
  • NKTR-214
A2W Dosing schemaExperimental
  • Nivolumab
  • NKTR-214
A2F Dosing schemaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B1 NeuroblastomaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B2 Ewing sarcomaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B3 RhabdomyosarcomaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B4 Miscellaneous solid tumorsExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B5 NHL/leukemiaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B6 High-grade gliomaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B7 Medulloblastoma and Embryonal TumorsExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B8 EpendymomaExperimental
  • Nivolumab
  • NKTR-214
Part B: Cohort B9 Miscellaneous brain tumorsExperimental
  • Nivolumab
  • NKTR-214

Eligibility Criteria

        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
      
Maximum Eligible Age:30 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities
Time Frame:Up to 2 years and 100 days
Safety Issue:
Description:Part A

Secondary Outcome Measures

Measure:Incidence of AEs
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Incidence of SAEs
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Incidence of drug-related AEs
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Incidence of AEs leading to discontinuation
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Incidence of death
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Incidence of laboratory abnormalities: Hematology tests
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Incidence of laboratory abnormalities: Clinical chemistry tests
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Progression-free survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:Part B
Measure:Overall survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:Part B

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL)
  • BEMPEG
  • Bempegaldesleukin
  • CD122-Biased Agonist
  • CD122-Biased Cytokine
  • Check point inhibitor
  • Ependymoma
  • Ewing sarcoma
  • High-grade glioma (HGG)/diffuse intrinsic pontine glioma (DIPG)
  • Immunotherapy
  • IL-2
  • IL-2 Receptor Agonist
  • Leukemia and lymphoma
  • Medulloblastoma
  • Melanoma
  • Miscellaneous brain tumors
  • Miscellaneous solid tumors
  • Neuroblastoma
  • Nivolumab
  • NKTR-214
  • NIVO
  • Non-rhabdomyosarcoma soft-tissue sarcomas
  • Opdivo®
  • Pediatric cancer
  • Pediatric malignancy
  • Rhabdomyosarcoma

Last Updated

January 29, 2021