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A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (PIVOT IO 020)

  • Clinicaltrials.gov identifier

    NCT04730349

  • Recruitment Status

    Recruiting

  • First Posted

    January 29, 2021

  • Last update posted

    January 5, 2022

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.

  • Condition or Disease:Ependymoma
    Ewing Sarcoma
    High-grade Glioma
    Leukemia and Lymphoma
    Medulloblastoma
    Miscellaneous Brain Tumors
    Miscellaneous Solid Tumors
    Neuroblastoma
    Relapsed, Refractory Malignant Neoplasms
    Rhabdomyosarcoma
  • Intervention/Treatment: Biological: Nivolumab
    Biological: NKTR-214
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 234 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
  • Actual Study Start Date: June 2021
  • Estimated Primary Completion Date: October 2024
  • Estimated Study Completion Date: October 2027

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of dose-limiting toxicities [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • 2. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • 3. Incidence of serious AEs (SAEs) [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • 4. Incidence of drug-related AEs [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • 5. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • 6. Incidence of death [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • 7. Pharmacokinetic (PK) parameters: Peak concentration [ Time Frame: Up to 2 years ]
    Part A
  • 8. Pharmacokinetic (PK) parameters: Trough concentration [ Time Frame: Up to 2 years ]
    Part A
  • 9. Pharmacokinetic (PK) parameters: Time-averaged concentration [ Time Frame: Up to 2 years ]
    Part A
  • 10. Pharmacokinetic (PK) parameters: Clearance (CL) [ Time Frame: Up to 2 years ]
    Part A
  • 11. Pharmacokinetic (PK) parameters: Volume of distribution (Vd) [ Time Frame: Up to 2 years ]
    Part A
  • 12. Investigator-assessed objective response rate (ORR) [ Time Frame: Up to 5 years ]
    Part B
  • Secondary Outcome Measures: 1. Incidence of AEs [ Time Frame: Up to 5 years ]
    Part B
  • 2. Incidence of SAEs [ Time Frame: Up to 5 years ]
    Part B
  • 3. Incidence of drug-related AEs [ Time Frame: Up to 5 years ]
    Part B
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
    Part B
  • 5. Incidence of death [ Time Frame: Up to 5 years ]
    Part B
  • 6. Incidence of laboratory abnormalities: Hematology tests [ Time Frame: Up to 5 years ]
    Part B
  • 7. Incidence of laboratory abnormalities: Clinical chemistry tests [ Time Frame: Up to 5 years ]
    Part B
  • 8. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    Part B
  • 9. Overall survival (OS) [ Time Frame: Up to 5 years ]
    Part B

Eligibility Criteria

  • Ages Eligible for Study: up to 30 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

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 #.

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Nektar Therapeutics

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04730349 History of Changes
  • Other Study ID Numbers: CA045-020, 2020-000854-85
  • First Posted: January 29, 2021 Key Record Dates
  • Last Update Posted: January 5, 2022
  • Last Verified: January 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: 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
  • Additional relevant MeSH terms: Lymphoma
    Neoplasms
    Leukemia
    Sarcoma
    Glioma
    Brain Neoplasms
    Neuroblastoma
    Rhabdomyosarcoma
    Ependymoma
    Sarcoma, Ewing
    Medulloblastoma
    Neoplasms by Histologic Type
    Lymphoproliferative Disorders
    Lymphatic Diseases
    Immunoproliferative Disorders
    Immune System Diseases
    Neoplasms, Connective and Soft Tissue
    Neoplasms, Neuroepithelial
    Neuroectodermal Tumors
    Neoplasms, Germ Cell and Embryonal
    Neoplasms, Glandular and Epithelial
    Neoplasms, Nerve Tissue
    Central Nervous System Neoplasms
    Nervous System Neoplasms
    Neoplasms by Site
    Brain Diseases
    Central Nervous System Diseases
    Nervous System Diseases
    Neuroectodermal Tumors, Primitive, Peripheral
    Neuroectodermal Tumors, Primitive
    Myosarcoma
    Neoplasms, Muscle Tissue
    Osteosarcoma
    Neoplasms, Bone Tissue
    Neoplasms, Connective Tissue