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    Clinical Trial Results:
    A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma

    Summary
    EudraCT number
    		 2015-002971-12
    Trial protocol
    		 GB   DK   IT  
    Global end of trial date
    31 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2025
    First version publication date
    17 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IMCgp100-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02535078
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Immunocore Limited
    Sponsor organisation address
    92 Park Drive, Milton Park, Abingdon, United Kingdom, OX14 4RY
    Public contact
    Information Desk, Immunocore Limited, 44 01235438600, info@immunocore.com
    Scientific contact
    Regulatory Affairs, Immunocore Limited , 1 2673324508, Regaffairsgroup@immunocore.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
    19 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was a Phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent, and in combination with durvalumab and/or tremelimumab, in metastatic cutaneous melanoma. The purpose of this study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and to evaluate the anti-tumor activity of tebentafusp (IMCgp100) in combination with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab, compared to single-agent tebentafusp (IMCgp100) alone administered intravenously (iv) or subcutaneously (sc). As of Amendment 9, a potential Phase II portion of the study was to be opened after identification of the recommended Phase II dose (RP2D) for Arm 5 (tebentafusp sc monotherapy). However, the Phase II portion of the study was never initiated. Arm 5 was conducted in the US only.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice (GCP) standards, the Declaration of Helsinki, and all applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2015
    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
    Canada: 1
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    United States: 54
    Worldwide total number of subjects
    112
    EEA total number of subjects
    34
    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)
    73
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 22 study sites in 6 countries.

    Pre-assignment
    Screening details
    		 Prescreening: HLA-A*0201 positive (eligible) / non-HLA-A*0201 subtype (not eligible; eg, *0202, *0203 etc), or HLA-A2 negative (not eligible) All patients screened N=151 n=38 screen failure. Most common reason for screen failure was presence of untreated or symptomatic CNS metastases or CNS metastases that currently required local therapy.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1: Tebentafusp + Durvalumab
    Arm description
    		 IV Tebentafusp (IMCgp100) with durvalumab(MEDI4736)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tebentafusp
    Investigational medicinal product code
    Other name
    IMCgp100
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Soluble gp100-specific T cell receptor withanti-CD3 scFV

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    MEDI4736
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Anti-PD-L1 monoclonal antibody

    Arm title
    		 Arm 2: Tebentafusp + Tremelimumab
    Arm description
    		 IV Tebentafusp (IMCgp100) with tremelimumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tebentafusp
    Investigational medicinal product code
    Other name
    IMCgp100
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Soluble gp100-specific T cell receptor withanti-CD3 scFV

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Anti-CTLA-4 monoclonal antibody

    Arm title
    		 Arm 3: Tebentafusp + Durvalumab +Tremelimumab
    Arm description
    		 IV Tebentafusp (IMCgp100) with durvalumab (MEDI4736) and tremelimumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tebentafusp
    Investigational medicinal product code
    Other name
    IMCgp100
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Soluble gp100-specific T cell receptor withanti-CD3 scFV

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    MEDI4736
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Anti-PD-L1 monoclonal antibody

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Anti-CTLA-4 monoclonal antibody

    Arm title
    		 Arm 4a: Tebentafusp IV Monotherapy
    Arm description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion once weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tebentafusp
    Investigational medicinal product code
    Other name
    IMCgp100
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Soluble gp100-specific T cell receptor withanti-CD3 scFV

    Arm title
    		 Arm 4b: Tebentafusp IV Monotherapy
    Arm description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion 3 times weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tebentafusp
    Investigational medicinal product code
    Other name
    IMCgp100
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Soluble gp100-specific T cell receptor withanti-CD3 scFV

    Number of subjects in period 1
    		Arm 1: Tebentafusp + Durvalumab Arm 2: Tebentafusp + Tremelimumab Arm 3: Tebentafusp + Durvalumab +Tremelimumab Arm 4a: Tebentafusp IV Monotherapy Arm 4b: Tebentafusp IV Monotherapy
    Started
    43
    13
    29
    20
    7
    Completed
    36
    8
    24
    13
    6
    Not completed
    7
    5
    5
    7
    1
         Consent withdrawn by subject
    3
    2
    1
    2
    1
         Not specified
    -
    1
    -
    1
    -
         Lost to follow-up
    -
    1
    1
    1
    -
         Sponsor termination
    4
    1
    3
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: Tebentafusp + Durvalumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with durvalumab(MEDI4736)

    Reporting group title
    Arm 2: Tebentafusp + Tremelimumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with tremelimumab

    Reporting group title
    Arm 3: Tebentafusp + Durvalumab +Tremelimumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with durvalumab (MEDI4736) and tremelimumab

    Reporting group title
    Arm 4a: Tebentafusp IV Monotherapy
    Reporting group description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion once weekly

    Reporting group title
    Arm 4b: Tebentafusp IV Monotherapy
    Reporting group description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion 3 times weekly

    Reporting group values
    		 Arm 1: Tebentafusp + Durvalumab Arm 2: Tebentafusp + Tremelimumab Arm 3: Tebentafusp + Durvalumab +Tremelimumab Arm 4a: Tebentafusp IV Monotherapy Arm 4b: Tebentafusp IV Monotherapy Total
    Number of subjects
    		 43 13 29 20 7 112
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 29 11 18 11 4 73
        From 65-84 years
    		 14 2 11 9 3 39
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.9 ( 13.09 ) 53.4 ( 12.34 ) 57.1 ( 13.19 ) 58.6 ( 16.28 ) 53.3 ( 11.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 3 11 5 3 40
        Male
    		 25 10 18 15 4 72
    Race
    Units: Subjects
        Asian
    		 1 0 0 0 0 1
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Native Hawaiian or Other Pacific Islanders
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0
        White
    		 40 13 29 20 7 109
        Not Reported
    		 2 0 0 0 0 2
        Not allowed as per local regulatory
    		 0 0 0 0 0 0
        Other
    		 0 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 1 0 1
        Not Hispanic or Latino
    		 40 13 27 19 6 105
        Not Reported
    		 2 0 1 0 1 4
        Unknown
    		 1 0 1 0 0 2
        Other
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: Tebentafusp + Durvalumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with durvalumab(MEDI4736)

    Reporting group title
    Arm 2: Tebentafusp + Tremelimumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with tremelimumab

    Reporting group title
    Arm 3: Tebentafusp + Durvalumab +Tremelimumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with durvalumab (MEDI4736) and tremelimumab

    Reporting group title
    Arm 4a: Tebentafusp IV Monotherapy
    Reporting group description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion once weekly

    Reporting group title
    Arm 4b: Tebentafusp IV Monotherapy
    Reporting group description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion 3 times weekly

    Primary: Number of participants with dose-limiting toxicities (DLTs)

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    End point title
    		 Number of participants with dose-limiting toxicities (DLTs) [1] [2]
    End point description
    The number of participants with a DLT is reported. A DLT was defined as an AE or abnormal laboratory finding assessed as having had a suspected relationship to investigational product; being unrelated to disease, disease progression, intercurrent illness, or concomitant medications; and met other protocol-defined criteria.
    End point type
    Primary
    End point timeframe
    Up to ~2 years
    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: There are no statistical analyses for descriptive data
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects in Arm 4b were included in the DLT data set (i.e. there were no participants in this arm with at least one DLT)
    End point values
    		 Arm 1: Tebentafusp + Durvalumab Arm 2: Tebentafusp + Tremelimumab Arm 3: Tebentafusp + Durvalumab +Tremelimumab Arm 4a: Tebentafusp IV Monotherapy
    Number of subjects analysed
    33
    7
    28
    14
    Units: Participants
    1
    1
    0
    0
    No statistical analyses for this end point

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [3]
    End point description
    ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR). ORR was assessed using RECIST version 1.1.
    End point type
    Primary
    End point timeframe
    Up to ~2 years
    Notes
    [3] - 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: The primary objective of Phase II was ORR of tebentafusp using RECIST version 1.1 criteria. Phase II was not initiated.
    End point values
    		 Arm 1: Tebentafusp + Durvalumab Arm 2: Tebentafusp + Tremelimumab Arm 3: Tebentafusp + Durvalumab +Tremelimumab Arm 4a: Tebentafusp IV Monotherapy Arm 4b: Tebentafusp IV Monotherapy
    Number of subjects analysed
    38
    13
    28
    20
    6
    Units: Percentage of participants
        number (confidence interval 90%)
    11.6 (4.7 to 22.9)
    0 (0 to 20.6)
    13.8 (4.9 to 28.8)
    0 (0 to 13.9)
    0 (0 to 34.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 up to 90 days post-treatment
    Adverse event reporting additional description
    All treated participants are included. The summary row for nonserious AEs shows the number of participants with any AE. Only events meeting >5% cutoff are presented.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Arm 1: Tebentafusp + Durvalumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with durvalumab(MEDI4736)

    Reporting group title
    Arm 2: Tebentafusp + Tremelimumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with tremelimumab

    Reporting group title
    Arm 3: Tebentafusp + Durvalumab + Tremelimumab
    Reporting group description
    		 IV Tebentafusp (IMCgp100) with durvalumab (MEDI4736) and tremelimumab

    Reporting group title
    Arm 4a: Tebentafusp IV Monotherapy
    Reporting group description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion once weekly

    Reporting group title
    Arm 4b: Tebentafusp IV Monotherapy
    Reporting group description
    		 Tebentafusp (IMCgp100) (single agent) IV infusion 3 times weekly

    Serious adverse events
    		 Arm 1: Tebentafusp + Durvalumab Arm 2: Tebentafusp + Tremelimumab Arm 3: Tebentafusp + Durvalumab + Tremelimumab Arm 4a: Tebentafusp IV Monotherapy Arm 4b: Tebentafusp IV Monotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 43 (39.53%)
    3 / 13 (23.08%)
    11 / 29 (37.93%)
    11 / 20 (55.00%)
    4 / 7 (57.14%)
         number of deaths (all causes)
    31
    8
    18
    13
    6
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to spine
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic ocular melanoma
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Pyrexia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 13 (15.38%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    1 / 20 (5.00%)
    0 / 7 (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
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst torsion
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Vaccination complication
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequent bowel movements
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 13 (15.38%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash macular
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash papular
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    		 Arm 1: Tebentafusp + Durvalumab Arm 2: Tebentafusp + Tremelimumab Arm 3: Tebentafusp + Durvalumab + Tremelimumab Arm 4a: Tebentafusp IV Monotherapy Arm 4b: Tebentafusp IV Monotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 43 (100.00%)
    13 / 13 (100.00%)
    29 / 29 (100.00%)
    20 / 20 (100.00%)
    7 / 7 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastrointestinal melanoma
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 43 (11.63%)
    2 / 13 (15.38%)
    3 / 29 (10.34%)
    3 / 20 (15.00%)
    3 / 7 (42.86%)
         occurrences all number
    7
    2
    5
    5
    3
    Hypertension
         subjects affected / exposed
    5 / 43 (11.63%)
    1 / 13 (7.69%)
    3 / 29 (10.34%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    18
    1
    5
    2
    0
    Flushing
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 13 (0.00%)
    3 / 29 (10.34%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    4
    2
    0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    1
    Lymphodema
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Embolism
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Haemorrhage
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    24 / 43 (55.81%)
    6 / 13 (46.15%)
    15 / 29 (51.72%)
    10 / 20 (50.00%)
    3 / 7 (42.86%)
         occurrences all number
    50
    13
    50
    18
    4
    Fatigue
         subjects affected / exposed
    24 / 43 (55.81%)
    4 / 13 (30.77%)
    14 / 29 (48.28%)
    9 / 20 (45.00%)
    0 / 7 (0.00%)
         occurrences all number
    30
    4
    16
    10
    0
    Chills
         subjects affected / exposed
    11 / 43 (25.58%)
    3 / 13 (23.08%)
    5 / 29 (17.24%)
    4 / 20 (20.00%)
    2 / 7 (28.57%)
         occurrences all number
    21
    5
    12
    7
    2
    Oedema peripheral
         subjects affected / exposed
    10 / 43 (23.26%)
    4 / 13 (30.77%)
    6 / 29 (20.69%)
    2 / 20 (10.00%)
    1 / 7 (14.29%)
         occurrences all number
    12
    5
    8
    2
    2
    Face odema
         subjects affected / exposed
    8 / 43 (18.60%)
    2 / 13 (15.38%)
    2 / 29 (6.90%)
    5 / 20 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    12
    2
    2
    6
    0
    Influenza like illness
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 13 (7.69%)
    3 / 29 (10.34%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    9
    1
    3
    1
    1
    Peripheral swelling
         subjects affected / exposed
    5 / 43 (11.63%)
    3 / 13 (23.08%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    4
    2
    0
    0
    Generalised oedema
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    3 / 20 (15.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    2
    4
    2
    Pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Chest pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Multiple organ dysfunction
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    3
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 13 (15.38%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Genital parasthesia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Pruritus genital
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Scrotal pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 43 (16.28%)
    4 / 13 (30.77%)
    9 / 29 (31.03%)
    3 / 20 (15.00%)
    0 / 7 (0.00%)
         occurrences all number
    8
    5
    10
    3
    0
    Dyspnoea
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 13 (15.38%)
    3 / 29 (10.34%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    2
    3
    4
    0
    Pleural effusion
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    3
    0
    2
    1
    1
    Nasal congestion
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    4 / 29 (13.79%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    4
    0
    0
    Rhinorrhea
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 13 (7.69%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    1
    2
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    2
    0
    0
    Epistaxis
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    4
    0
    0
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Pneumonitis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Haemoptysis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    2
    2
    0
    Depression
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 13 (15.38%)
    0 / 29 (0.00%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    0
    2
    0
    Confusional state
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Mental status changes
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 43 (11.63%)
    1 / 13 (7.69%)
    6 / 29 (20.69%)
    2 / 20 (10.00%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    8
    4
    1
    Lipase increased
         subjects affected / exposed
    7 / 43 (16.28%)
    1 / 13 (7.69%)
    7 / 29 (24.14%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    14
    2
    11
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 43 (13.95%)
    1 / 13 (7.69%)
    4 / 29 (13.79%)
    2 / 20 (10.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    1
    4
    4
    1
    Blood alklaline phosphatase incrased
         subjects affected / exposed
    6 / 43 (13.95%)
    1 / 13 (7.69%)
    5 / 29 (17.24%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    8
    1
    8
    3
    0
    Amylase increased
         subjects affected / exposed
    6 / 43 (13.95%)
    0 / 13 (0.00%)
    3 / 29 (10.34%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    21
    0
    5
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    8
    0
    2
    0
    1
    Weight decreased
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    2
    2
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    Weight increased
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Sunburn
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    0
    1
    Radiation skin injury
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 13 (0.00%)
    4 / 29 (13.79%)
    3 / 20 (15.00%)
    1 / 7 (14.29%)
         occurrences all number
    9
    0
    6
    3
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    0
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 43 (13.95%)
    2 / 13 (15.38%)
    4 / 29 (13.79%)
    7 / 20 (35.00%)
    2 / 7 (28.57%)
         occurrences all number
    6
    8
    5
    11
    3
    Dizziness
         subjects affected / exposed
    5 / 43 (11.63%)
    2 / 13 (15.38%)
    3 / 29 (10.34%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    5
    3
    3
    2
    0
    Paraesthesia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    0
    0
    1
    2
    Dysarthria
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Syncope
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    4 / 20 (20.00%)
    2 / 7 (28.57%)
         occurrences all number
    5
    0
    1
    9
    3
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    10 / 43 (23.26%)
    2 / 13 (15.38%)
    7 / 29 (24.14%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    14
    3
    10
    1
    1
    Vision blurred
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    2
    0
    1
    0
    1
    Photophobia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    16 / 43 (37.21%)
    2 / 13 (15.38%)
    12 / 29 (41.38%)
    9 / 20 (45.00%)
    1 / 7 (14.29%)
         occurrences all number
    23
    2
    19
    16
    1
    Diarrhoea
         subjects affected / exposed
    10 / 43 (23.26%)
    4 / 13 (30.77%)
    14 / 29 (48.28%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    15
    5
    19
    2
    0
    Vomiting
         subjects affected / exposed
    14 / 43 (32.56%)
    1 / 13 (7.69%)
    9 / 29 (31.03%)
    6 / 20 (30.00%)
    0 / 7 (0.00%)
         occurrences all number
    23
    1
    14
    7
    0
    Abdominal pain
         subjects affected / exposed
    9 / 43 (20.93%)
    1 / 13 (7.69%)
    5 / 29 (17.24%)
    7 / 20 (35.00%)
    0 / 7 (0.00%)
         occurrences all number
    13
    1
    6
    11
    0
    Constipation
         subjects affected / exposed
    7 / 43 (16.28%)
    3 / 13 (23.08%)
    4 / 29 (13.79%)
    4 / 20 (20.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    3
    5
    5
    1
    Dyspepsia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    2
    2
    0
    Dysphagia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    1
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    6
    2
    0
    Gastrooesophogeal reflux disease
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Gastritis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Toothache
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Colitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    Small intestinal perforation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    30 / 43 (69.77%)
    7 / 13 (53.85%)
    24 / 29 (82.76%)
    16 / 20 (80.00%)
    6 / 7 (85.71%)
         occurrences all number
    68
    31
    76
    58
    17
    Pruritus
         subjects affected / exposed
    29 / 43 (67.44%)
    8 / 13 (61.54%)
    17 / 29 (58.62%)
    14 / 20 (70.00%)
    4 / 7 (57.14%)
         occurrences all number
    62
    31
    40
    30
    5
    Dry skin
         subjects affected / exposed
    13 / 43 (30.23%)
    4 / 13 (30.77%)
    4 / 29 (13.79%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    15
    4
    4
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    13 / 43 (30.23%)
    3 / 13 (23.08%)
    3 / 29 (10.34%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    22
    6
    14
    0
    0
    Hair colour changes
         subjects affected / exposed
    7 / 43 (16.28%)
    0 / 13 (0.00%)
    7 / 29 (24.14%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    7
    0
    7
    2
    0
    Vitiligo
         subjects affected / exposed
    8 / 43 (18.60%)
    2 / 13 (15.38%)
    5 / 29 (17.24%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    8
    2
    5
    1
    0
    Erythema
         subjects affected / exposed
    7 / 43 (16.28%)
    0 / 13 (0.00%)
    6 / 29 (20.69%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    15
    0
    9
    2
    0
    Skin exfoliation
         subjects affected / exposed
    9 / 43 (20.93%)
    1 / 13 (7.69%)
    4 / 29 (13.79%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    12
    2
    4
    0
    0
    Alopecia
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    2
    1
    0
    Skin hyperpigmentation
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    2
    1
    0
    Skin hypopigmentation
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    3 / 29 (10.34%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    4
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    Rash macular
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Dermatitis bullous
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 13 (15.38%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    Skin fissures
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Eczema
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    0
    1
    Xeroderma
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Palmar-plantar erythrodysaesthesia syndrom
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    3 / 29 (10.34%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    4 / 29 (13.79%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    Adrenal insufficiency
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 43 (18.60%)
    1 / 13 (7.69%)
    10 / 29 (34.48%)
    3 / 20 (15.00%)
    1 / 7 (14.29%)
         occurrences all number
    12
    1
    15
    3
    1
    Pain in extremity
         subjects affected / exposed
    9 / 43 (20.93%)
    3 / 13 (23.08%)
    4 / 29 (13.79%)
    2 / 20 (10.00%)
    1 / 7 (14.29%)
         occurrences all number
    14
    3
    4
    2
    2
    Back pain
         subjects affected / exposed
    8 / 43 (18.60%)
    1 / 13 (7.69%)
    5 / 29 (17.24%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    10
    1
    8
    2
    0
    Myalgia
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 13 (7.69%)
    5 / 29 (17.24%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    6
    1
    5
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    3
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    0
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 13 (15.38%)
    4 / 29 (13.79%)
    2 / 20 (10.00%)
    1 / 7 (14.29%)
         occurrences all number
    5
    2
    5
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    8
    0
    3
    7
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    3 / 29 (10.34%)
    2 / 20 (10.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    3
    4
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 13 (7.69%)
    3 / 29 (10.34%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    3
    1
    0
    Sinusitis
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    Infection
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    0
    1
    Herpes simplex
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Paronchyia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 43 (25.58%)
    2 / 13 (15.38%)
    5 / 29 (17.24%)
    3 / 20 (15.00%)
    0 / 7 (0.00%)
         occurrences all number
    13
    2
    5
    3
    0
    Hyponatraemia
         subjects affected / exposed
    5 / 43 (11.63%)
    1 / 13 (7.69%)
    2 / 29 (6.90%)
    3 / 20 (15.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    1
    2
    6
    1
    Hypophosphataemia
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    1 / 20 (5.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    0
    5
    1
    3
    Hypomagnesaemia
         subjects affected / exposed
    6 / 43 (13.95%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    9
    0
    3
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    9
    1
    3
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 13 (7.69%)
    1 / 29 (3.45%)
    2 / 20 (10.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    2
    2
    3
    Hyperglycaemia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 13 (0.00%)
    1 / 29 (3.45%)
    0 / 20 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    2
    0
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 13 (15.38%)
    0 / 29 (0.00%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 13 (0.00%)
    2 / 29 (6.90%)
    0 / 20 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Hypokalaemia
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 13 (0.00%)
    3 / 29 (10.34%)
    1 / 20 (5.00%)
    0 / 7 (0.00%)
         occurrences all number
    12
    0
    5
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2015
    AM1: The primary purpose of the amendment was to modify the dosing regimen and DLT criteria.
    31 Mar 2016
    AM2: The primary purpose of the amendment was to modify the intra-patient dosing regimen.
    03 Mar 2017
    AM3: The primary purpose was to modify enrollment criteria.
    29 Jun 2017
    AM4: The primary purpose was to update nomenclature of dose levels and of the recommended Phase 2 dose (RP2D).
    26 Oct 2017
    AM5: The primary purpose was to clarify recommended toxicity management and dose modification guidance.
    18 Jun 2018
    AM6: The primary purpose was to further update recommended toxicity management and dose modification.
    22 Jan 2019
    AM7: The primary purpose was to optimize IMCgp100 monotherapy.
    29 Jan 2019
    AM8: The primary purpose was to update toxicity management guidelines for Grade 3 and 4 non-immune mediated reactions.
    24 Dec 2021
    AM9: The primary purpose was to modify dose escalation of SC IMGgp100 (US only).

    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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