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    Clinical Trial Results:
    A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

    Summary
    EudraCT number
    		 2018-002941-12
    Trial protocol
    		 AT   HU   PL   ES   IT   RO  
    Global end of trial date
    28 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2023
    First version publication date
    12 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCMGA 0012-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03679767
    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
    28 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This trial was conducted to assess the efficacy of INCMGA00012 in terms of the overall response rate (ORR) in tumor types of interest.
    Protection of trial subjects
    This study was to be 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
    09 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Romania: 24
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    121
    EEA total number of subjects
    104
    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)
    44
    From 65 to 84 years
    69
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 34 study centers in Austria, Spain, France, Hungary, Italy, Poland, Romania, and the United States.

    Pre-assignment
    Screening details
    		 A total of 121 participants with advanced solid tumors (melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma) were enrolled in the study and treated with retifanlimab.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Melanoma
    Arm description
    		 Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Retifanlimab
    Investigational medicinal product code
    INCMGA00012
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg Q4W

    Arm title
    		 Non-small Cell Lung Cancer
    Arm description
    		 Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Retifanlimab
    Investigational medicinal product code
    INCMGA00012
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg Q4W

    Arm title
    		 Urethelial Carcinoma
    Arm description
    		 Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Retifanlimab
    Investigational medicinal product code
    INCMGA00012
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg Q4W

    Arm title
    		 Renal Cell Carcinoma
    Arm description
    		 Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Retifanlimab
    Investigational medicinal product code
    INCMGA00012
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg Q4W

    Number of subjects in period 1
    		Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Started
    35
    23
    29
    34
    Completed
    0
    0
    0
    0
    Not completed
    35
    23
    29
    34
         Adverse event, serious fatal
    16
    11
    17
    10
         Consent withdrawn by subject
    -
    -
    -
    1
         Follow-up Completed
    18
    11
    11
    20
         Progressive Disease
    -
    -
    -
    1
         Lost to follow-up
    1
    1
    1
    1
         Entered Hospice Care
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Melanoma
    Reporting group description
    		 Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).

    Reporting group title
    Non-small Cell Lung Cancer
    Reporting group description
    		 Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group title
    Urethelial Carcinoma
    Reporting group description
    		 Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group title
    Renal Cell Carcinoma
    Reporting group description
    		 Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma Total
    Number of subjects
    		 35 23 29 34 121
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 14 9 6 15 44
        From 65-84 years
    		 16 13 22 18 69
        85 years and over
    		 5 1 1 1 8
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 67.2 ( 15.24 ) 67.8 ( 8.68 ) 72.0 ( 8.23 ) 66.6 ( 10.28 ) -
    Sex: Female, Male
    Units:
        Female
    		 20 7 4 10 41
        Male
    		 15 16 25 24 80
    Race, Customized
    Units: Subjects
        White/Caucasian
    		 35 22 20 33 110
        Asian
    		 0 1 0 0 1
        Not Reported
    		 0 0 9 1 10
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 4 0 1 0 5
        Not Hispanic or Latino
    		 30 22 12 29 93
        Not Reported
    		 1 1 16 5 23

    End points

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    End points reporting groups
    Reporting group title
    Melanoma
    Reporting group description
    		 Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).

    Reporting group title
    Non-small Cell Lung Cancer
    Reporting group description
    		 Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group title
    Urethelial Carcinoma
    Reporting group description
    		 Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group title
    Renal Cell Carcinoma
    Reporting group description
    		 Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Subject analysis set title
    All Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W. Participants received at least 1 dose of study drug and provided a Baseline and at least 1 postdose pharmacokinetic sample.

    Primary: Overall response rate (ORR)

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    End point title
    		 Overall response rate (ORR) [1]
    End point description
    ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Participants were to be analyzed based on disease-specific diagnosis. Confidence intervals were calculated based on the exact method for binomial distributions.
    End point type
    Primary
    End point timeframe
    up to 25.9 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Number of subjects analysed
    35
    23
    29
    34
    Units: percentage of participants
        number (confidence interval 95%)
    40.0 (23.9 to 57.9)
    34.8 (16.4 to 57.3)
    37.9 (20.7 to 57.7)
    23.5 (10.7 to 41.2)
    No statistical analyses for this end point

    Secondary: Duration of response (DOR)

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    End point title
    		 Duration of response (DOR)
    End point description
    DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation. 9999=The median and upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to 24.0 months
    End point values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Number of subjects analysed
    14 [2]
    8 [3]
    11 [4]
    8 [5]
    Units: months
        median (confidence interval 95%)
    9999 (9.2 to 9999)
    18.2 (1.9 to 9999)
    11.5 (2.2 to 9999)
    9999 (2.8 to 9999)
    Notes
    [2] - Only those participants with a CR or PR were included in the analysis.
    [3] - Only those participants with a CR or PR were included in the analysis.
    [4] - Only those participants with a CR or PR were included in the analysis.
    [5] - Only those participants with a CR or PR were included in the analysis.
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR)

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    End point title
    		 Disease control rate (DCR)
    End point description
    DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. Confidence intervals were calculated based on the exact method for binomial distributions.
    End point type
    Secondary
    End point timeframe
    up to 25.9 months
    End point values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Number of subjects analysed
    35
    23
    29
    34
    Units: percentage of participants
        number (confidence interval 95%)
    54.3 (36.6 to 71.2)
    65.2 (42.7 to 83.6)
    55.2 (35.7 to 73.6)
    64.7 (46.5 to 80.3)
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression. Median PFS was estimated using the Kaplan-Meier method. The confidence interval for median PFS was calculated using the method of Brookmeyer and Crowley. 9999=The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
    End point type
    Secondary
    End point timeframe
    up to 25.9 months
    End point values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Number of subjects analysed
    35
    23
    29
    34
    Units: months
        median (confidence interval 95%)
    3.6 (1.8 to 9999)
    4.4 (1.8 to 21.9)
    5.7 (1.8 to 13.6)
    5.4 (2.3 to 11.4)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause. Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. -9999, 9999=The median and the upper and lower limits of the confidence interval were not estimable because too few participants had events of death.
    End point type
    Secondary
    End point timeframe
    up to 28.2 months
    End point values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Number of subjects analysed
    35
    23
    29
    34
    Units: months
        median (confidence interval 95%)
    9999 (8.7 to 9999)
    21.9 (5.2 to 9999)
    15.2 (7.7 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of participants with treatment-emergent adverse events (TEAEs)
    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 considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
    End point type
    Secondary
    End point timeframe
    up to approximately 2.3 years
    End point values
    		 Melanoma Non-small Cell Lung Cancer Urethelial Carcinoma Renal Cell Carcinoma
    Number of subjects analysed
    35
    23
    29
    34
    Units: participants
        number (not applicable)
    32
    21
    28
    32
    No statistical analyses for this end point

    Secondary: First-dose Cmax of retifanlimab

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    End point title
    		 First-dose Cmax of retifanlimab
    End point description
    Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: milligrams per Liter (mg/L)
        arithmetic mean (standard deviation)
    143 ( 30.9 )
    No statistical analyses for this end point

    Secondary: tmax of retifanlimab at steady-state

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    End point title
    		 tmax of retifanlimab at steady-state
    End point description
    tmax was defined as the time to the maximum concentration of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: hours
        median (full range (min-max))
    0.500 (0.500 to 1.00)
    No statistical analyses for this end point

    Secondary: First-dose tmax of retifanlimab

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    End point title
    		 First-dose tmax of retifanlimab
    End point description
    tmax was defined as the time to the maximum concentration of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: hours
        median (full range (min-max))
    0.500 (0.500 to 1.00)
    No statistical analyses for this end point

    Secondary: Cmax of retifanlimab at steady-state

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    End point title
    		 Cmax of retifanlimab at steady-state
    End point description
    Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: mg/L
        arithmetic mean (standard deviation)
    181 ( 39.4 )
    No statistical analyses for this end point

    Secondary: First-dose AUC0-t of retifanlimab

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    End point title
    		 First-dose AUC0-t of retifanlimab
    End point description
    AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: day*mg/L
        arithmetic mean (standard deviation)
    1620 ( 506 )
    No statistical analyses for this end point

    Secondary: Cmin of retifanlimabv at steady-state

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    End point title
    		 Cmin of retifanlimabv at steady-state
    End point description
    Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: mg/L
        arithmetic mean (standard deviation)
    38.2 ( 16.3 )
    No statistical analyses for this end point

    Secondary: First-dose Cmin of retifanlimab

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    End point title
    		 First-dose Cmin of retifanlimab
    End point description
    Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: mg/L
        arithmetic mean (standard deviation)
    18.0 ( 7.52 )
    No statistical analyses for this end point

    Secondary: AUC0-t of retifanlimab at steady-state

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    End point title
    		 AUC0-t of retifanlimab at steady-state
    End point description
    AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
    End point type
    Secondary
    End point timeframe
    preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
    End point values
    		 All Participants
    Number of subjects analysed
    121
    Units: day*mg/L
        arithmetic mean (standard deviation)
    2030 ( 566 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to approximately 2.3 years
    Adverse event reporting additional description
    Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Melanoma
    Reporting group description
    		 Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).

    Reporting group title
    Non-small Cell Lung Cancer
    Reporting group description
    		 Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Renal Cell Carcinoma
    Reporting group description
    		 Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Reporting group title
    Urothelial Cancer
    Reporting group description
    		 Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

    Serious adverse events
    		 Melanoma Non-small Cell Lung Cancer Total Renal Cell Carcinoma Urothelial Cancer
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 35 (22.86%)
    9 / 23 (39.13%)
    40 / 121 (33.06%)
    11 / 34 (32.35%)
    12 / 29 (41.38%)
         number of deaths (all causes)
    16
    11
    54
    10
    17
         number of deaths resulting from adverse events
    2
    1
    7
    2
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial occlusive disease
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Hyperthermia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 23 (8.70%)
    4 / 121 (3.31%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    2 / 121 (1.65%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paroxysmal atrioventricular block
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cognitive disorder
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    2 / 2
         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
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypophysitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone lesion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 23 (4.35%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 23 (13.04%)
    6 / 121 (4.96%)
    3 / 34 (8.82%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 6
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 23 (4.35%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    1 / 121 (0.83%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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: 5%
    Non-serious adverse events
    		 Melanoma Non-small Cell Lung Cancer Total Renal Cell Carcinoma Urothelial Cancer
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 35 (85.71%)
    19 / 23 (82.61%)
    104 / 121 (85.95%)
    30 / 34 (88.24%)
    25 / 29 (86.21%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    6 / 121 (4.96%)
    2 / 34 (5.88%)
    3 / 29 (10.34%)
         occurrences all number
    0
    2
    8
    2
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 35 (20.00%)
    2 / 23 (8.70%)
    24 / 121 (19.83%)
    6 / 34 (17.65%)
    9 / 29 (31.03%)
         occurrences all number
    11
    2
    31
    7
    11
    Chills
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    3
    1
    2
    Fatigue
         subjects affected / exposed
    6 / 35 (17.14%)
    2 / 23 (8.70%)
    12 / 121 (9.92%)
    2 / 34 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    7
    2
    13
    2
    2
    Malaise
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    0
    3
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 23 (4.35%)
    10 / 121 (8.26%)
    3 / 34 (8.82%)
    5 / 29 (17.24%)
         occurrences all number
    1
    1
    11
    4
    5
    Pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    2 / 34 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    3
    2
    1
    Pyrexia
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 23 (8.70%)
    13 / 121 (10.74%)
    4 / 34 (11.76%)
    4 / 29 (13.79%)
         occurrences all number
    6
    2
    23
    8
    7
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 23 (0.00%)
    9 / 121 (7.44%)
    4 / 34 (11.76%)
    1 / 29 (3.45%)
         occurrences all number
    5
    0
    13
    4
    4
    Dyspnoea
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 23 (13.04%)
    12 / 121 (9.92%)
    6 / 34 (17.65%)
    1 / 29 (3.45%)
         occurrences all number
    4
    3
    14
    6
    1
    Dyspnoea exertional
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 23 (8.70%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    3
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    3
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 23 (8.70%)
    5 / 121 (4.13%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences all number
    3
    2
    6
    1
    0
    Confusional state
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    0
    4
    0
    4
    Insomnia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    5 / 121 (4.13%)
    3 / 34 (8.82%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    5
    3
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 23 (13.04%)
    7 / 121 (5.79%)
    2 / 34 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    4
    8
    2
    1
    Amylase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 23 (8.70%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 23 (13.04%)
    4 / 121 (3.31%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    4
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 23 (4.35%)
    9 / 121 (7.44%)
    2 / 34 (5.88%)
    5 / 29 (17.24%)
         occurrences all number
    1
    1
    10
    3
    5
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    0
    2
    Lipase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    4
    3
    0
    Weight decreased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    4 / 121 (3.31%)
    2 / 34 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    4
    2
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 35 (20.00%)
    1 / 23 (4.35%)
    9 / 121 (7.44%)
    0 / 34 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    7
    2
    10
    0
    1
    Paraesthesia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 23 (0.00%)
    8 / 121 (6.61%)
    4 / 34 (11.76%)
    1 / 29 (3.45%)
         occurrences all number
    3
    0
    8
    4
    1
    Somnolence
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    3 / 121 (2.48%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    3
    2
    0
    Sciatica
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    5
    1
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 23 (4.35%)
    17 / 121 (14.05%)
    5 / 34 (14.71%)
    9 / 29 (31.03%)
         occurrences all number
    2
    1
    17
    5
    9
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    3
    1
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 23 (0.00%)
    6 / 121 (4.96%)
    1 / 34 (2.94%)
    1 / 29 (3.45%)
         occurrences all number
    4
    0
    6
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    5 / 121 (4.13%)
    1 / 34 (2.94%)
    3 / 29 (10.34%)
         occurrences all number
    1
    0
    6
    2
    3
    Constipation
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 23 (8.70%)
    14 / 121 (11.57%)
    5 / 34 (14.71%)
    6 / 29 (20.69%)
         occurrences all number
    1
    2
    17
    5
    9
    Dry mouth
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    5 / 121 (4.13%)
    3 / 34 (8.82%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    5
    3
    1
    Diarrhoea
         subjects affected / exposed
    7 / 35 (20.00%)
    3 / 23 (13.04%)
    19 / 121 (15.70%)
    4 / 34 (11.76%)
    5 / 29 (17.24%)
         occurrences all number
    22
    3
    38
    7
    6
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    4 / 121 (3.31%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    4
    2
    0
    Nausea
         subjects affected / exposed
    5 / 35 (14.29%)
    0 / 23 (0.00%)
    12 / 121 (9.92%)
    3 / 34 (8.82%)
    4 / 29 (13.79%)
         occurrences all number
    5
    0
    12
    3
    4
    Toothache
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 23 (4.35%)
    6 / 121 (4.96%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    3
    1
    9
    1
    4
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 23 (4.35%)
    10 / 121 (8.26%)
    4 / 34 (11.76%)
    2 / 29 (6.90%)
         occurrences all number
    3
    1
    12
    5
    3
    Erythema
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 23 (13.04%)
    5 / 121 (4.13%)
    1 / 34 (2.94%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    8
    4
    1
    Skin toxicity
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    3
    1
    2
    Pruritus
         subjects affected / exposed
    9 / 35 (25.71%)
    3 / 23 (13.04%)
    21 / 121 (17.36%)
    5 / 34 (14.71%)
    4 / 29 (13.79%)
         occurrences all number
    12
    3
    25
    5
    5
    Rash
         subjects affected / exposed
    5 / 35 (14.29%)
    2 / 23 (8.70%)
    15 / 121 (12.40%)
    5 / 34 (14.71%)
    3 / 29 (10.34%)
         occurrences all number
    12
    2
    22
    5
    3
    Rash macular
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    1 / 34 (2.94%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    3
    1
    0
    Vitiligo
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Dysuria
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    5 / 121 (4.13%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    2
    0
    5
    1
    2
    Haematuria
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    3
    0
    2
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 23 (4.35%)
    3 / 121 (2.48%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    3
    2
    0
    Hypothyroidism
         subjects affected / exposed
    5 / 35 (14.29%)
    1 / 23 (4.35%)
    11 / 121 (9.09%)
    3 / 34 (8.82%)
    2 / 29 (6.90%)
         occurrences all number
    5
    1
    11
    3
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 23 (4.35%)
    10 / 121 (8.26%)
    2 / 34 (5.88%)
    4 / 29 (13.79%)
         occurrences all number
    3
    1
    11
    3
    4
    Arthralgia
         subjects affected / exposed
    8 / 35 (22.86%)
    0 / 23 (0.00%)
    21 / 121 (17.36%)
    5 / 34 (14.71%)
    8 / 29 (27.59%)
         occurrences all number
    10
    0
    38
    13
    15
    Groin pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    3
    0
    2
    Muscular weakness
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Myalgia
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 23 (4.35%)
    6 / 121 (4.96%)
    1 / 34 (2.94%)
    2 / 29 (6.90%)
         occurrences all number
    2
    1
    6
    1
    2
    Neck pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    0 / 34 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    4
    0
    3
    Pain in extremity
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 23 (4.35%)
    8 / 121 (6.61%)
    2 / 34 (5.88%)
    3 / 29 (10.34%)
         occurrences all number
    2
    1
    10
    2
    5
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    0 / 34 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 23 (0.00%)
    3 / 121 (2.48%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    3
    2
    0
    Skin infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    3
    3
    0
    Pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 23 (8.70%)
    7 / 121 (5.79%)
    4 / 34 (11.76%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    9
    6
    0
    Rash pustular
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    2 / 121 (1.65%)
    2 / 34 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 35 (8.57%)
    5 / 23 (21.74%)
    17 / 121 (14.05%)
    5 / 34 (14.71%)
    4 / 29 (13.79%)
         occurrences all number
    4
    6
    21
    6
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 35 (11.43%)
    5 / 23 (21.74%)
    19 / 121 (15.70%)
    3 / 34 (8.82%)
    7 / 29 (24.14%)
         occurrences all number
    4
    5
    20
    3
    8
    Hyperglycaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 23 (4.35%)
    5 / 121 (4.13%)
    2 / 34 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    6
    2
    2
    Hypercalcaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 23 (0.00%)
    4 / 121 (3.31%)
    2 / 34 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    4
    2
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 23 (8.70%)
    6 / 121 (4.96%)
    2 / 34 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    6
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2019
    The primary purpose of this amendment was to address comments regarding the design of the study.
    09 Aug 2019
    The main purpose of this amendment was to update the Protocol based on the information from the ongoing Phase 1 study, INCMGA 0012-101, and to update the pharmacokinetic sample collection schedule.
    10 Dec 2019
    The main purpose of this amendment was to adjust the overall study enrolment and statistical analysis, remove interim analysis and update the guidance for suspected immune related adverse events based on the data from ongoing studies with INCMGA00012 and recent Investigator's Brochure update.
    25 Nov 2020
    The main purpose of this amendment was to minimize the burden of data collection for ongoing participants after the primary objective of the study had been achieved. Disease follow-up and survival follow-up were removed.
    23 Jun 2021
    The purpose of this amendment was to update the guidelines for management of suspected immune related events.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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