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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

    Not yet recruiting

  • First Posted

    January 29, 2021

  • Last update posted

    January 29, 2021

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

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 228 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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)
  • Estimated Study Start Date: April 2021
  • Estimated Primary Completion Date: October 2025
  • Estimated Study Completion Date: October 2025

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, Maryland
Local Institution
Baltimore

United States, Missouri
Local Institution
Saint Louis

Australia, New South Wales
Local Institution
Randwick

Australia, Queensland
Local Institution
South Brisbane

Australia, Victoria
Local Institution
Parkville

Australia, Western Australia
Local Institution
Nedlands

France
Local Institution
Lyon

France
Local Institution
Marseille

France
Local Institution
Paris

France
Local Institution
Villejuif

Germany
Local Institution
Greifswald

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Valencia

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 29, 2021
  • Last Verified: January 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Rhabdomyosarcoma
    Pediatric malignancy
    Pediatric cancer
    Opdivo®
    Non-rhabdomyosarcoma soft-tissue sarcomas
    NIVO
    NKTR-214
    Nivolumab
    Neuroblastoma
    Miscellaneous solid tumors
    Miscellaneous brain tumors
    Melanoma
    Medulloblastoma
    Leukemia and lymphoma
    IL-2 Receptor Agonist
    IL-2
    Immunotherapy
    High-grade glioma (HGG)/diffuse intrinsic pontine glioma (DIPG)
    Ewing sarcoma
    Ependymoma
    Check point inhibitor
    CD122-Biased Cytokine
    CD122-Biased Agonist
    Bempegaldesleukin
    BEMPEG
    B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL)
  • Additional relevant MeSH terms: Medulloblastoma
    Sarcoma, Ewing
    Ependymoma
    Rhabdomyosarcoma
    Neuroblastoma
    Brain Neoplasms
    Glioma
    Sarcoma
    Leukemia
    Neoplasms
    Lymphoma