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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730349
Recruitment Status : Terminated (Business objectives have changed)
First Posted : January 29, 2021
Results First Posted : March 24, 2023
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 26, 2021
First Posted Date  ICMJE January 29, 2021
Results First Submitted Date  ICMJE December 21, 2022
Results First Posted Date  ICMJE March 24, 2023
Last Update Posted Date March 24, 2023
Actual Study Start Date  ICMJE June 3, 2021
Actual Primary Completion Date June 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2022)
  • Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A [ Time Frame: From first dose to 42 days after first dose ]
    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).
  • 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) ]
    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.
  • 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) ]
    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.
  • 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) ]
    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.
  • 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) ]
    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.
  • Number of Participants Who Died - Part A [ Time Frame: From first dose to 30 days after last dose (up to approximately 6 months) ]
    Number of participants who died.
  • Maximum Observed Plasma Concentration (Cmax) - Part A [ Time Frame: From first dose to 30 days after last dose (up to approximately 6 months) ]
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
  • Trough Observed Concentration (Ctrough) - Part A [ Time Frame: From first dose to 30 days after last dose (up to approximately 6 months) ]
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
  • Area Under the Plasma Concentration (AUC) - Part A [ Time Frame: From first dose to 30 days after last dose (up to approximately 6 months) ]
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • Incidence of dose-limiting toxicities [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • Incidence of serious AEs (SAEs) [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • Incidence of drug-related AEs [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • Incidence of death [ Time Frame: Up to 2 years and 100 days ]
    Part A
  • Pharmacokinetic (PK) parameters: Peak concentration [ Time Frame: Up to 2 years ]
    Part A
  • Pharmacokinetic (PK) parameters: Trough concentration [ Time Frame: Up to 2 years ]
    Part A
  • Pharmacokinetic (PK) parameters: Time-averaged concentration [ Time Frame: Up to 2 years ]
    Part A
  • Pharmacokinetic (PK) parameters: Clearance (CL) [ Time Frame: Up to 2 years ]
    Part A
  • Pharmacokinetic (PK) parameters: Volume of distribution (Vd) [ Time Frame: Up to 2 years ]
    Part A
  • Investigator-assessed objective response rate (ORR) [ Time Frame: Up to 5 years ]
    Part B
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • Incidence of AEs [ Time Frame: Up to 5 years ]
    Part B
  • Incidence of SAEs [ Time Frame: Up to 5 years ]
    Part B
  • Incidence of drug-related AEs [ Time Frame: Up to 5 years ]
    Part B
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
    Part B
  • Incidence of death [ Time Frame: Up to 5 years ]
    Part B
  • Incidence of laboratory abnormalities: Hematology tests [ Time Frame: Up to 5 years ]
    Part B
  • Incidence of laboratory abnormalities: Clinical chemistry tests [ Time Frame: Up to 5 years ]
    Part B
  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    Part B
  • Overall survival (OS) [ Time Frame: Up to 5 years ]
    Part B
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ependymoma
  • Ewing Sarcoma
  • High-grade Glioma
  • Leukemia and Lymphoma
  • Medulloblastoma
  • Miscellaneous Brain Tumors
  • Miscellaneous Solid Tumors
  • Neuroblastoma
  • Relapsed, Refractory Malignant Neoplasms
  • Rhabdomyosarcoma
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Name: BMS-936558-01
  • Biological: NKTR-214
    Specified dose on specified days
    Other Name: Bempegaldesleukin (BEMPEG)
Study Arms  ICMJE
  • Experimental: A1W Dosing schema
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: A1F Dosing schema
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: A2W Dosing schema
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: A2F Dosing schema
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B1 Neuroblastoma
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B2 Ewing sarcoma
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B3 Rhabdomyosarcoma
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B4 Miscellaneous solid tumors
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B5 NHL/leukemia
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B6 High-grade glioma
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B8 Ependymoma
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
  • Experimental: Part B: Cohort B9 Miscellaneous brain tumors
    Interventions:
    • Biological: Nivolumab
    • Biological: NKTR-214
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2022)		 15
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)		 228
Actual Study Completion Date  ICMJE June 22, 2022
Actual Primary Completion Date June 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Germany,   Italy,   Spain,   United States
Removed Location Countries Canada,   Netherlands,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT04730349
Other Study ID Numbers  ICMJE CA045-020
2020-000854-85 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Nektar Therapeutics
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP