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    Clinical Trial Results:
    A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti CTLA-4 Antibody) in the Second-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2017-003684-35
    Trial protocol
    		 DE   BE   GB   FR   PL   ES  
    Global end of trial date
    27 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2022
    First version publication date
    26 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R2810-ONC-1763
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03430063
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.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
    27 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the objective response rate (ORR) of high dose cemiplimab and standard dose cemiplimab plus ipilimumab combination therapy to the ORR of standard dose cemiplimab in the second-line treatment of subjects with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in subjects whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.
    Protection of trial subjects
    It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 May 2018
    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: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    28
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Due to early enrollment cessation, only 28 participants were randomized and 27 participants received study treatment in this study. One participant was randomized but not treated.

    Pre-assignment
    Screening details
    		 Of the 27 participants treated, four participants completed the study. The most common reason for study discontinuation was death (8 participants) followed by withdrawal of consent (6 participants), and progressive disease (4 participants).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cemiplimab 350 mg Q3W
    Arm description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cemiplimab
    Investigational medicinal product code
    REGN2810
    Other name
    LIBTAYO®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cemiplimab 350 mg Q3W for 108 weeks as an intravenous (IV) infusion

    Arm title
    		 Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
    Arm description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    YERVOY®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab 50 mg Q6W for up to 4 doses as an IV infusion

    Investigational medicinal product name
    cemiplimab
    Investigational medicinal product code
    REGN2810
    Other name
    LIBTAYO®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cemiplimab 350 mg Q3W for 108 weeks as an intravenous (IV) infusion

    Arm title
    		 Cemiplimab 1050 mg Q3W
    Arm description
    		 Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cemiplimab
    Investigational medicinal product code
    REGN2810
    Other name
    LIBTAYO®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cemiplimab 1050 mg Q3W for 108 weeks as an IV infusion

    Number of subjects in period 1 [1]
    		Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Started
    8
    11
    8
    Completed
    0
    3
    1
    Not completed
    8
    8
    7
         Adverse event, serious fatal
    3
    2
    3
         Consent withdrawn by subject
    3
    1
    2
         Adverse event, non-fatal
    -
    1
    -
         Un-specified
    1
    1
    -
         Withdrawal by Subject
    -
    -
    1
         Progressive disease
    1
    2
    1
         Lost to follow-up
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 28 participants were enrolled and randomized, out of which 27 participants received study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cemiplimab 350 mg Q3W
    Reporting group description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Reporting group title
    Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
    Reporting group description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment

    Reporting group title
    Cemiplimab 1050 mg Q3W
    Reporting group description
    		 Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Reporting group values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W Total
    Number of subjects
    		 8 11 8 27
    Age categorical
    Units: Participants
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.4 ± 7.91 68.5 ± 8.72 68.1 ± 12.08 -
    Gender categorical
    Units: Participants
        Female
    		 2 4 1 7
        Male
    		 6 7 7 20
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 6 7 6 19
        Unknown or Not Reported
    		 2 4 2 8
    Race
    Units: Subjects
        Asian
    		 6 3 3 12
        White
    		 0 5 3 8
        Unknown or Not Reported
    		 2 3 2 7

    End points

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    End points reporting groups
    Reporting group title
    Cemiplimab 350 mg Q3W
    Reporting group description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Reporting group title
    Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
    Reporting group description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment

    Reporting group title
    Cemiplimab 1050 mg Q3W
    Reporting group description
    		 Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Primary: Objective Response Rate (ORR) in Participants whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells

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    End point title
    		 Objective Response Rate (ORR) in Participants whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells [1]
    End point description
    ORR was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or date of subsequent anti-cancer therapy, whichever came first. CR was defined as disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Safety analysis set (SAF): all randomized participants who received any study drug; it is based on the treatment received (as treated).
    End point type
    Primary
    End point timeframe
    From date of randomization up to 41 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: No statistical and comparison analysis were performed for this endpoint.
    End point values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Number of subjects analysed
    8
    11
    8
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 36.9)
    45.5 (16.7 to 76.6)
    0 (0.0 to 36.9)
    No statistical analyses for this end point

    Secondary: Overall Response Rate

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    End point title
    		 Overall Response Rate
    End point description
    Overall Response Rate was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) RECIST 1.1 between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SAF included all randomized subjects who received any study drug; it is based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    From date of randomization up to 41 months
    End point values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Number of subjects analysed
    8
    11
    8
    Units: Percentage of participants
    number (not applicable)
        Complete Response
    0
    0
    0
        Partial Response
    0
    45.5
    0
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) in Participants with Tumor PD-L1 Expression Levels <50% of Tumor Cells

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    End point title
    		 Overall Survival (OS) in Participants with Tumor PD-L1 Expression Levels <50% of Tumor Cells
    End point description
    OS was defined as the time from randomization to the date of death due to any cause. A participant who lost to follow-up was censored at the last date that the participant was known to be alive. OS was measured using Kaplan-Meier method. SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated). Here, 99999 indicates data could not be estimated due to higher number (> 50%) of censored participants.
    End point type
    Secondary
    End point timeframe
    Time from randomization to the date of death (up to 41 months)
    End point values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Number of subjects analysed
    8
    11
    8
    Units: Months
        median (confidence interval 95%)
    5.1 (1.7 to 99999)
    99999 (2.2 to 99999)
    8.4 (1.4 to 99999)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells

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    End point title
    		 Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
    End point description
    PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the IRC (based on RECIST 1.1 assessments) or death due to any cause, whichever occurred earlier. PFS was measured using Kaplan-Meier method. SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated). Here, 99999 indicates that upper limit of 95% CI was not estimable due to low number of events.
    End point type
    Secondary
    End point timeframe
    Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)
    End point values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Number of subjects analysed
    8
    11
    8
    Units: Months
        median (confidence interval 95%)
    2.0 (0.7 to 8.3)
    20.8 (1.2 to 99999)
    1.8 (1.1 to 2.2)
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
    End point description
    Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Number of participants with TEAEs, Serious TEAEs and TEAEs leading to death were reported. SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to 41 months
    End point values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Number of subjects analysed
    8
    11
    8
    Units: Count of participants
        Participants with any TEAE
    7
    11
    8
        Participants with any serious TEAE
    1
    7
    4
        Participants with any TEAE resulting in death
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System

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    End point title
    		 Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System
    End point description
    The laboratory measurements included hematology, chemistry, electrolytes and liver function. NCI-CTCAE was graded according to the following scale: Grade 1 (Mild): Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 (Moderate): Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3 (Severe): Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4 (Life–threatening): Life-threatening consequences; urgent intervention indicated; Grade 5 (Death): Death related to AE. Safety Analysis Set included all randomized subjects who received any study drug; it is based on the treatment received (as treated). SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Up to 41 months
    End point values
    		 Cemiplimab 350 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W Cemiplimab 1050 mg Q3W
    Number of subjects analysed
    8
    11
    8
    Units: Count of participants
        Hematology
    2
    3
    5
        Electrolytes
    3
    3
    1
        Liver Function
    2
    3
    1
        Chemistry
    1
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose up to 41 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Cemiplimab 350 mg Q3W
    Reporting group description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Reporting group title
    Cemiplimab 1050 mg Q3W
    Reporting group description
    		 Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Reporting group title
    Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
    Reporting group description
    		 Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

    Serious adverse events
    		 Cemiplimab 350 mg Q3W Cemiplimab 1050 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 8 (50.00%)
    7 / 11 (63.64%)
         number of deaths (all causes)
    3
    4
    3
         number of deaths resulting from adverse events
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain stem embolism
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradypnoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    3 / 11 (27.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cemiplimab 350 mg Q3W Cemiplimab 1050 mg Q3W Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    8 / 8 (100.00%)
    11 / 11 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin cancer
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    5
    Asthenia
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    2
    0
    5
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    2
    Infusion site extravasation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    0
    Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Oedema
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Contrast media reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Pelvic pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 8 (25.00%)
    3 / 11 (27.27%)
         occurrences all number
    2
    2
    4
    Haemoptysis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    2
    Productive cough
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    0
    1
    2
    Dysphonia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Wheezing
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Respiratory failure
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    5
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    2
    Nervousness
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    3
    Anxiety
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    0
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Blood lactic acid increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    1
    Blood urea increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    Lipase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Transaminases increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Head injury
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    4
    Presyncope
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Dysarthria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    1
    Cauda equina syndrome
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    2
    1
    Pancytopenia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Vestibular disorder
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Eyelid ptosis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 8 (12.50%)
    3 / 11 (27.27%)
         occurrences all number
    2
    1
    3
    Constipation
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 8 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    3
    1
    5
    Vomiting
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    3
    0
    2
    Nausea
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 8 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    2
    1
    2
    Dry mouth
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Oral lichen planus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    0
    Oral lichenoid reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    3 / 11 (27.27%)
         occurrences all number
    2
    1
    3
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    2
    Dry skin
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Eczema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Lichen planus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    Urticaria
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Umbilical erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Skin odour abnormal
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    3
    Hyperthyroidism
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 8 (25.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    2
    Hypophysitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    3 / 11 (27.27%)
         occurrences all number
    2
    0
    3
    Bone pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    2
    Back pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    3 / 11 (27.27%)
         occurrences all number
    1
    1
    3
    Musculoskeletal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    Arthritis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Fasciitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Decreased appetite
         subjects affected / exposed
    4 / 8 (50.00%)
    3 / 8 (37.50%)
    3 / 11 (27.27%)
         occurrences all number
    4
    4
    6
    Hypercalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 May 2018
    • Changed the study population enrollment criteria from NSCLC patients with PD-L1 expression in <50% of tumor cells to include those with PD-L1 expression in ≥50% of tumor cells. • Updated the planned patient enrollment number from approximately 201 to approximately 252. • Specified that serum samples collected for cemiplimab ADA assessment may be used for evaluation of ipilimumab ADA, if in the future it becomes necessary to evaluate ipilimumab ADA. • Added inclusion of NSCLC patients with stage IIIc disease • Removed from Inclusion Criteria patients with ‘anticipated life expectancy of at least 3 months’ • Modified exclusion criteria to be defined as occurring ‘prior to randomization’ rather than ‘prior to informed consent,’ ‘prior to enrollment,’ or prior to study entry.’ • Added an exclusion criterion to prohibit enrollment of patients with ‘prior treatment with an anti-CTLA-4 antibody or anti-PD˗1/PD˗L1 for advanced disease.’ • Specified that patients who continue treatment beyond the initial determination of progressive disease would be required to re-consent using a separate ICF • Changed and updated stratification of patients at randomization by PD-L1 expression in tumor cells from ‘<1% versus 1% to <50%’ to ‘<1% versus 1% to 49% versus ≥50%’. • Revised sampling times for PK and ADA analyses • Changed the definition of acute infusion reactions window from ‘within 2 hours after the infusion’ to ‘within 1 day after the infusion’ • Changed adverse events reporting requirement window from ‘within 105 days after the last study treatment’ to ‘within 90 days after the last study treatment’ • Added text specifying the primary endpoint applies to patients whose tumors express PD-L1 in <50% of tumor cells • Added a secondary objective to compare the ORR in patients with PD-L1 in ≥50% of tumor cells and in all patients and a corresponding secondary endpoint to evaluate ORR in all patients • Revised, added, or removed text, including redundant text, for clarity.

    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.
    All participants’ tumors had PD-L1 expression levels of <50% at baseline. Therefore, the results do not present efficacy for participants with PD-L1 expression levels of ≥50% of tumor cells versus all participants.
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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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