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)

March 22, 2023 updated by: Bristol-Myers Squibb

Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Local Institution - 0001
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Local Institution - 0002
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Local Institution - 0003
  • France
      • Lyon, France, 69373 cedex 03
        • Local Institution - 0014
      • Marseille, France, 13385
        • Local Institution - 0016
      • Paris, France, 75005
        • Local Institution - 0015
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Local Institution - 0013
  • Germany
      • Hamburg, Germany, 20246
        • Local Institution - 0038
      • Tuebingen, Germany, 72076
        • Local Institution - 0039
      • Wuerzburg, Germany, 97080
        • Local Institution - 0037
  • Italy
      • Milan, Italy, 20133
        • Local Institution - 0027
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0008
      • Sevilla, Spain, 41013
        • Local Institution - 0059
      • València, Spain, 46026
        • Local Institution - 0028
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28009
        • Local Institution - 0009
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Local Institution - 0029
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A1W Dosing schema
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: A1F Dosing schema
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: A2W Dosing schema
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: A2F Dosing schema
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B1 Neuroblastoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B2 Ewing sarcoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B3 Rhabdomyosarcoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B4 Miscellaneous solid tumors
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B5 NHL/leukemia
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B6 High-grade glioma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B8 Ependymoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)
Experimental: Part B: Cohort B9 Miscellaneous brain tumors
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin (BEMPEG)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From first dose to 42 days after first dose
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)
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.
From first dose to 30 days after last dose (up to approximately 6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of AEs
Time Frame: Up to 5 years
Part B
Up to 5 years
Incidence of SAEs
Time Frame: Up to 5 years
Part B
Up to 5 years
Incidence of drug-related AEs
Time Frame: Up to 5 years
Part B
Up to 5 years
Incidence of AEs leading to discontinuation
Time Frame: Up to 5 years
Part B
Up to 5 years
Incidence of death
Time Frame: Up to 5 years
Part B
Up to 5 years
Incidence of laboratory abnormalities: Hematology tests
Time Frame: Up to 5 years
Part B
Up to 5 years
Incidence of laboratory abnormalities: Clinical chemistry tests
Time Frame: Up to 5 years
Part B
Up to 5 years
Progression-free survival (PFS)
Time Frame: Up to 5 years
Part B
Up to 5 years
Overall survival (OS)
Time Frame: Up to 5 years
Part B
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nektar Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA045-020
  • 2020-000854-85 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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