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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04730349
Registration number
NCT04730349
Ethics application status
Date submitted
26/01/2021
Date registered
29/01/2021
Date last updated
24/03/2023
Titles & IDs
Public title
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
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Scientific 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)
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Secondary ID [1]
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2020-000854-85
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Secondary ID [2]
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CA045-020
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Universal Trial Number (UTN)
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Trial acronym
PIVOT IO 020
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ependymoma
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Ewing Sarcoma
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High-grade Glioma
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Leukemia and Lymphoma
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Medulloblastoma
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Miscellaneous Brain Tumors
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Miscellaneous Solid Tumors
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Neuroblastoma
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Relapsed, Refractory Malignant Neoplasms
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Rhabdomyosarcoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Cancer
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Brain
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - NKTR-214
Experimental: A1W Dosing schema -
Experimental: A1F Dosing schema -
Experimental: A2W Dosing schema -
Experimental: A2F Dosing schema -
Experimental: Part B: Cohort B1 Neuroblastoma -
Experimental: Part B: Cohort B2 Ewing sarcoma -
Experimental: Part B: Cohort B3 Rhabdomyosarcoma -
Experimental: Part B: Cohort B4 Miscellaneous solid tumors -
Experimental: Part B: Cohort B5 NHL/leukemia -
Experimental: Part B: Cohort B6 High-grade glioma -
Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors -
Experimental: Part B: Cohort B8 Ependymoma -
Experimental: Part B: Cohort B9 Miscellaneous brain tumors -
Other interventions: Nivolumab
Specified dose on specified days
Other interventions: NKTR-214
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
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Assessment method [1]
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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).
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Timepoint [1]
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From first dose to 42 days after first dose
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Primary outcome [2]
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Number of Participants With Adverse Events (AEs) - Part A
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [3]
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Number of Participants With Serious Adverse Events (SAEs) - Part A
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [4]
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Number of Participants With Drug-Related Adverse Events - Part A
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [5]
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Number of Participants With Adverse Events Leading to Discontinuation - Part A
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Assessment method [5]
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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.
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Timepoint [5]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [6]
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Number of Participants Who Died - Part A
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Assessment method [6]
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Number of participants who died.
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Timepoint [6]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [7]
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Maximum Observed Plasma Concentration (Cmax) - Part A
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Assessment method [7]
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Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
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Timepoint [7]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [8]
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Trough Observed Concentration (Ctrough) - Part A
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Assessment method [8]
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Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
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Timepoint [8]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Primary outcome [9]
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Area Under the Plasma Concentration (AUC) - Part A
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Assessment method [9]
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Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
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Timepoint [9]
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From first dose to 30 days after last dose (up to approximately 6 months)
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/06/2022
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0001 - Randwick
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Recruitment hospital [2]
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Local Institution - South Brisbane
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Recruitment hospital [3]
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Local Institution - 0002 - Parkville
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Recruitment hospital [4]
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Local Institution - 0003 - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment postcode(s) [4]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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France
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State/province [3]
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Val-de-Marne
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Country [4]
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France
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State/province [4]
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Lyon
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Country [5]
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France
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State/province [5]
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Marseille
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Country [6]
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France
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State/province [6]
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Paris
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Country [7]
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Germany
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State/province [7]
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Hamburg
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Country [8]
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Germany
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State/province [8]
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Tuebingen
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Country [9]
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Germany
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State/province [9]
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Wuerzburg
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Country [10]
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Italy
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State/province [10]
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Milan
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Country [11]
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Spain
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State/province [11]
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Madrid, Comunidad De
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Country [12]
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Spain
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State/province [12]
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Barcelona
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Country [13]
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Spain
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State/province [13]
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Sevilla
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Country [14]
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Spain
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State/province [14]
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València
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Nektar Therapeutics
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04730349
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04730349
Download to PDF