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

    Summary
    EudraCT number
    		 2020-000854-85
    Trial protocol
    		 FR   ES   DE   IT   Outside EU/EEA  
    Global end of trial date
    22 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2023
    First version publication date
    06 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA045-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04730349
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002492-PIP01-18
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of bempegaldesleukin (bempeg; NKTR-214) in combination with nivolumab (nivo) in pediatric participants with malignant neoplasms that were refractory, or relapsed, or in participants for whom curative treatments are lacking.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    15
    EEA total number of subjects
    9
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    7
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 15 participants were treated in Part A. Study did not progress to Part B; therefore, no participants enrolled in Part B.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
    Arm description
    		 Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bempegaldesleukin (NKTR-214)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bempegaldesleukin 0.006 mg/kg administered intravenously every 3 weeks

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 4.5 mg/kg administered intravenously every 3 weeks

    Arm title
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Arm description
    		 Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 360 mg administered intravenously every 3 weeks

    Investigational medicinal product name
    Bempegaldesleukin (NKTR-214)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bempegaldesleukin 0.006 mg/kg administered intravenously every 3 weeks

    Number of subjects in period 1
    		Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Started
    8
    7
    Completed
    1
    2
    Not completed
    7
    5
         Disease progression
    6
    4
         Participant withdrew consent
    1
    -
         Study drug toxicity
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
    Reporting group description
    		 Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks

    Reporting group title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Reporting group description
    		 Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks

    Reporting group values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) Total
    Number of subjects
    		 8 7 15
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 7 0 7
        Adolescents (12-17 years)
    		 1 7 8
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 7.5 ( 3.9 ) 14.9 ( 1.5 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 4 2 6
        Male
    		 4 5 9
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 4 6 10
        Unknown or Not Reported
    		 3 1 4
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 6 5 11
        Black or African American
    		 1 0 1
        Other
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
    Reporting group description
    		 Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks

    Reporting group title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Reporting group description
    		 Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks

    Primary: Number of Participants with Dose-Limiting Toxicities (DLTs) - Part A

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    End point title
    		 Number of Participants with Dose-Limiting Toxicities (DLTs) - Part A [1]
    End point description
    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).
    End point type
    Primary
    End point timeframe
    From first dose to 42 days after first dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    8
    7
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Adverse Events (AEs) - Part A

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    End point title
    		 Number of Participants with Adverse Events (AEs) - Part A [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    8
    7
    Units: Participants
    8
    7
    No statistical analyses for this end point

    Primary: Number of Participants with Serious Adverse Events (SAEs) - Part A

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    End point title
    		 Number of Participants with Serious Adverse Events (SAEs) - Part A [3]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    8
    7
    Units: Participants
    6
    5
    No statistical analyses for this end point

    Primary: Number of Participants with Drug-Related Adverse Events - Part A

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    End point title
    		 Number of Participants with Drug-Related Adverse Events - Part A [4]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    8
    7
    Units: Participants
    6
    6
    No statistical analyses for this end point

    Primary: Number of Participants with Adverse Events Leading to Discontinuation - Part A

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    End point title
    		 Number of Participants with Adverse Events Leading to Discontinuation - Part A [5]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    8
    7
    Units: Participants
    2
    3
    No statistical analyses for this end point

    Primary: Number of Participants Who Died - Part A

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    End point title
    		 Number of Participants Who Died - Part A [6]
    End point description
    Number of participants who died.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    8
    7
    Units: Participants
    2
    0
    No statistical analyses for this end point

    Primary: Maximum Observed Plasma Concentration (Cmax) - Part A

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) - Part A [7]
    End point description
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [8] - Study terminated. PK samples not shipped for bioanalytical analysis. No PK data generated.
    [9] - Study terminated. PK samples not shipped for bioanalytical analysis. No PK data generated.
    No statistical analyses for this end point

    Primary: Primary: Trough Observed Concentration (Ctrough) - Part A

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    End point title
    		 Primary: Trough Observed Concentration (Ctrough) - Part A [10]
    End point description
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [11] - Study terminated. PK samples not shipped for bioanalytical analysis. No PK data generated.
    [12] - Study terminated. PK samples not shipped for bioanalytical analysis. No PK data generated.
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration (AUC) - Part A

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    End point title
    		 Area Under the Plasma Concentration (AUC) - Part A [13]
    End point description
    Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days after last dose (up to approximately 6 months)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: hour*ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [14] - Study terminated. PK samples not shipped for bioanalytical analysis. No PK data generated.
    [15] - Study terminated. PK samples not shipped for bioanalytical analysis. No PK data generated.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants assessed for all-cause mortality from first dose to study completion (up to approximately 13 months). SAEs and NSAEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
    Reporting group description
    		 -

    Reporting group title
    Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
    Reporting group description
    		 -

    Serious adverse events
    		 Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    8 / 8 (100.00%)
         number of deaths (all causes)
    2
    7
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    2 / 7 (28.57%)
    6 / 8 (75.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 6
    Injury, poisoning and procedural complications
    Skin wound
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    8 / 8 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 7 (28.57%)
    4 / 8 (50.00%)
         occurrences all number
    8
    4
    Generalised oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 8 (25.00%)
         occurrences all number
    6
    3
    Pain
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Scrotal oedema
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Nasal congestion
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Lung disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pneumothorax
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pneumonitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Behaviour disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 8 (12.50%)
         occurrences all number
    8
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    White blood cell count decreased
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 8 (0.00%)
         occurrences all number
    6
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Ligament sprain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Ataxia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Neuralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    2 / 7 (28.57%)
    3 / 8 (37.50%)
         occurrences all number
    3
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 8 (12.50%)
         occurrences all number
    7
    1
    Eosinophilia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Febrile neutropenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Photophobia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 8 (0.00%)
         occurrences all number
    5
    0
    Tooth discolouration
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 8 (25.00%)
         occurrences all number
    5
    2
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Urticaria
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 8 (37.50%)
         occurrences all number
    1
    4
    Pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Hyperthyroidism
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Bone pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Infections and infestations
    Lymphangitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 8 (0.00%)
         occurrences all number
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2021
    Updated the minimum days from “100” to “150” days following discontinuation of drug for collection of all serious adverse events (SAEs) and Non-Serious Adverse Events (NSAEs).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated on 22-Jun-2022. This results disclosure report provides analyses from CA045-020 Part A safety analyses only. Part B of the study (expansion phase) did not enroll any participants.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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