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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) plus Epacadostat (INCB024360) Versus Pembrolizumab plus Placebo as First-Line Treatment in Patients with Metastatic Non- Small Cell Lung Cancer Expressing High Levels of PD-L1

    Summary
    EudraCT number
    		 2017-001841-28
    Trial protocol
    		 GB   DK   EE   ES   PL   IT  
    Global end of trial date
    09 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2021
    First version publication date
    16 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KEYNOTE-654-05/ECHO-305-05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, +1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, +1 8554633463, medinfo@incyte.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
    09 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
    Protection of trial subjects
    This study was conducted in conformance with applicable country or local requirements regarding ethical committee review, informed consent, and other statutes or regulations regarding the protection of the rights and welfare of human participants in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 29
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Turkey: 14
    Country: Number of subjects enrolled
    Ukraine: 12
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    154
    EEA total number of subjects
    32
    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)
    71
    From 65 to 84 years
    80
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 154 participants were randomized in 1:1 to either combination (Pembrolizumab+Epacadostat) and control (Pembrolizumab+Placebo) groups. As of Amendment 05, study design was changed to unblinded, open-label, and single-arm (epacadostat and placebo were removed).

    Pre-assignment
    Screening details
    		 A total of 154 participants were randomized and 152 participants received study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pembrolizumab + Epacadostat
    Arm description
    		 Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
    Arm type
    		 Experimental

    Investigational medicinal product name
    epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg twice a day

    Investigational medicinal product name
    pembroluzimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200mg every 3 weeks

    Arm title
    		 Pembrolizumab + Placebo
    Arm description
    		 Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg twice a day

    Investigational medicinal product name
    pembroluzimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200mg every 3 weeks

    Number of subjects in period 1
    		Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Started
    77
    77
    Completed
    46
    40
    Not completed
    31
    37
         Adverse event, serious fatal
    21
    28
         Physician decision
    7
    6
         Consent withdrawn by subject
    3
    1
         Study terminated by sponsor
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pembrolizumab + Epacadostat
    Reporting group description
    		 Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.

    Reporting group title
    Pembrolizumab + Placebo
    Reporting group description
    		 Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.

    Reporting group values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo Total
    Number of subjects
    		 77 77 154
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 40 31 71
        From 65-84 years
    		 36 44 80
        85 years and over
    		 1 2 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.7 ± 9.5 66.9 ± 10.1 -
    Sex: Female, Male
    Units:
        Female
    		 24 18 42
        Male
    		 53 59 112
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 25 23 48
        White
    		 52 54 106
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic Or Latino
    		 7 4 11
        Not Hispanic Or Latino
    		 66 73 139
        Not Reported
    		 3 0 3
        Unknown
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Pembrolizumab + Epacadostat
    Reporting group description
    		 Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.

    Reporting group title
    Pembrolizumab + Placebo
    Reporting group description
    		 Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.

    Primary: Objective response rate (ORR) of pembrolizumab plus epacadostat versus pembrolizumab plus placebo

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    End point title
    		 Objective response rate (ORR) of pembrolizumab plus epacadostat versus pembrolizumab plus placebo
    End point description
    ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
    End point type
    Primary
    End point timeframe
    Up to approximately 6 months
    End point values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Number of subjects analysed
    77
    77
    Units: percentage of participants
        number (confidence interval 95%)
    32.5 (22.2 to 44.1)
    39.0 (28.0 to 50.8)
    Statistical analysis title
    		 Stratified Miettinen and Nurminen method
    Comparison groups
    Pembrolizumab + Epacadostat v Pembrolizumab + Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8
    Method
    		 Stratified Miettinen and Nurminen method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.5
         upper limit
    		 8.7

    Secondary: Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo

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    End point title
    		 Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
    End point description
    PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Up to approximately 36 months
    End point values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Number of subjects analysed
    77
    77
    Units: months
        median (confidence interval 95%)
    6.7 (4.3 to 8.2)
    6.2 (4.3 to 9.9999)
    No statistical analyses for this end point

    Secondary: Overall survival (OS) of Pembrolizumab + Epacadostat versus pembrolizumab + Placebo

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    End point title
    		 Overall survival (OS) of Pembrolizumab + Epacadostat versus pembrolizumab + Placebo
    End point description
    OS is defined as the time from randomization to death due to any cause.
    End point type
    Secondary
    End point timeframe
    Up to approximately 36 months
    End point values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Number of subjects analysed
    77
    77
    Units: Months
        median (confidence interval 95%)
    9.9999 (0.9999 to 99.999)
    9.9999 (0.999999 to 99.9999)
    No statistical analyses for this end point

    Secondary: Duration of response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo

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    End point title
    		 Duration of response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
    End point description
    DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first.
    End point type
    Secondary
    End point timeframe
    Up to approximately 36 months
    End point values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Number of subjects analysed
    77
    77
    Units: Months
        median (full range (min-max))
    6.2 (1.9 to 6.5)
    6.66666 (1.9 to 8.6)
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events (AEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs)
    End point description
    AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 37 months
    End point values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Number of subjects analysed
    75
    77
    Units: Participants
    72
    72
    No statistical analyses for this end point

    Secondary: Number of Participants Who Discontinued Study Drug due to AEs

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    End point title
    		 Number of Participants Who Discontinued Study Drug due to AEs
    End point description
    AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 37 months
    End point values
    		 Pembrolizumab + Epacadostat Pembrolizumab + Placebo
    Number of subjects analysed
    75
    77
    Units: Participants
    15
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 37 months
    Adverse event reporting additional description
    The All Participants as Treated (APaT) population was used for the safety analysis and consisted of all randomized participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Pembrolizumab + Epacadostat
    Reporting group description
    		 Pembrolizumab + Epacadostat Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Pembrolizumab + Placebo
    Reporting group description
    		 Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.

    Serious adverse events
    		 Pembrolizumab + Epacadostat Total Pembrolizumab + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 75 (48.00%)
    71 / 152 (46.71%)
    35 / 77 (45.45%)
         number of deaths (all causes)
    23
    52
    29
         number of deaths resulting from adverse events
    9
    24
    15
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    High-grade B-cell lymphoma
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    6 / 75 (8.00%)
    14 / 152 (9.21%)
    8 / 77 (10.39%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 11
    0 / 7
    Tumour pseudoprogression
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 152 (1.32%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Peripheral ischaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 152 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 152 (1.32%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 152 (1.32%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    4 / 75 (5.33%)
    6 / 152 (3.95%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 152 (1.32%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Psychiatric disorders
    Fear of death
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Autoimmune myocarditis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 152 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pancreatitis
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudodiverticular disease
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis sclerosing
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative generalised
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 152 (1.32%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pneumonia
         subjects affected / exposed
    6 / 75 (8.00%)
    13 / 152 (8.55%)
    7 / 77 (9.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    Pyelonephritis
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 152 (0.66%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 152 (0.66%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 152 (1.32%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pembrolizumab + Epacadostat Total Pembrolizumab + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 75 (92.00%)
    136 / 152 (89.47%)
    67 / 77 (87.01%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 75 (2.67%)
    6 / 152 (3.95%)
    4 / 77 (5.19%)
         occurrences all number
    2
    6
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 75 (10.67%)
    14 / 152 (9.21%)
    6 / 77 (7.79%)
         occurrences all number
    9
    17
    8
    Chest pain
         subjects affected / exposed
    5 / 75 (6.67%)
    11 / 152 (7.24%)
    6 / 77 (7.79%)
         occurrences all number
    5
    12
    7
    Chills
         subjects affected / exposed
    4 / 75 (5.33%)
    5 / 152 (3.29%)
    1 / 77 (1.30%)
         occurrences all number
    5
    7
    2
    Fatigue
         subjects affected / exposed
    9 / 75 (12.00%)
    25 / 152 (16.45%)
    16 / 77 (20.78%)
         occurrences all number
    11
    32
    21
    Oedema peripheral
         subjects affected / exposed
    4 / 75 (5.33%)
    9 / 152 (5.92%)
    5 / 77 (6.49%)
         occurrences all number
    6
    11
    5
    Pyrexia
         subjects affected / exposed
    7 / 75 (9.33%)
    15 / 152 (9.87%)
    8 / 77 (10.39%)
         occurrences all number
    8
    16
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 75 (9.33%)
    15 / 152 (9.87%)
    8 / 77 (10.39%)
         occurrences all number
    9
    17
    8
    Dyspnoea
         subjects affected / exposed
    10 / 75 (13.33%)
    20 / 152 (13.16%)
    10 / 77 (12.99%)
         occurrences all number
    13
    26
    13
    Haemoptysis
         subjects affected / exposed
    6 / 75 (8.00%)
    13 / 152 (8.55%)
    7 / 77 (9.09%)
         occurrences all number
    6
    13
    7
    Productive cough
         subjects affected / exposed
    4 / 75 (5.33%)
    6 / 152 (3.95%)
    2 / 77 (2.60%)
         occurrences all number
    4
    6
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 75 (8.00%)
    10 / 152 (6.58%)
    4 / 77 (5.19%)
         occurrences all number
    7
    12
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 75 (6.67%)
    10 / 152 (6.58%)
    5 / 77 (6.49%)
         occurrences all number
    5
    13
    8
    Amylase increased
         subjects affected / exposed
    8 / 75 (10.67%)
    12 / 152 (7.89%)
    4 / 77 (5.19%)
         occurrences all number
    9
    17
    8
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 75 (5.33%)
    8 / 152 (5.26%)
    4 / 77 (5.19%)
         occurrences all number
    4
    11
    7
    Blood creatinine increased
         subjects affected / exposed
    4 / 75 (5.33%)
    11 / 152 (7.24%)
    7 / 77 (9.09%)
         occurrences all number
    4
    12
    8
    Lipase increased
         subjects affected / exposed
    9 / 75 (12.00%)
    13 / 152 (8.55%)
    4 / 77 (5.19%)
         occurrences all number
    9
    14
    5
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 75 (1.33%)
    5 / 152 (3.29%)
    4 / 77 (5.19%)
         occurrences all number
    1
    8
    7
    Weight decreased
         subjects affected / exposed
    7 / 75 (9.33%)
    15 / 152 (9.87%)
    8 / 77 (10.39%)
         occurrences all number
    7
    15
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 75 (6.67%)
    11 / 152 (7.24%)
    6 / 77 (7.79%)
         occurrences all number
    5
    11
    6
    Dysgeusia
         subjects affected / exposed
    4 / 75 (5.33%)
    5 / 152 (3.29%)
    1 / 77 (1.30%)
         occurrences all number
    4
    5
    1
    Headache
         subjects affected / exposed
    13 / 75 (17.33%)
    17 / 152 (11.18%)
    4 / 77 (5.19%)
         occurrences all number
    15
    19
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 75 (9.33%)
    17 / 152 (11.18%)
    10 / 77 (12.99%)
         occurrences all number
    8
    20
    12
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    20 / 75 (26.67%)
    38 / 152 (25.00%)
    18 / 77 (23.38%)
         occurrences all number
    23
    44
    21
    Diarrhoea
         subjects affected / exposed
    16 / 75 (21.33%)
    33 / 152 (21.71%)
    17 / 77 (22.08%)
         occurrences all number
    30
    55
    25
    Nausea
         subjects affected / exposed
    14 / 75 (18.67%)
    22 / 152 (14.47%)
    8 / 77 (10.39%)
         occurrences all number
    16
    24
    8
    Vomiting
         subjects affected / exposed
    7 / 75 (9.33%)
    13 / 152 (8.55%)
    6 / 77 (7.79%)
         occurrences all number
    8
    14
    6
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    5 / 75 (6.67%)
    9 / 152 (5.92%)
    4 / 77 (5.19%)
         occurrences all number
    5
    9
    4
    Pruritus
         subjects affected / exposed
    16 / 75 (21.33%)
    32 / 152 (21.05%)
    16 / 77 (20.78%)
         occurrences all number
    21
    43
    22
    Rash
         subjects affected / exposed
    15 / 75 (20.00%)
    26 / 152 (17.11%)
    11 / 77 (14.29%)
         occurrences all number
    22
    38
    16
    Rash maculo-papular
         subjects affected / exposed
    4 / 75 (5.33%)
    11 / 152 (7.24%)
    7 / 77 (9.09%)
         occurrences all number
    5
    13
    8
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    8 / 75 (10.67%)
    14 / 152 (9.21%)
    6 / 77 (7.79%)
         occurrences all number
    8
    14
    6
    Hypothyroidism
         subjects affected / exposed
    10 / 75 (13.33%)
    16 / 152 (10.53%)
    6 / 77 (7.79%)
         occurrences all number
    11
    17
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    17 / 75 (22.67%)
    27 / 152 (17.76%)
    10 / 77 (12.99%)
         occurrences all number
    22
    34
    12
    Back pain
         subjects affected / exposed
    10 / 75 (13.33%)
    18 / 152 (11.84%)
    8 / 77 (10.39%)
         occurrences all number
    13
    24
    11
    Myalgia
         subjects affected / exposed
    2 / 75 (2.67%)
    9 / 152 (5.92%)
    7 / 77 (9.09%)
         occurrences all number
    2
    11
    9
    Pain in extremity
         subjects affected / exposed
    5 / 75 (6.67%)
    9 / 152 (5.92%)
    4 / 77 (5.19%)
         occurrences all number
    6
    10
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 75 (2.67%)
    10 / 152 (6.58%)
    8 / 77 (10.39%)
         occurrences all number
    2
    12
    10
    Oral candidiasis
         subjects affected / exposed
    2 / 75 (2.67%)
    6 / 152 (3.95%)
    4 / 77 (5.19%)
         occurrences all number
    3
    9
    6
    Pneumonia
         subjects affected / exposed
    4 / 75 (5.33%)
    7 / 152 (4.61%)
    3 / 77 (3.90%)
         occurrences all number
    4
    7
    3
    Respiratory tract infection
         subjects affected / exposed
    5 / 75 (6.67%)
    6 / 152 (3.95%)
    1 / 77 (1.30%)
         occurrences all number
    5
    7
    2
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 75 (8.00%)
    14 / 152 (9.21%)
    8 / 77 (10.39%)
         occurrences all number
    6
    14
    8
    Urinary tract infection
         subjects affected / exposed
    4 / 75 (5.33%)
    10 / 152 (6.58%)
    6 / 77 (7.79%)
         occurrences all number
    4
    14
    10
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    17 / 75 (22.67%)
    27 / 152 (17.76%)
    10 / 77 (12.99%)
         occurrences all number
    18
    30
    12
    Hyperglycaemia
         subjects affected / exposed
    6 / 75 (8.00%)
    8 / 152 (5.26%)
    2 / 77 (2.60%)
         occurrences all number
    7
    9
    2
    Hyperkalaemia
         subjects affected / exposed
    2 / 75 (2.67%)
    9 / 152 (5.92%)
    7 / 77 (9.09%)
         occurrences all number
    5
    16
    11
    Hypokalaemia
         subjects affected / exposed
    4 / 75 (5.33%)
    9 / 152 (5.92%)
    5 / 77 (6.49%)
         occurrences all number
    6
    13
    7
    Hyponatraemia
         subjects affected / exposed
    6 / 75 (8.00%)
    7 / 152 (4.61%)
    1 / 77 (1.30%)
         occurrences all number
    8
    9
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2017
    To provide specific dose modification and toxicity management guidelines for myocarditis
    06 Mar 2018
    To align HIV and pregnancy testing with regulatory requirements at German sites.
    05 Apr 2018
    To align with regulatory requirements at French sites to exclude participants on coumarin based anticoagulants and prohibit coumarin based anticoagulant treatment for participants receiving epacadostat. In addition, to provide specific dose modification and toxicity management guidelines for myocarditis
    31 May 2018
    Updated Phase 3 design to Phase 2 design, title of protocol and secondary endpoints.
    04 Mar 2019
    Data from the final analysis of KEYNOTE-654/ECHO-305 (data cutoff: 10-JAN-2019) indicated that the study did not meet the pre-specified endpoint of improvement in objective response rate (ORR) for the combination of pembrolizumab plus epacadostat compared with pembrolizumab plus placebo. Based upon these data from the final analysis, the Sponsor and MSD implemented this Amendment 05 to direct that all epacadostat and placebo administration stop, and to reflect that the study is no longer blinded.

    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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