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    Clinical Trial Results:
    A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined with Nivolumab versus Nivolumab Alone in Subjects with Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

    Summary
    EudraCT number
    		 2016-001402-41
    Trial protocol
    		 DE   HU   GB   BE   ES   IT  
    Global end of trial date
    23 Aug 2019

    Results information
    Results version number
    		 v1
    This version publication date
    03 Sep 2020
    First version publication date
    03 Sep 2020
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-296-2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02864381
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    23 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    United States: 28
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Hungary: 3
    Worldwide total number of subjects
    144
    EEA total number of subjects
    109
    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)
    90
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 01 September 2016. The last study visit occurred on 23 August 2019.

    Pre-assignment
    Screening details
    		 187 participants were screened.

    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
    		 Andecaliximab + Nivolumab
    Arm description
    		 Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Andecaliximab
    Investigational medicinal product code
    Other name
    GS-5745
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    800 mg administered via IV infusion 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
    3 mg/kg administered via IV infusion every 2 weeks

    Arm title
    		 Nivolumab
    Arm description
    		 Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
    Arm type
    		 Active comparator

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

    Number of subjects in period 1
    		Andecaliximab + Nivolumab Nivolumab
    Started
    72
    72
    Completed
    0
    0
    Not completed
    72
    72
         Withdrew Consent
    5
    6
         Reason Unknown
    7
    3
         Death
    58
    61
         Investigator's Discretion
    1
    -
         Protocol Violation
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Andecaliximab + Nivolumab
    Reporting group description
    		 Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).

    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).

    Reporting group values
    		 Andecaliximab + Nivolumab Nivolumab Total
    Number of subjects
    		 72 72 144
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58 ± 12.1 59 ± 11.8 -
    Gender categorical
    Units: Subjects
        Female
    		 23 22 45
        Male
    		 49 50 99
    Race
    Not Permitted=local regulators did not allow collection of race information.
    Units: Subjects
        Asian
    		 1 1 2
        Black
    		 2 0 2
        White
    		 55 61 116
        Not Permitted
    		 12 8 20
        Other
    		 2 2 4
    Ethnicity
    Not Permitted=local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    		 2 3 5
        Not Hispanic or Latino
    		 59 61 120
        Not Permitted
    		 11 8 19

    End points

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    End points reporting groups
    Reporting group title
    Andecaliximab + Nivolumab
    Reporting group description
    		 Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).

    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Intent-to-treat Analysis Set included all participants who were randomized in the study.
    End point type
    Primary
    End point timeframe
    Start of treatment to the time when the last participant is treated for 6 months or discontinued, whichever is earlier
    End point values
    		 Andecaliximab + Nivolumab Nivolumab
    Number of subjects analysed
    72
    72
    Units: percentage of participants
        number (confidence interval 95%)
    9.7 (4.0 to 19.0)
    6.9 (2.3 to 15.5)
    Statistical analysis title
    		 Andecaliximab+Nivolumab vs Nivolumab
    Comparison groups
    Andecaliximab + Nivolumab v Nivolumab
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 6.1
    Notes
    [1] - P-value is derived from Cochran-Mantel-Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status. Odds ratio is derived from CMH test stratified by PD-L1 stratus, the Nivolumab alone arm serves as the reference.

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS was defined as the interval in months from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause. The first definitive progressive disease (PD) was defined as the first radiation therapy, the first clinical PD, and the first confirmed imaging PD, whichever came first. Participants without PD or death and participants with PD after starting new anti-cancer therapy are censored at the last tumor assessment date. Participants in the Intent-to-treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
    End point values
    		 Andecaliximab + Nivolumab Nivolumab
    Number of subjects analysed
    72
    72
    Units: months
        median (confidence interval 95%)
    1.840 (1.807 to 2.004)
    1.856 (1.741 to 1.906)
    Statistical analysis title
    		 Andecaliximab+Nivolumab vs Nivolumab
    Comparison groups
    Andecaliximab + Nivolumab v Nivolumab
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.306 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.836
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.589
         upper limit
    		 1.189
    Notes
    [2] - P-value is derived from log-rank test stratified by PD-L1 stratification factor status. Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the interval from the date of randomization to death from any cause. 99999=not applicable (NA). Upper 95% Confidence Interval (CI) were not estimable due to the low number of participants with events. Surviving participants are censored at the last date known alive. Participants in the Intent-to-treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months
    End point values
    		 Andecaliximab + Nivolumab Nivolumab
    Number of subjects analysed
    72
    72
    Units: months
        median (confidence interval 95%)
    7.162 (4.797 to 99999)
    5.881 (3.483 to 10.908)
    Statistical analysis title
    		 Andecaliximab+Nivolumab vs Nivolumab
    Comparison groups
    Andecaliximab + Nivolumab v Nivolumab
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.312 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.786
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.491
         upper limit
    		 1.257
    Notes
    [3] - P-value is derived from log-rank test stratified by PD-L1 stratification factor status. Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the interval from the date of the first response (complete or partial response) was achieved to the earlier of the first documentation of definitive disease progression or death from any cause. 99999=NA. Median and Upper 95% CI were not estimable due to the low number of participants with events. Participants in the Intent-to-treat Analysis Set who achieved CR or PR were analyzed.
    End point type
    Secondary
    End point timeframe
    Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
    End point values
    		 Andecaliximab + Nivolumab Nivolumab
    Number of subjects analysed
    7
    5
    Units: months
        median (confidence interval 95%)
    99999 (1.807 to 99999)
    99999 (2.037 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participants administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events that are defined as AEs with onset dates on or after the first dose of andecaliximab/nivolumab and up to 30 days after permanent discontinuation of andecaliximab or 5 months after permanent discontinuation of nivolumab, or led to premature discontinuation of andecaliximab or nivolumab. The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
    End point values
    		 Andecaliximab + Nivolumab Nivolumab
    Number of subjects analysed
    71
    70
    Units: percentage of participants
        number (not applicable)
    98.6
    97.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Experienced Treatment-emergent Laboratory Abnormalities

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    End point title
    		 Percentage of Participants who Experienced Treatment-emergent Laboratory Abnormalities
    End point description
    Treatment-emergent (Chemistry, Hematology, Coagulation, and Urinalysis) laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of andecaliximab plus 30 days or nivolumab plus 5 months. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment-emergent. Percentage of participants with any postbaseline Grade 1 or higher laboratory abnormality is reported. Participants in the Safety Analysis Set with available data were analyzed. aPTT = activated partial thromboplastin time, INR = international normalized ratio.
    End point type
    Secondary
    End point timeframe
    Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
    End point values
    		 Andecaliximab + Nivolumab Nivolumab
    Number of subjects analysed
    71
    70
    Units: percentage of participants
    number (not applicable)
        Alanine Aminotransferase Increased (n=70, 70)
    20.0
    27.1
        Alkaline Phosphatase Increased
    45.1
    40.0
        Aspartate Aminotransferase Increased (n=70, 70)
    30.0
    28.6
        Blood Bilirubin Increased
    8.5
    11.4
        Chronic Kidney Disease
    16.9
    25.7
        Creatinine Increased
    1.4
    7.1
        Hyperglycemia
    22.5
    18.6
        Hyperkalemia (n=70, 70)
    7.1
    5.7
        Hypermagnesemia
    2.8
    1.4
        Hypoalbuminemia
    35.2
    38.6
        Hypoglycemia
    11.3
    4.3
        Hypokalemia (n=70, 70)
    10.0
    11.4
        Hypomagnesemia
    5.6
    4.3
        Hyponatremia
    28.2
    40.0
        Hypophosphatemia
    11.3
    8.6
        Lipase Increased
    11.3
    8.6
        Serum Amylase Increased
    9.9
    7.1
        aPTT Prolonged (n=39, 31)
    2.6
    19.4
        INR Increased (n=39, 32)
    2.6
    12.5
        Anemia (n=71, 69)
    53.5
    56.5
        Lymphocytes, Typical Count Decreased (n=71, 69)
    35.2
    27.5
        Lymphocytes, Typical Count Increased (n=71, 69)
    4.2
    0
        Neutrophil Count Decreased (n=71, 69)
    5.6
    5.8
        Platelet Count Decreased (n=71, 69)
    8.5
    5.8
        White Blood Cell Decreased (n=71, 69)
    9.9
    7.2
        Proteinuria (Dipstick) (n=68, 67)
    29.4
    31.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Deaths:Andecaliximab + Nivolumab median follow-up time 28.2 months; Nivolumab median follow-up time 28.4 months; AEs: Andecaliximab: First dose to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose to last dose (maximum: 101 weeks) + 5 months
    Adverse event reporting additional description
    Deaths: The Intent-to Treat Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Andecaliximab + Nivolumab
    Reporting group description
    		 Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).

    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab 3 mg/kg administered via IV infsion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).

    Serious adverse events
    		 Andecaliximab + Nivolumab Nivolumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 71 (59.15%)
    38 / 70 (54.29%)
         number of deaths (all causes)
    61
    62
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 71 (2.82%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Euthanasia
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    General physical health deterioration
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Complication associated with device
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 71 (2.82%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (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
    Accidental overdose
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular fibrillation
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         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 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         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
    5 / 71 (7.04%)
    4 / 70 (5.71%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal disorder
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 71 (4.23%)
    6 / 70 (8.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 70 (5.71%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 71 (4.23%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 71 (4.23%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    4 / 71 (5.63%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 71 (4.23%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    3 / 70 (4.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    3 / 71 (4.23%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 71 (4.23%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Melaena
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric stenosis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal failure
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypophysitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 71 (1.41%)
    3 / 70 (4.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Sepsis
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
         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
    		 Andecaliximab + Nivolumab Nivolumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 71 (92.96%)
    62 / 70 (88.57%)
    Investigations
    Weight decreased
         subjects affected / exposed
    5 / 71 (7.04%)
    7 / 70 (10.00%)
         occurrences all number
    5
    8
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 70 (5.71%)
         occurrences all number
    4
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 70 (5.71%)
         occurrences all number
    4
    4
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 71 (7.04%)
    2 / 70 (2.86%)
         occurrences all number
    5
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 71 (8.45%)
    8 / 70 (11.43%)
         occurrences all number
    6
    9
    Headache
         subjects affected / exposed
    6 / 71 (8.45%)
    6 / 70 (8.57%)
         occurrences all number
    6
    7
    Paraesthesia
         subjects affected / exposed
    1 / 71 (1.41%)
    4 / 70 (5.71%)
         occurrences all number
    1
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 71 (19.72%)
    14 / 70 (20.00%)
         occurrences all number
    16
    18
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 71 (30.99%)
    25 / 70 (35.71%)
         occurrences all number
    27
    29
    Asthenia
         subjects affected / exposed
    21 / 71 (29.58%)
    12 / 70 (17.14%)
         occurrences all number
    29
    12
    Pyrexia
         subjects affected / exposed
    10 / 71 (14.08%)
    4 / 70 (5.71%)
         occurrences all number
    11
    5
    Oedema peripheral
         subjects affected / exposed
    6 / 71 (8.45%)
    6 / 70 (8.57%)
         occurrences all number
    6
    6
    Chest pain
         subjects affected / exposed
    1 / 71 (1.41%)
    4 / 70 (5.71%)
         occurrences all number
    1
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    27 / 71 (38.03%)
    17 / 70 (24.29%)
         occurrences all number
    34
    20
    Vomiting
         subjects affected / exposed
    22 / 71 (30.99%)
    18 / 70 (25.71%)
         occurrences all number
    30
    21
    Constipation
         subjects affected / exposed
    18 / 71 (25.35%)
    18 / 70 (25.71%)
         occurrences all number
    20
    21
    Abdominal pain
         subjects affected / exposed
    11 / 71 (15.49%)
    16 / 70 (22.86%)
         occurrences all number
    11
    21
    Diarrhoea
         subjects affected / exposed
    14 / 71 (19.72%)
    9 / 70 (12.86%)
         occurrences all number
    18
    23
    Dysphagia
         subjects affected / exposed
    12 / 71 (16.90%)
    8 / 70 (11.43%)
         occurrences all number
    13
    9
    Abdominal pain upper
         subjects affected / exposed
    11 / 71 (15.49%)
    2 / 70 (2.86%)
         occurrences all number
    13
    2
    Ascites
         subjects affected / exposed
    7 / 71 (9.86%)
    4 / 70 (5.71%)
         occurrences all number
    8
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 71 (8.45%)
    2 / 70 (2.86%)
         occurrences all number
    7
    2
    Dry mouth
         subjects affected / exposed
    2 / 71 (2.82%)
    5 / 70 (7.14%)
         occurrences all number
    2
    5
    Dyspepsia
         subjects affected / exposed
    5 / 71 (7.04%)
    2 / 70 (2.86%)
         occurrences all number
    5
    2
    Abdominal distension
         subjects affected / exposed
    4 / 71 (5.63%)
    2 / 70 (2.86%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    10 / 71 (14.08%)
    9 / 70 (12.86%)
         occurrences all number
    10
    10
    Cough
         subjects affected / exposed
    4 / 71 (5.63%)
    8 / 70 (11.43%)
         occurrences all number
    5
    8
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 71 (4.23%)
    6 / 70 (8.57%)
         occurrences all number
    4
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 71 (4.23%)
    9 / 70 (12.86%)
         occurrences all number
    3
    9
    Anxiety
         subjects affected / exposed
    5 / 71 (7.04%)
    2 / 70 (2.86%)
         occurrences all number
    5
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 71 (15.49%)
    5 / 70 (7.14%)
         occurrences all number
    11
    6
    Arthralgia
         subjects affected / exposed
    4 / 71 (5.63%)
    6 / 70 (8.57%)
         occurrences all number
    5
    6
    Myalgia
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 70 (5.71%)
         occurrences all number
    3
    4
    Muscle spasms
         subjects affected / exposed
    0 / 71 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    0
    4
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    7 / 71 (9.86%)
    1 / 70 (1.43%)
         occurrences all number
    7
    1
    Oral candidiasis
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 70 (5.71%)
         occurrences all number
    4
    4
    Nasopharyngitis
         subjects affected / exposed
    4 / 71 (5.63%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    24 / 71 (33.80%)
    20 / 70 (28.57%)
         occurrences all number
    29
    26
    Hypokalaemia
         subjects affected / exposed
    5 / 71 (7.04%)
    7 / 70 (10.00%)
         occurrences all number
    6
    8
    Dehydration
         subjects affected / exposed
    2 / 71 (2.82%)
    5 / 70 (7.14%)
         occurrences all number
    2
    5
    Hyponatraemia
         subjects affected / exposed
    2 / 71 (2.82%)
    5 / 70 (7.14%)
         occurrences all number
    2
    5
    Hyperkalaemia
         subjects affected / exposed
    2 / 71 (2.82%)
    4 / 70 (5.71%)
         occurrences all number
    2
    4
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    4 / 70 (5.71%)
         occurrences all number
    1
    4
    Hypomagnesaemia
         subjects affected / exposed
    4 / 71 (5.63%)
    1 / 70 (1.43%)
         occurrences all number
    5
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jun 2016
    • Modified eligibility tissue requirements for PD-L1 stratification and made a new pretreatment biopsy optional. • Updated chemistry analytes that were tested by the central laboratory. • Clarified urine pregnancy procedures in the schedule of assessments. • Modified eligibility requirements based on central labs. • Clarified dosing information for nivolumab in the Dosage and Administration Section.
    02 Aug 2016
    • Added Thyroid function tests o the schedule of assessments and the body of the protocol to maintain consistency with protocol. • Added an exclusion criterion to exclude participants with history of bone marrow, stem cell, or allogenic organ transplantation.
    16 Jun 2017
    Updated the section regarding Discontinuation Criteria for nivolumab to refer to the local nivolumab Summary of Product Characteristics (SmPC) for dose adjustments, AE management guidance, and discontinuation criteria.

    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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