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Trial record 1 of 1 for:    PIVOT IO 020
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730349
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : January 5, 2022
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 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)
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : October 29, 2024
Estimated Study Completion Date : October 29, 2027


Arm Intervention/treatment
Experimental: A1W Dosing schema Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: A1F Dosing schema Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: A2W Dosing schema Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: A2F Dosing schema Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B1 Neuroblastoma Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B2 Ewing sarcoma Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B3 Rhabdomyosarcoma Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B4 Miscellaneous solid tumors Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B5 NHL/leukemia Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B6 High-grade glioma Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B8 Ependymoma Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)

Experimental: Part B: Cohort B9 Miscellaneous brain tumors Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558-01

Biological: NKTR-214
Specified dose on specified days
Other Name: Bempegaldesleukin (BEMPEG)




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730349


Contacts
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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
Show Show 41 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04730349    
Other Study ID Numbers: CA045-020
2020-000854-85 ( EudraCT Number )
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022

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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:
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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