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    Clinical Trial Results:
    A Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumabin subjects with advanced cancers

    Summary
    EudraCT number
    		 2019-004194-95
    Trial protocol
    		 FR   GB   ES   PL   IT  
    Global end of trial date
    19 Dec 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jan 2025
    First version publication date
    26 Dec 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Errors identified and required to be addressed.

    Trial information

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    Trial identification
    Sponsor protocol code
    CC-90011-ST-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04350463
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium,
    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)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to assess the safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1or 2 lines of therapy.
    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
    12 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Spain: 46
    Worldwide total number of subjects
    92
    EEA total number of subjects
    76
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    51
    From 65 to 84 years
    40
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled in 6 countries.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A 40 mg
    Arm description
    		 Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab was administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60 minute infusion

    Investigational medicinal product name
    CC-90011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg capsule administered orally

    Arm title
    		 Cohort A 60mg
    Arm description
    		 Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab was administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60 minute infusion

    Investigational medicinal product name
    CC-90011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg capsule administered orally

    Arm title
    		 Cohort B 40 mg
    Arm description
    		 Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab was administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60 minute infusion

    Investigational medicinal product name
    CC-90011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg capsule administered orally

    Arm title
    		 Cohort C
    Arm description
    		 Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab was administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60 minute infusion

    Investigational medicinal product name
    CC-90011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg capsule administered orally

    Number of subjects in period 1
    		Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Started
    39
    2
    14
    37
    Completed
    8
    0
    0
    2
    Not completed
    31
    2
    14
    35
         Adverse event, serious fatal
    27
    2
    13
    26
         Consent withdrawn by subject
    4
    -
    1
    4
         Adverse event, non-fatal
    -
    -
    -
    2
         Other reason
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A 40 mg
    Reporting group description
    		 Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort A 60mg
    Reporting group description
    		 Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort B 40 mg
    Reporting group description
    		 Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort C
    Reporting group description
    		 Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C Total
    Number of subjects
    		 39 2 14 37 92
    Age Categorical
    Units: participants
        < 65 years
    		 21 2 11 17 51
        >= 65 - < 75 years
    		 16 0 3 15 34
        >= 75 years
    		 2 0 0 5 7
    Sex: Female, Male
    Units: participants
        Female
    		 11 0 5 2 18
        Male
    		 28 2 9 35 74
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 33 2 9 28 72
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 6 0 5 9 20
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 2 3 7
        Not Hispanic or Latino
    		 30 2 7 23 62
        Unknown or Not Reported
    		 7 0 5 11 23

    End points

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    End points reporting groups
    Reporting group title
    Cohort A 40 mg
    Reporting group description
    		 Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort A 60mg
    Reporting group description
    		 Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort B 40 mg
    Reporting group description
    		 Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort C
    Reporting group description
    		 Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Primary: Overall Response Rate

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    End point title
    		 Overall Response Rate [1]
    End point description
    Overall response rate was defined as the percentage of participants in the treated population who had confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Primary
    End point timeframe
    Every 6 weeks post Cycle 1 (each cycle is of 28 days) Day 1 for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participants (up to approximately 33 months)
    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: Not planned as per study design
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: percentage of participants
        number (confidence interval 95%)
    10.3 (2.9 to 24.2)
    0 (0.0 to 84.2)
    0 (0.0 to 23.2)
    8.6 (1.8 to 23.1)
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

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    End point title
    		 Number of Participants with Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    End point description
    An Adverse Event (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. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 1=mild, Grade 2=Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
        Grade 1
    0
    0
    2
    1
        Grade 2
    14
    0
    2
    4
        Grade 3
    7
    0
    3
    20
        Grade 4
    8
    2
    2
    3
        Grade 5
    10
    0
    5
    6
        Missing
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Laboratory Results with CTCAE Toxicity Grade >=3 for Hematology Parameters

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    End point title
    		 Number of Participants with Laboratory Results with CTCAE Toxicity Grade >=3 for Hematology Parameters
    End point description
    Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (each cycle is of 28 days)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
        Cycle 1 Hemoglobin
    3
    0
    1
    3
        Cycle 1 Leukocytes
    1
    0
    0
    0
        Cycle 1 Lymphocytes
    5
    0
    3
    3
        Cycle 1 Neutrophils
    1
    1
    0
    0
        Cycle 1 Platelets
    3
    2
    1
    0
        Cycle 2 Hemoglobin
    1
    0
    0
    1
        Cycle 2 Lymphocytes
    3
    0
    0
    2
        Cycle 2 Platelets
    5
    0
    0
    1
        Cycle 3 Lymphocytes
    1
    0
    1
    3
        Cycle 3 Platelets
    1
    0
    0
    0
        Cycle 4 Lymphocytes
    1
    0
    0
    1
        Cycle 5 Hemoglobin
    1
    0
    0
    0
        Cycle 5 Lymphocytes
    2
    0
    0
    1
        Cycle 6 Lymphocytes
    1
    0
    0
    1
        Cycle 6 Platelets
    1
    0
    0
    0
        Cycle 7 Lymphocytes
    0
    0
    0
    1
        Cycle 8 Lymphocytes
    0
    0
    0
    1
        Cycle 8 Platelets
    1
    0
    0
    0
        Cycle 9 Lymphocytes
    0
    0
    0
    1
        Cycle 9 Platelets
    1
    0
    0
    0
        Cycle 10 Lymphocytes
    0
    0
    0
    1
        Cycle 10 Platelets
    1
    0
    0
    0
        Cycle 11 Lymphocytes
    0
    0
    0
    1
        Cycle 12 Hemoglobin
    1
    0
    0
    0
        Cycle 14 Platelets
    1
    0
    0
    0
        Cycle 18 Neutrophils
    0
    0
    0
    1
        Cycle 18 Platelets
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Laboratory Results with CTCAE Toxicity Grade >=3 for Chemistry Parameters

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    End point title
    		 Number of Participants with Laboratory Results with CTCAE Toxicity Grade >=3 for Chemistry Parameters
    End point description
    Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (Each cycle is of 28 days)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
        Cycle 1 Alanine Aminotransferase
    0
    0
    2
    0
        Cycle 1 Albumin
    0
    0
    0
    1
        Cycle 1 Alkaline Phosphatase
    0
    0
    0
    1
        Cycle 1 Aspartate Aminotransferase
    0
    0
    1
    1
        Cycle 1 Bilirubin
    1
    0
    0
    1
        Cycle 1 Direct Bilirubin
    1
    0
    2
    1
        Cycle 1 Sodium
    3
    1
    1
    1
        Cycle 2 Alanine Aminotransferase
    1
    0
    1
    0
        Cycle 2 Alkaline Phosphatase
    0
    0
    1
    0
        Cycle 2 Aspartate Aminotransferase
    1
    0
    1
    0
        Cycle 2 Direct Bilirubin
    1
    0
    1
    0
        Cycle 2 Glucose
    0
    0
    0
    1
        Cycle 2 Sodium
    1
    1
    0
    1
        Cycle 3 Calcium
    0
    0
    0
    1
        Cycle 3 Direct Bilirubin
    0
    0
    1
    0
        Cycle 3 Glucose
    0
    0
    0
    1
        Cycle 3 Potassium
    0
    0
    1
    0
        Cycle 4 Direct Bilirubin
    0
    0
    1
    0
        Cycle 4 Sodium
    1
    0
    0
    0
        Cycle 5 Direct Bilirubin
    0
    0
    1
    0
        Cycle 6 Calcium
    1
    0
    0
    0
        Cycle 6 Direct Bilirubin
    0
    0
    1
    0
        Cycle 6 Sodium
    0
    0
    0
    1
        Cycle 7 Direct Bilirubin
    0
    0
    1
    0
        Cycle 8 Direct Bilirubin
    0
    0
    1
    0
        Cycle 9 Direct Bilirubin
    0
    0
    1
    0
        Cycle 9 Glucose
    0
    0
    0
    1
        Cycle 10 Direct Bilirubin
    0
    0
    1
    0
        Cycle 11 Direct Bilirubin
    0
    0
    1
    0
        Cycle 14 Direct Bilirubin
    1
    0
    0
    0
        Cycle 14 Sodium
    1
    0
    0
    0
        Cycle 16 Potassium
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants receiving Concomitant Medication

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    End point title
    		 Number of Participants receiving Concomitant Medication
    End point description
    Concomitant medication is defined as medications that were either initiated before the first dose of study drug and continued during the study treatment, or initiated on/after the date of the first dose of study drug and on/before the date of treatment discontinuation. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab
    End point type
    Secondary
    End point timeframe
    From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
    39
    2
    14
    35
    No statistical analyses for this end point

    Secondary: Change from Baseline at end of treatment in Vital Sign - Weight

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    End point title
    		 Change from Baseline at end of treatment in Vital Sign - Weight
    End point description
    Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Up to 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    32
    1 [2]
    10
    21
    Units: kilogram
        arithmetic mean (standard deviation)
    -1.88 ( 5.583 )
    -1.00 ( 99999 )
    -2.58 ( 5.651 )
    -4.20 ( 8.065 )
    Notes
    [2] - 99999 stands for Not Applicable
    No statistical analyses for this end point

    Secondary: Change from Baseline at end of treatment in Vital Sign - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

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    End point title
    		 Change from Baseline at end of treatment in Vital Sign - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
    End point description
    Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Up to 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    31
    1 [3]
    11
    24
    Units: millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        Systolic Blood Pressure
    -8.5 ( 18.35 )
    5.0 ( 99999 )
    4.8 ( 14.82 )
    -11.2 ( 15.19 )
        Diastolic Blood Pressure
    -4.9 ( 10.84 )
    9.0 ( 99999 )
    -3.2 ( 6.60 )
    -3.1 ( 9.89 )
    Notes
    [3] - 99999 stands for Not Applicable.
    No statistical analyses for this end point

    Secondary: Change from Baseline at end of treatment in Vital Sign - Temperature

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    End point title
    		 Change from Baseline at end of treatment in Vital Sign - Temperature
    End point description
    Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Up to 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    31
    1 [4]
    11
    23
    Units: Celsius
        arithmetic mean (standard deviation)
    0.01 ( 0.376 )
    0.20 ( 99999 )
    0.03 ( 0.388 )
    -0.04 ( 0.509 )
    Notes
    [4] - 99999 stands for Not Applicable.
    No statistical analyses for this end point

    Secondary: Change from Baseline at end of treatment in Vital Sign - Pulse Rate

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    End point title
    		 Change from Baseline at end of treatment in Vital Sign - Pulse Rate
    End point description
    Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Up to 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    31
    1 [5]
    10
    24
    Units: beats per minute
        arithmetic mean (standard deviation)
    -1.0 ( 12.37 )
    -8.0 ( 99999 )
    12.0 ( 14.73 )
    0.4 ( 16.58 )
    Notes
    [5] - 99999 stands for Not Applicable.
    No statistical analyses for this end point

    Secondary: Number of Participants with Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status

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    End point title
    		 Number of Participants with Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status
    End point description
    ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Baseline and up to End of Treatment (107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    33
    1
    11
    23
    Units: participants
        Grade 0 to Grade 0
    2
    0
    4
    1
        Grade 0 to Grade 1
    6
    0
    1
    3
        Grade 0 to Grade 2
    1
    0
    0
    2
        Grade 0 to Grade 3
    0
    0
    0
    1
        Grade 0 to Grade 4
    0
    0
    0
    0
        Grade 0 to Grade 5
    0
    0
    0
    0
        Grade 1 to Grade 0
    0
    0
    0
    0
        Grade 1 to Grade 1
    17
    1
    5
    8
        Grade 1 to Grade 2
    7
    0
    0
    5
        Grade 1 to Grade 3
    0
    0
    1
    3
        Grade 1 to Grade 4
    0
    0
    0
    0
        Grade 1 to Grade 5
    0
    0
    0
    0
        Grade 2 to Grade 0
    0
    0
    0
    0
        Grade 2 to Grade 1
    0
    0
    0
    0
        Grade 2 to Grade 2
    0
    0
    0
    0
        Grade 2 to Grade 3
    0
    0
    0
    0
        Grade 2 to Grade 4
    0
    0
    0
    0
        Grade 2 to Grade 5
    0
    0
    0
    0
        Grade 3 to Grade 0
    0
    0
    0
    0
        Grade 3 to Grade 1
    0
    0
    0
    0
        Grade 3 to Grade 2
    0
    0
    0
    0
        Grade 3 to Grade 3
    0
    0
    0
    0
        Grade 3 to Grade 4
    0
    0
    0
    0
        Grade 3 to Grade 5
    0
    0
    0
    0
        Grade 4 to Grade 0
    0
    0
    0
    0
        Grade 4 to Grade 1
    0
    0
    0
    0
        Grade 4 to Grade 2
    0
    0
    0
    0
        Grade 4 to Grade 3
    0
    0
    0
    0
        Grade 4 to Grade 4
    0
    0
    0
    0
        Grade 4 to Grade 5
    0
    0
    0
    0
        Grade 5 to Grade 0
    0
    0
    0
    0
        Grade 5 to Grade 1
    0
    0
    0
    0
        Grade 5 to Grade 2
    0
    0
    0
    0
        Grade 5 to Grade 3
    0
    0
    0
    0
        Grade 5 to Grade 4
    0
    0
    0
    0
        Grade 5 to Grade 5
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Reduction of CC-90011

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events Leading to Dose Reduction of CC-90011
    End point description
    Adverse Event (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. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
    7
    2
    3
    6
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Interruption of CC-90011

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events Leading to Dose Interruption of CC-90011
    End point description
    Adverse Event (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. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
    27
    1
    6
    26
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Interruption of Nivolumab

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events Leading to Dose Interruption of Nivolumab
    End point description
    Adverse Event (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. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: participants
    16
    0
    3
    14
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Duration of Response was defined as the time from the first occurrence of a confirmed documented response to the time of the first documented tumor progression, as determined by Investigator review per RECIST v1.1, or death from any cause, whichever comes first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Treated Population with confirmed Best Response of CR or PR were included in analysis.
    End point type
    Secondary
    End point timeframe
    Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months))
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    4
    0 [6]
    0 [7]
    3
    Units: days
        arithmetic mean (standard deviation)
    645.0 ( 387.05 )
    ( )
    ( )
    326.0 ( 201.14 )
    Notes
    [6] - Only responders are included in analysis
    [7] - Only responders are included in analysis
    No statistical analyses for this end point

    Secondary: Time to response

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    End point title
    		 Time to response
    End point description
    Time to response was defined as the time from the first dose of the study drug to the date of the first confirmed documented response (CR or PR), as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Treated Population with confirmed best response of CR or PR.
    End point type
    Secondary
    End point timeframe
    Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months))
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    4
    0 [8]
    0 [9]
    3
    Units: days
        median (full range (min-max))
    82.0 (38 to 91)
    ( to )
    ( to )
    79.0 (38 to 126)
    Notes
    [8] - Only responders are included in analysis.
    [9] - Only responders are included in analysis.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival

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    End point title
    		 Progression-Free Survival
    End point description
    Progression-Free Survival is the time from first dose of study treatment to the date of the first objectively documented tumor progression as assessed by Investigator review per RECIST v1.1 or death from any cause, whichever occurs first. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months))
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: days
        arithmetic mean (standard deviation)
    126.4 ( 190.29 )
    33.5 ( 7.78 )
    65.6 ( 57.23 )
    184.9 ( 202.20 )
    No statistical analyses for this end point

    Secondary: Time to First Subsequent Therapy

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    End point title
    		 Time to First Subsequent Therapy
    End point description
    Time to First Subsequent Therapy was defined as the time from the first dose of the study drug to the date of the next cancer therapy or death. Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug to the date of next cancer therapy or death due to any cause (up to approximately 33 months)
    End point values
    		 Cohort A 40 mg Cohort A 60mg Cohort B 40 mg Cohort C
    Number of subjects analysed
    39
    2
    14
    35
    Units: days
        arithmetic mean (standard deviation)
    181.3 ( 183.87 )
    60.0 ( 2.83 )
    113.3 ( 111.51 )
    224.1 ( 203.26 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality was collected from randomization till death due to any cause (Up to approximately 33 months). Serious and Non-Serious Adverse Events were collected from first dose till 100 days after the last dose (up to approximately 849 days).
    Adverse event reporting additional description
    All cause mortality was collected for all the enrolled participants. Serious and Non-Serious Adverse Events were collected for all the treated participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cohort A 40mg
    Reporting group description
    		 Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort B 40 mg
    Reporting group description
    		 Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort C
    Reporting group description
    		 Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Reporting group title
    Cohort A 60mg
    Reporting group description
    		 Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.

    Serious adverse events
    		 Cohort A 40mg Cohort B 40 mg Cohort C Cohort A 60mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 39 (51.28%)
    8 / 14 (57.14%)
    25 / 35 (71.43%)
    2 / 2 (100.00%)
         number of deaths (all causes)
    29
    13
    32
    2
         number of deaths resulting from adverse events
    10
    5
    6
    0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 14 (28.57%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 14 (7.14%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    General physical condition abnormal
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cervical cord compression
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    2 / 2 (100.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Immune-mediated nephritis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    4 / 35 (11.43%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A 40mg Cohort B 40 mg Cohort C Cohort A 60mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 39 (100.00%)
    14 / 14 (100.00%)
    33 / 35 (94.29%)
    2 / 2 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    4
    0
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    General disorders and administration site conditions
    Device related thrombosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asthenia
         subjects affected / exposed
    9 / 39 (23.08%)
    5 / 14 (35.71%)
    12 / 35 (34.29%)
    0 / 2 (0.00%)
         occurrences all number
    10
    6
    14
    0
    Fatigue
         subjects affected / exposed
    16 / 39 (41.03%)
    1 / 14 (7.14%)
    4 / 35 (11.43%)
    1 / 2 (50.00%)
         occurrences all number
    19
    1
    4
    1
    Unevaluable event
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    1
    Swelling
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 14 (28.57%)
    9 / 35 (25.71%)
    0 / 2 (0.00%)
         occurrences all number
    1
    4
    9
    0
    Oedema peripheral
         subjects affected / exposed
    4 / 39 (10.26%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Generalised oedema
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gait disturbance
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Immune system disorders
    Contrast media reaction
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Cough
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 14 (21.43%)
    9 / 35 (25.71%)
    0 / 2 (0.00%)
         occurrences all number
    2
    4
    11
    0
    Dyspnoea
         subjects affected / exposed
    6 / 39 (15.38%)
    3 / 14 (21.43%)
    9 / 35 (25.71%)
    0 / 2 (0.00%)
         occurrences all number
    9
    3
    11
    0
    Epistaxis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Haemoptysis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    4 / 35 (11.43%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    7
    0
    Hypoxia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Hallucination
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood potassium decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    4
    0
    Blood creatinine increased
         subjects affected / exposed
    7 / 39 (17.95%)
    1 / 14 (7.14%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    10
    1
    3
    0
    Blood cholesterol increased
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    10
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    3
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    9 / 39 (23.08%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
    1 / 2 (50.00%)
         occurrences all number
    11
    2
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 39 (17.95%)
    2 / 14 (14.29%)
    3 / 35 (8.57%)
    1 / 2 (50.00%)
         occurrences all number
    7
    4
    3
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Headache
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 14 (14.29%)
    4 / 35 (11.43%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    6
    0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    5 / 39 (12.82%)
    0 / 14 (0.00%)
    4 / 35 (11.43%)
    0 / 2 (0.00%)
         occurrences all number
    6
    0
    7
    0
    Neutropenia
         subjects affected / exposed
    10 / 39 (25.64%)
    2 / 14 (14.29%)
    3 / 35 (8.57%)
    1 / 2 (50.00%)
         occurrences all number
    22
    2
    4
    1
    Thrombocytopenia
         subjects affected / exposed
    25 / 39 (64.10%)
    5 / 14 (35.71%)
    13 / 35 (37.14%)
    1 / 2 (50.00%)
         occurrences all number
    60
    7
    32
    2
    Anaemia
         subjects affected / exposed
    21 / 39 (53.85%)
    8 / 14 (57.14%)
    16 / 35 (45.71%)
    1 / 2 (50.00%)
         occurrences all number
    37
    9
    22
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 14 (14.29%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    4
    2
    4
    0
    Haematochezia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Dyspepsia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    8 / 39 (20.51%)
    0 / 14 (0.00%)
    5 / 35 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    13
    0
    5
    0
    Constipation
         subjects affected / exposed
    6 / 39 (15.38%)
    2 / 14 (14.29%)
    5 / 35 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    6
    3
    6
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Abdominal pain
         subjects affected / exposed
    6 / 39 (15.38%)
    1 / 14 (7.14%)
    4 / 35 (11.43%)
    0 / 2 (0.00%)
         occurrences all number
    6
    1
    4
    0
    Oesophagitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 14 (14.29%)
    5 / 35 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    5
    0
    Stomatitis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Hepatic cytolysis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 14 (14.29%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Alopecia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    5 / 39 (12.82%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    1
    0
    0
    Pruritus
         subjects affected / exposed
    5 / 39 (12.82%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    8
    0
    2
    0
    Petechiae
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal failure
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    6 / 39 (15.38%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    0
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    4 / 35 (11.43%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    4
    0
    Bone pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    4
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 14 (0.00%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Neck pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    1 / 2 (50.00%)
         occurrences all number
    1
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    4 / 39 (10.26%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    1 / 2 (50.00%)
         occurrences all number
    4
    0
    1
    1
    Sacral pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    8 / 39 (20.51%)
    2 / 14 (14.29%)
    6 / 35 (17.14%)
    0 / 2 (0.00%)
         occurrences all number
    9
    2
    8
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Implant site infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 14 (14.29%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    4
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    COVID-19
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    6 / 35 (17.14%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    6
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    12 / 39 (30.77%)
    3 / 14 (21.43%)
    10 / 35 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    14
    3
    11
    0
    Hypercholesterolaemia
         subjects affected / exposed
    4 / 39 (10.26%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 2 (0.00%)
         occurrences all number
    6
    1
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 14 (7.14%)
    3 / 35 (8.57%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    3
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 14 (7.14%)
    2 / 35 (5.71%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    2
    0
    Hypochloraemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 14 (14.29%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    4 / 39 (10.26%)
    4 / 14 (28.57%)
    4 / 35 (11.43%)
    1 / 2 (50.00%)
         occurrences all number
    11
    6
    6
    2
    Hypophosphataemia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Sep 2020
    The primary purpose of this protocol amendment is to address the 2 serious adverse events (SAEs) reported in the first two subjects treated in Study CC-90011-ST-002, and the resulting implementation to reduce the starting dose of CC-90011 to 40 mg. Implementation of this dose reduction was communicated to all participating sites through an administrative letter on 18 Aug 2020. This dose reduction is consistent with Protocol CC-90011-ST-002 language in Section 7.3.2 and the 2 SAEs of Grade 4 thrombocytopenia are consistent with the known safety profile of CC-90011.
    02 Mar 2021
    The primary purpose of this protocol amendment is to include a risk benefit assessment and additional language for severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2)/coronavirus-19 (COVID-19), as well as to update nivolumab guidance for male contraception and update adverse event management algorithms based on the nivolumab Investigator’s Brochure (IB) version 19 addendum 01 and to extend pharmacokinetics and immunogenicity collection to all cohorts.
    30 Apr 2022
    This Protocol Amendment is to reduce the duration of survival follow-up period. As of this amendment, 92 patients have been enrolled across the 3 cohorts, with 41 patientsin Cohort A (4 confirmed responses), 15 patients in Cohort B (0 confirmed responses), and 36 patients in Cohort C (2 confirmed responses).With thelimited number of enrolled patients, overall survival (OS) may not provide meaningful interpretative data. As a result, OS is being moved to an exploratory objective and endpoint. The survival follow-up period is being modifiedby removing the up to 2-year duration and adding in that survival follow-up will stop after the 100-day safety follow-up visit of the last subject on study treatment.

    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.
    None reported
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    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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