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    Clinical Trial Results:
    An Open-Label, Randomized, Phase 2, Umbrella Study of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy (Optimus)

    Summary
    EudraCT number
    2020-002244-23
    Trial protocol
    FR   IT  
    Global end of trial date
    29 Jan 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Feb 2025
    First version publication date
    09 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 24360-901
    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, 1 855-463-3463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 855-463-3463, 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
    29 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was conducted to determine biologic response in participants who had muscle-invasive urothelial carcinoma of the bladder and were cisplatin ineligible or refused cisplatin therapy and were awaiting radical cystectomy.
    Protection of trial subjects
    This study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was being conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Jan 2022
    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
    France: 5
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    30
    EEA total number of subjects
    21
    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)
    6
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants were enrolled at 2 study centers in the United States, 2 study centers in Italy, and 1 study center in France.

    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
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W
    Arm description
    Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    retifanlimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/milliliter (mL) liquid formulation administered intravenously over 30 minutes (+ 15 minutes) on Day 1 of each 28-day cycle

    Investigational medicinal product name
    epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For the 600 mg BID dose, two 300-mg tablets BID. For the 400 mg BID dose reduction, one 300-mg and one 100-mg tablet. Both dose levels were administered without regard to food. Epacadostat was administered daily up to and including the day of surgery.

    Arm title
    Retifanlimab 500 mg Q4W
    Arm description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    retifanlimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/mL liquid formulation administered intravenously over 30 minutes (+ 15 minutes) on Day 1 of each 28-day cycle

    Arm title
    Epacadostat 600 mg BID
    Arm description
    Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
    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
    For the 600 mg BID dose, two 300-mg tablets BID. For the 400 mg BID dose reduction, one 300-mg and one 100-mg tablet. Both dose levels were administered without regard to food. Epacadostat was administered daily up to and including the day of surgery.

    Arm title
    Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
    Arm description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    INCAGN02385
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/mL administered intravenously (30-minute infusion with filter followed by flush)

    Investigational medicinal product name
    retifanlimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/mL liquid formulation administered intravenously over 30 minutes (+ 15 minutes) on Day 1 of each 28-day cycle

    Arm title
    Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Arm description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    retifanlimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/mL liquid formulation administered intravenously over 30 minutes (+ 15 minutes) on Day 1 of each 28-day cycle

    Investigational medicinal product name
    INCAGN02390
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/ mL administered intravenously (30-minute infusion with filter followed by flush) every 2 weeks

    Investigational medicinal product name
    INCAGN02385
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/mL administered intravenously (30-minute infusion with filter followed by flush) every 2 weeks

    Number of subjects in period 1
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Started
    3
    20
    2
    4
    1
    Completed
    2
    19
    2
    3
    1
    Not completed
    1
    1
    0
    1
    0
         Lost to follow-up
    1
    -
    -
    1
    -
         AE Delayed Surgery; No Follow-Up Data Collected
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W
    Reporting group description
    Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg Q4W
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Epacadostat 600 mg BID
    Reporting group description
    Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group values
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg Total
    Number of subjects
    3 20 2 4 1 30
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0
        Adults (18-64 years)
    0 5 1 0 0 6
        From 65-84 years
    3 15 1 4 1 24
        85 years and over
    0 0 0 0 0 0
    Age Continuous
    120=Mean (SD) age cannot be reported for a single participant due to privacy concerns.
    Units: years
        arithmetic mean (standard deviation)
    75.7 ( 6.66 ) 71.1 ( 6.08 ) 65.0 ( 1.41 ) 69.3 ( 3.86 ) 120 ( 120 ) -
    Sex/Gender, Customized
    Units: participants
        Female
    0 2 1 1 0 4
        Male
    3 18 1 3 0 25
        Cannot Be Reported Due to Participant Privacy
    0 0 0 0 1 1
    Race, Customized
    Units: Subjects
        White/Caucasian
    2 16 2 4 0 24
        Not Reported
    1 4 0 0 0 5
        Cannot Be Reported Due to Participant Privacy
    0 0 0 0 1 1
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    0 0 0 0 0 0
        Not Hispanic or Latino
    2 15 1 4 0 22
        Not Reported
    1 5 1 0 0 7
        Cannot Be Reported Due to Participant Privacy
    0 0 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W
    Reporting group description
    Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg Q4W
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Epacadostat 600 mg BID
    Reporting group description
    Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Primary: Change from Baseline in CD8+ lymphocytes within the resected tumor

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    End point title
    Change from Baseline in CD8+ lymphocytes within the resected tumor [1]
    End point description
    Fold Change from Baseline in CD8+ lymphocytes = CD8+ Lymphocytes at cystectomy divided by CD8+ lymphocytes at Screening. Analysis was conducted in members of the Translation Evaluable Population, comprised of all participants who enrolled in the study who received at least 4 weeks of neoadjuvant study treatment (needed to receive the last dose of epacadostat within 2 days prior to the day of surgery or needed to receive the last dose of retifanlimab and/or INCAGN02385 and/or INCAGN02390 within the 7 weeks prior to day of surgery) and provided evaluable paired biopsies (pretreatment core biopsy and surgical resection biopsy). Translational data in all but the retifanlimab 500 mg Q4W treatment group were limited and insufficient to assess this outcome measure.
    End point type
    Primary
    End point timeframe
    up to 69 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Number of subjects analysed
    0 [2]
    6 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: log 2 of fold change
        arithmetic mean (standard deviation)
    ( )
    0.791 ( 0.9332 )
    ( )
    ( )
    ( )
    Notes
    [2] - Translation Evaluable Population
    [3] - Translation Evaluable Population
    [4] - Translation Evaluable Population
    [5] - Translation Evaluable Population
    [6] - Translation Evaluable Population
    No statistical analyses for this end point

    Secondary: Number of participants with any ≥Grade 3 TEAE

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    End point title
    Number of participants with any ≥Grade 3 TEAE
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
    End point type
    Secondary
    End point timeframe
    up to 159 days
    End point values
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Number of subjects analysed
    3 [7]
    20 [8]
    2 [9]
    4 [10]
    1 [11]
    Units: participants
    2
    9
    0
    2
    1
    Notes
    [7] - Safety Population
    [8] - Safety Population
    [9] - Safety Population
    [10] - Safety Population
    [11] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-emergent adverse event (TEAE)

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    End point title
    Number of participants with any treatment-emergent adverse event (TEAE)
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study drug. Analysis was conducted in members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of the assigned study treatment.
    End point type
    Secondary
    End point timeframe
    up to 159 days
    End point values
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Number of subjects analysed
    3 [12]
    20 [13]
    2 [14]
    4 [15]
    1 [16]
    Units: participants
    3
    18
    2
    4
    1
    Notes
    [12] - Safety Population
    [13] - Safety Population
    [14] - Safety Population
    [15] - Safety Population
    [16] - Safety Population
    No statistical analyses for this end point

    Secondary: Major pathological response

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    End point title
    Major pathological response
    End point description
    Major pathological response was defined as the percentage of participants with residual ypT0/1/a/isN0M0.
    End point type
    Secondary
    End point timeframe
    up to 69 days
    End point values
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Number of subjects analysed
    2 [17]
    20 [18]
    2 [19]
    4 [20]
    1 [21]
    Units: percentage of participants
        number (confidence interval 80%)
    100 (31.62 to 100)
    50 (33.82 to 66.18)
    50 (5.13 to 94.87)
    50 (14.26 to 85.74)
    100 (10 to 100)
    Notes
    [17] - Efficacy Population
    [18] - Efficacy Population
    [19] - Efficacy Population
    [20] - Efficacy Population
    [21] - Efficacy Population
    No statistical analyses for this end point

    Secondary: Pathological complete response rate

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    End point title
    Pathological complete response rate
    End point description
    Pathological complete response rate was defined as the percentage of participants with ypT0N0. The 80% confidence interval was estimated using the Clopper-Pearson method. Analysis was conducted in members of the Efficacy Population, comprised of all participants with secondary efficacy endpoint data available for both Baseline and post-Baseline measurements.
    End point type
    Secondary
    End point timeframe
    up to 69 days
    End point values
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Number of subjects analysed
    2 [22]
    20 [23]
    2 [24]
    4 [25]
    1 [26]
    Units: percentage of participants
        number (confidence interval 80%)
    100 (31.62 to 100)
    40 (24.91 to 56.73)
    0 (0 to 68.38)
    0 (0 to 43.77)
    100 (10 to 100)
    Notes
    [22] - Efficacy Population
    [23] - Efficacy Population
    [24] - Efficacy Population
    [25] - Efficacy Population
    [26] - Efficacy Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 159 days
    Adverse event reporting additional description
    Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W
    Reporting group description
    Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg Q4W
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Epacadostat 600 mg BID
    Reporting group description
    Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Reporting group title
    Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Reporting group description
    Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.

    Serious adverse events
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 20 (20.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Ileus paralytic
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Purulent discharge
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Epacadostat 600 mg BID + retifanlimab 500 mg Q4W Retifanlimab 500 mg Q4W Epacadostat 600 mg BID Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W Retifanlimab 500 mg + INCAGN02385 350 mg + INCAGN02390 400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    18 / 20 (90.00%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
    1 / 1 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 20 (20.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 20 (15.00%)
    0 / 2 (0.00%)
    3 / 4 (75.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    3
    0
    3
    0
    Asthenia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 20 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    7
    1
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyperpyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Epididymal cyst
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Epididymal tenderness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Testicular swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Vaginal prolapse
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 20 (5.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Carbon dioxide increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Inflammatory marker increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Lipase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Post procedural discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Head injury
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 20 (25.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    8
    0
    7
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Anal incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aerophagia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 20 (15.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    Diarrhea
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 20 (5.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    4
    1
    3
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    0
    0
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bladder spasm
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Dysuria
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    5
    0
    Nocturia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Urinary retention
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    0
    1
    2
    Arthritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Infections and infestations
    Urinary tract infection pseudomonal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 20 (15.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    3
    0
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Klebsiella urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epididymitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Cystitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 20 (5.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 20 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    7
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 20 (0.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2020
    The primary purpose of this amendment was to address regulatory comments regarding eligibility criteria, secondary objective and endpoints, withdrawal criteria, and study conduct and additional feedback from investigators to clarify several errors and omissions.
    02 Feb 2021
    The sponsor evaluated its strategy in bladder cancer and made a decision to remove pemigatinib from this study. As such, this amendment removed the 3 treatment groups that contained pemigatinib (pemigatinib monotherapy, pemigatinib plus retifanlimab, and pemigatinib followed by retifanlimab). The removal of information on fibroblast growth factor receptor was reflected throughout the protocol.
    10 May 2021
    The primary purpose of this amendment was to address requested comments and changes from the French Health Authority Review.
    01 Mar 2022
    The primary purpose of this amendment was to add 2 new treatment groups to the Protocol (retifanlimab plus INCAGN02385 as well as retifanlimab plus INCAGN02385 plus INCAGN02390) and to clarify the radiologic tools used for tumor imaging.

    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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