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    Clinical Trial Results:
    An Open-label Randomized Phase III Trial of BMS-936558 (Nivolumab) versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 017)

    Summary
    EudraCT number
    		 2011-004792-36
    Trial protocol
    		 IE   DE   NL   GB   IT   ES   AT   HU   CZ   NO   PL  
    Global end of trial date
    16 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2022
    First version publication date
    01 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA209-017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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)
    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
    13 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    BMS-936558 (nivolumab) increases OS as compared with docetaxel, in squamous cell NSCLC subjects treated with prior platinum doublet-based chemotherapy.
    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 Oct 2012
    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
    Argentina: 8
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Chile: 8
    Country: Number of subjects enrolled
    Czechia: 5
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Norway: 4
    Country: Number of subjects enrolled
    Peru: 2
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 84
    Worldwide total number of subjects
    272
    EEA total number of subjects
    126
    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)
    152
    From 65 to 84 years
    119
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 272 participants were randomized and 260 received treatment

    Period 1
    Period 1 title
    Randomization
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nivolumab
    Arm description
    		 Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
    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 3 mg/kg solution intravenously every 2 weeks

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab at 480mg every 4 weeks

    Arm title
    		 Docetaxel
    Arm description
    		 Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients may receive nivolumab 3 mg/kg every 2 weeks and/or nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    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 at 480mg every 4 weeks

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion, Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75 mg/m^2 solution intravenously every 3 weeks

    Number of subjects in period 1
    		Nivolumab Docetaxel
    Started
    135
    137
    Completed
    131
    129
    Not completed
    4
    8
         Adverse Event unrelated to study drug
    1
    -
         Participant withdrew consent
    1
    6
         No longer meets study criteria
    2
    2
    Period 2
    Period 2 title
    Transition to Nivolumab
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nivolumab
    Arm description
    		 Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
    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 at 480mg every 4 weeks

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 3 mg/kg solution intravenously every 2 weeks

    Arm title
    		 Docetaxel
    Arm description
    		 Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients may receive nivolumab 3 mg/kg every 2 weeks and/or nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    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 at 480mg every 4 weeks

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion, Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75 mg/m^2 solution intravenously every 3 weeks

    Number of subjects in period 2
    		Nivolumab Docetaxel
    Started
    131
    129
    Subjects transitioned to Nivolumab
    0
    6
    Completed
    0
    0
    Not completed
    131
    129
         Adverse event, serious fatal
    1
    1
         Subject withdrew consent
    5
    5
         Adverse Event unrelated to study drug
    9
    13
         Disease progression
    95
    79
         Study drug toxicity
    10
    13
         Subject request to discontinue study treatment
    6
    4
         Not reported
    -
    3
         Maximum clinical benefit
    1
    9
         Other reasons
    2
    -
         Poor/Non-compliance
    1
    -
         No longer meets study criteria
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients may receive nivolumab 3 mg/kg every 2 weeks and/or nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

    Reporting group values
    		 Nivolumab Docetaxel Total
    Number of subjects
    		 135 137 272
    Age Categorical
    Units: Participants
        < 65 years
    		 79 73 152
        >= 65 AND < 75 years
    		 45 46 91
        >= 75 AND < 85 years
    		 10 18 28
        >= 85 years
    		 1 0 1
        <= 18 years
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.2 ( 8.33 ) 64.4 ( 8.28 ) -
    Sex: Female, Male
    Units:
        Female
    		 24 40 64
        Male
    		 111 97 208
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 5 12
        Not Hispanic or Latino
    		 61 60 121
        Unknown or Not Reported
    		 67 72 139
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 4 2 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 6 2 8
        White
    		 122 130 252
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 3 3 6

    End points

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    End points reporting groups
    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients may receive nivolumab 3 mg/kg every 2 weeks and/or nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients may receive nivolumab 3 mg/kg every 2 weeks and/or nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

    Primary: Overall Survival (OS) Rate in All Randomized Participants

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    End point title
    		 Overall Survival (OS) Rate in All Randomized Participants [1]
    End point description
    The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
    End point type
    Primary
    End point timeframe
    Randomization to 18 months post-randomization, up to June 2015
    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 were planned for this endpoint
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Percent probability of OS
    number (confidence interval 95%)
        6 months
    63.7 (55.0 to 71.2)
    50.7 (42.1 to 58.8)
        12 months
    42.2 (33.8 to 50.4)
    24.3 (17.4 to 31.7)
        18 months
    28.1 (20.8 to 35.8)
    12.5 (7.6 to 18.7)
    No statistical analyses for this end point

    Primary: Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint

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    End point title
    		 Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint [2]
    End point description
    The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
    End point type
    Primary
    End point timeframe
    Randomization until 199 deaths, up to November 2014, approximately 25 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 were planned for this endpoint
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Participants
    86
    113
    No statistical analyses for this end point

    Primary: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint

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    End point title
    		 Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
    End point description
    OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
    End point type
    Primary
    End point timeframe
    Randomization until 199 deaths, up to November 2014, approximately 25 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: months
        median (confidence interval 95%)
    9.23 (7.33 to 13.27)
    6.01 (5.13 to 7.33)
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    Nivolumab v Docetaxel
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 96.85%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 0.81
    Notes
    [3] - Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).

    Secondary: Objective Response Rate (ORR) in All Randomized Participants

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    End point title
    		 Objective Response Rate (ORR) in All Randomized Participants
    End point description
    ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
    End point type
    Secondary
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: percentage of participants
        number (confidence interval 95%)
    20.0 (13.6 to 27.7)
    8.8 (4.6 to 14.8)
    No statistical analyses for this end point

    Secondary: Time To Response (TTR) in Months for All Confirmed Responders

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    End point title
    		 Time To Response (TTR) in Months for All Confirmed Responders
    End point description
    Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
    End point type
    Secondary
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    27
    12
    Units: Months
        median (full range (min-max))
    2.23 (1.6 to 11.8)
    2.09 (1.8 to 9.5)
    No statistical analyses for this end point

    Secondary: Duration of Objective Response (DOR) in Months for All Confirmed Responders

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    End point title
    		 Duration of Objective Response (DOR) in Months for All Confirmed Responders
    End point description
    DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment.
    End point type
    Secondary
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    27
    12
    Units: Months
        median (confidence interval 95%)
    24.51 (9.76 to 69.65)
    8.41 (3.58 to 14.03)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) Time in Months for All Randomized Participants

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    End point title
    		 Progression-Free Survival (PFS) Time in Months for All Randomized Participants
    End point description
    PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
    End point type
    Secondary
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Months
        median (confidence interval 95%)
    3.48 (2.14 to 5.06)
    2.83 (2.10 to 3.52)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12

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    End point title
    		 Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12
    End point description
    Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
    End point type
    Secondary
    End point timeframe
    From randomization up to Week 12
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: percentage of participants
        number (confidence interval 95%)
    18.5 (12.4 to 26.1)
    21.2 (14.7 to 29.0)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

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    End point title
    		 Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
    End point description
    OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method.
    End point type
    Secondary
    End point timeframe
    From the date of randomization to the date of death from any cause, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Months
    median (confidence interval 95%)
        PD-L1 expression >= 5%
    9.95 (5.82 to 16.69)
    6.37 (4.50 to 9.03)
        PD-L1 expression < 5%
    8.54 (5.49 to 12.62)
    6.14 (5.13 to 8.28)
        PD-L1 not quantifiable at baseline
    9.41 (7.10 to 25.20)
    5.06 (3.02 to 6.11)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants

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    End point title
    		 Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
    End point description
    ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
    End point type
    Secondary
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Percentage of participants
    number (confidence interval 95%)
        PD-L1 expression >= 5%
    21.4 (10.3 to 36.8)
    7.7 (1.6 to 20.9)
        PD-L1 expression < 5%
    14.7 (7.6 to 24.7)
    11.6 (5.1 to 21.6)
        PD-L1 not quantifiable at baseline
    38.9 (17.3 to 64.3)
    3.4 (0.1 to 17.8)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

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    End point title
    		 Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
    End point description
    PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy.
    End point type
    Secondary
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Months
    median (confidence interval 95%)
        PD-L1 expression >= 5%
    5.06 (2.10 to 7.56)
    3.06 (1.94 to 4.63)
        PD-L1 expression < 5%
    2.23 (1.94 to 4.73)
    2.92 (2.07 to 3.58)
        PD-L1 not quantifiable at baseline
    5.39 (2.10 to 10.45)
    2.23 (2.04 to 4.40)
    No statistical analyses for this end point

    Secondary: Progression Free Survival Rate (PFSR)

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    End point title
    		 Progression Free Survival Rate (PFSR)
    End point description
    PFSR was defined as the percentage of participants who did not experience disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy. "999"=N/A
    End point type
    Secondary
    End point timeframe
    From randomization to specified timepoints, up to 84 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Percentage of participants
    number (confidence interval 95%)
        6 months
    38.4 (30.0 to 46.8)
    22.6 (15.7 to 30.2)
        12 months
    21.0 (14.3 to 28.6)
    7.2 (3.4 to 12.8)
        18 months
    15.87 (9.9 to 22.8)
    1.8 (0.4 to 5.7)
        24 months
    14.8 (9.1 to 21.8)
    999 (999 to 999)
        36 months
    11.0 (6.1 to 17.5)
    999 (999 to 999)
        48 months
    8.9 (4.5 to 15.1)
    999 (999 to 999)
        60 months
    8.9 (4.5 to 15.1)
    999 (999 to 999)
        72 months
    7.6 (3.5 to 13.7)
    999 (999 to 999)
        84 months
    6.1 (2.4 to 12.2)
    999 (999 to 999)
    No statistical analyses for this end point

    Post-hoc: Overall Survival (OS) Rate in All Randomized Participants at Study Completion

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    End point title
    		 Overall Survival (OS) Rate in All Randomized Participants at Study Completion
    End point description
    The overall survival rate is the probability that a participant will be alive at the specified timepoints following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates. "999"=N/A
    End point type
    Post-hoc
    End point timeframe
    From the date of randomization up to the specified timepoints, up to 84 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Months
    median (confidence interval 95%)
        6 months
    63.7 (55.0 to 71.2)
    50.4 (41.7 to 58.4)
        12 months
    42.2 (33.8 to 50.4)
    24.1 (17.3 to 31.5)
        18 months
    28.1 (20.8 to 35.9)
    12.4 (7.6 to 18.5)
        24 months
    23.0 (16.3 to 30.3)
    8.0 (4.3 to 13.3)
        36 months
    15.6 (10.0 to 22.2)
    5.8 (2.7 to 10.6)
        48 months
    13.1 (8.1 to 19.5)
    4.4 (1.8 to 8.8)
        60 months
    12.3 (7.4 to 18.5)
    3.6 (1.4 to 7.8)
        72 months
    11.4 (6.7 to 17.5)
    2.7 (0.8 to 6.7)
        84 months
    9.6 (5.3 to 15.5)
    0.0 (-999 to 999)
    No statistical analyses for this end point

    Post-hoc: Overall Survival (OS) Time in Months for All Randomized Participants at Study Completion

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    End point title
    		 Overall Survival (OS) Time in Months for All Randomized Participants at Study Completion
    End point description
    OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred at the end of the study.
    End point type
    Post-hoc
    End point timeframe
    From the date of randomization up to the final database lock, up to approximately 108 months
    End point values
    		 Nivolumab Docetaxel
    Number of subjects analysed
    135
    137
    Units: Months
        median (confidence interval 95%)
    9.23 (7.33 to 12.62)
    6.01 (5.13 to 7.33)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Assessed from date of first dose to 100 days following date of last dose (up to approximately 108 months).
    Adverse event reporting additional description
    All-cause mortality, serious adverse events, and adverse events were reported for all treated participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    MedDRA24.0
    Reporting groups
    Reporting group title
    DOCETAXEL
    Reporting group description
    		 Docetaxel 75mg/m^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends. Eligible patients may receive nivolumab 3 mg/kg every 2 weeks and/or nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

    Reporting group title
    NIVOLUMAB
    Reporting group description
    		 Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

    Serious adverse events
    		 DOCETAXEL NIVOLUMAB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    93 / 129 (72.09%)
    86 / 131 (65.65%)
         number of deaths (all causes)
    127
    117
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    36 / 129 (27.91%)
    40 / 131 (30.53%)
         occurrences causally related to treatment / all
    0 / 36
    0 / 43
         deaths causally related to treatment / all
    0 / 33
    0 / 36
    Metastases to central nervous system
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Arterial haemorrhage
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 129 (0.78%)
    5 / 131 (3.82%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    2 / 129 (1.55%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Fatigue
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oedema peripheral
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (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
    4 / 129 (3.10%)
    4 / 131 (3.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 129 (1.55%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cough
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    4 / 129 (3.10%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    1 / 4
    0 / 1
    Pneumonitis
         subjects affected / exposed
    0 / 129 (0.00%)
    3 / 131 (2.29%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 129 (0.78%)
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    5 / 129 (3.88%)
    3 / 131 (2.29%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Pulmonary embolism
         subjects affected / exposed
    2 / 129 (1.55%)
    3 / 131 (2.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation oesophagitis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 129 (1.55%)
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Atrial thrombosis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 129 (3.10%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    3 / 129 (2.33%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myasthenic syndrome
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         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
    Anaemia
         subjects affected / exposed
    0 / 129 (0.00%)
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    13 / 129 (10.08%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    14 / 14
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 129 (2.33%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile bone marrow aplasia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelosuppression
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 129 (2.33%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 129 (2.33%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 129 (0.00%)
    3 / 131 (2.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis ulcerative
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Immune-mediated hepatitis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal insufficiency
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Enterocolitis infectious
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    18 / 129 (13.95%)
    15 / 131 (11.45%)
         occurrences causally related to treatment / all
    3 / 21
    0 / 16
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 129 (0.00%)
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic infection
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 129 (0.78%)
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 129 (1.55%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 129 (3.10%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    1 / 129 (0.78%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 129 (2.33%)
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 129 (0.78%)
    4 / 131 (3.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyperglycaemia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DOCETAXEL NIVOLUMAB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 129 (94.57%)
    119 / 131 (90.84%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 129 (3.88%)
    7 / 131 (5.34%)
         occurrences all number
    6
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    27 / 129 (20.93%)
    27 / 131 (20.61%)
         occurrences all number
    33
    40
    Chest pain
         subjects affected / exposed
    11 / 129 (8.53%)
    6 / 131 (4.58%)
         occurrences all number
    11
    6
    Chills
         subjects affected / exposed
    3 / 129 (2.33%)
    9 / 131 (6.87%)
         occurrences all number
    3
    11
    Mucosal inflammation
         subjects affected / exposed
    13 / 129 (10.08%)
    3 / 131 (2.29%)
         occurrences all number
    16
    3
    Fatigue
         subjects affected / exposed
    52 / 129 (40.31%)
    42 / 131 (32.06%)
         occurrences all number
    65
    58
    Asthenia
         subjects affected / exposed
    27 / 129 (20.93%)
    26 / 131 (19.85%)
         occurrences all number
    34
    30
    Oedema peripheral
         subjects affected / exposed
    16 / 129 (12.40%)
    11 / 131 (8.40%)
         occurrences all number
    18
    14
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 129 (1.55%)
    8 / 131 (6.11%)
         occurrences all number
    2
    10
    Pain
         subjects affected / exposed
    6 / 129 (4.65%)
    8 / 131 (6.11%)
         occurrences all number
    7
    9
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    39 / 129 (30.23%)
    47 / 131 (35.88%)
         occurrences all number
    43
    55
    Haemoptysis
         subjects affected / exposed
    11 / 129 (8.53%)
    9 / 131 (6.87%)
         occurrences all number
    13
    11
    Cough
         subjects affected / exposed
    26 / 129 (20.16%)
    45 / 131 (34.35%)
         occurrences all number
    26
    60
    Dysphonia
         subjects affected / exposed
    1 / 129 (0.78%)
    11 / 131 (8.40%)
         occurrences all number
    1
    11
    Productive cough
         subjects affected / exposed
    5 / 129 (3.88%)
    7 / 131 (5.34%)
         occurrences all number
    5
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 129 (5.43%)
    9 / 131 (6.87%)
         occurrences all number
    8
    10
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    8 / 129 (6.20%)
    0 / 131 (0.00%)
         occurrences all number
    8
    0
    Weight decreased
         subjects affected / exposed
    9 / 129 (6.98%)
    13 / 131 (9.92%)
         occurrences all number
    11
    14
    White blood cell count decreased
         subjects affected / exposed
    8 / 129 (6.20%)
    0 / 131 (0.00%)
         occurrences all number
    9
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 129 (2.33%)
    8 / 131 (6.11%)
         occurrences all number
    3
    11
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    9 / 129 (6.98%)
    5 / 131 (3.82%)
         occurrences all number
    10
    6
    Headache
         subjects affected / exposed
    10 / 129 (7.75%)
    19 / 131 (14.50%)
         occurrences all number
    11
    22
    Dizziness
         subjects affected / exposed
    13 / 129 (10.08%)
    13 / 131 (9.92%)
         occurrences all number
    14
    17
    Neuropathy peripheral
         subjects affected / exposed
    14 / 129 (10.85%)
    4 / 131 (3.05%)
         occurrences all number
    14
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    43 / 129 (33.33%)
    27 / 131 (20.61%)
         occurrences all number
    55
    37
    Leukopenia
         subjects affected / exposed
    11 / 129 (8.53%)
    3 / 131 (2.29%)
         occurrences all number
    17
    5
    Neutropenia
         subjects affected / exposed
    43 / 129 (33.33%)
    4 / 131 (3.05%)
         occurrences all number
    57
    6
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    20 / 129 (15.50%)
    14 / 131 (10.69%)
         occurrences all number
    26
    18
    Diarrhoea
         subjects affected / exposed
    34 / 129 (26.36%)
    24 / 131 (18.32%)
         occurrences all number
    37
    42
    Nausea
         subjects affected / exposed
    35 / 129 (27.13%)
    25 / 131 (19.08%)
         occurrences all number
    43
    34
    Abdominal pain
         subjects affected / exposed
    10 / 129 (7.75%)
    8 / 131 (6.11%)
         occurrences all number
    11
    10
    Constipation
         subjects affected / exposed
    19 / 129 (14.73%)
    18 / 131 (13.74%)
         occurrences all number
    20
    18
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 129 (3.10%)
    11 / 131 (8.40%)
         occurrences all number
    6
    11
    Rash
         subjects affected / exposed
    12 / 129 (9.30%)
    12 / 131 (9.16%)
         occurrences all number
    13
    13
    Alopecia
         subjects affected / exposed
    30 / 129 (23.26%)
    2 / 131 (1.53%)
         occurrences all number
    30
    2
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 129 (0.00%)
    7 / 131 (5.34%)
         occurrences all number
    0
    8
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    7 / 129 (5.43%)
    3 / 131 (2.29%)
         occurrences all number
    8
    4
    Musculoskeletal chest pain
         subjects affected / exposed
    4 / 129 (3.10%)
    7 / 131 (5.34%)
         occurrences all number
    4
    9
    Myalgia
         subjects affected / exposed
    15 / 129 (11.63%)
    3 / 131 (2.29%)
         occurrences all number
    21
    4
    Back pain
         subjects affected / exposed
    12 / 129 (9.30%)
    14 / 131 (10.69%)
         occurrences all number
    14
    18
    Arthralgia
         subjects affected / exposed
    19 / 129 (14.73%)
    17 / 131 (12.98%)
         occurrences all number
    24
    24
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 129 (3.88%)
    8 / 131 (6.11%)
         occurrences all number
    5
    12
    Bronchitis
         subjects affected / exposed
    4 / 129 (3.10%)
    15 / 131 (11.45%)
         occurrences all number
    4
    18
    Pneumonia
         subjects affected / exposed
    7 / 129 (5.43%)
    6 / 131 (4.58%)
         occurrences all number
    7
    6
    Urinary tract infection
         subjects affected / exposed
    7 / 129 (5.43%)
    4 / 131 (3.05%)
         occurrences all number
    12
    4
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    3 / 129 (2.33%)
    7 / 131 (5.34%)
         occurrences all number
    3
    10
    Hypomagnesaemia
         subjects affected / exposed
    5 / 129 (3.88%)
    8 / 131 (6.11%)
         occurrences all number
    5
    9
    Decreased appetite
         subjects affected / exposed
    43 / 129 (33.33%)
    35 / 131 (26.72%)
         occurrences all number
    54
    38
    Hyperglycaemia
         subjects affected / exposed
    10 / 129 (7.75%)
    9 / 131 (6.87%)
         occurrences all number
    10
    11
    Hypokalaemia
         subjects affected / exposed
    4 / 129 (3.10%)
    7 / 131 (5.34%)
         occurrences all number
    5
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    Updated to include language on contraception and adverse pregnancy outcomes
    29 May 2013
    Added "CheckMate 017, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation" to the protocol title; replaced the BMS number with nivolumab throughout the document; updated table naming convention; 2nd and 4th secondary objectives updated; added clarifying language on premedication for docetaxel; added nephrotoxicity to the safety information; clarified exclusion criteria; updated peripheral blood markers
    25 Apr 2014
    Modification to overall survival analysis; modification to move objective response rate from co-primary endpoint to secondary endpoint
    26 Jan 2015
    Added provision for eligible subjects randomized to docetaxel arm to receive subsequent nivolumab treatment as part of a nivolumab extension phase; modifications to the Time and Events Schedule
    15 Sep 2016
    Added option for the nivolumand treatement group to switch to a flat dose of nivolumab at 480mg every 4 weeks; updated to allow 30 minute nivolumab infusions; updated contraception requirements

    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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