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    Clinical Trial Results:
    An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies

    Summary
    EudraCT number
    		 2021-002037-42
    Trial protocol
    		 DE   SE   FR  
    Global end of trial date
    24 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2025
    First version publication date
    28 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C5771001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04993677
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Seagen Inc.
    Sponsor organisation address
    21823 30th Drive S.E., Bothell, United States, 98021
    Public contact
    Chief Medical Officer, Seagen Inc., 1 8554732436, medinfo@seagen.com
    Scientific contact
    Chief Medical Officer, Seagen Inc., 1 8554732436, medinfo@seagen.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
    11 Feb 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the antitumor activity of SEA-CD40 combined with other therapies.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 60
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Canada: 1
    Worldwide total number of subjects
    77
    EEA total number of subjects
    16
    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)
    39
    From 65 to 84 years
    36
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study planned to have 5 cohorts-Cohort 1: relapsed/refractory melanoma, Cohort 2: uveal melanoma, Cohort 3: programmed cell death 1 ligand 1 (PD-[L]1)-naive melanoma, Cohort 4: non-small cell lung cancer (NSCLC), programmed cell death ligand 1 (PD-L1) 1-49%, Cohort 5: NSCLC, PD-L1 < 1%. No participant was enrolled and treated in Cohort 3.

    Pre-assignment
    Screening details
    		 “Study termination by sponsor” was used as the end of study reason after long-term follow-up was discontinued and enrollment closed. Study status is “completed” as participants received treatment per protocol, followed by safety follow-up. No further disease or survival follow-up was required.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Relapsed/refractory melanoma
    Arm description
    		 Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 milligrams (mg) as an IV infusion on Day 8 of 42-day cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.

    Investigational medicinal product name
    SEA-CD40
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles.

    Arm title
    		 Cohort 2: Uveal melanoma
    Arm description
    		 Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.

    Investigational medicinal product name
    SEA-CD40
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles.

    Arm title
    		 Cohort 4: NSCLC, PD-L1 1-49%
    Arm description
    		 Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg per meter square (/m^2) as an IV infusion on Day 1 of 21-day cycles and Carboplatin area under curve (AUC) 5 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of 21-day (Cycles 1–4).
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEA-CD40
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles.

    Investigational medicinal product name
    Carboplatin AUC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles.

    Arm title
    		 Cohort 5: NSCLC, PD-L1 < 1%
    Arm description
    		 Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEA-CD40
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles.

    Investigational medicinal product name
    Carboplatin AUC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles.

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles.

    Number of subjects in period 1
    		Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Started
    21
    39
    9
    8
    Completed
    0
    0
    0
    0
    Not completed
    21
    39
    9
    8
         Consent withdrawn by subject
    4
    3
    -
    2
         Unspecified
    2
    3
    3
    2
         Adverse Events
    11
    8
    3
    1
         Study termination by sponsor
    3
    25
    3
    3
         Lost to follow-up
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Relapsed/refractory melanoma
    Reporting group description
    		 Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 milligrams (mg) as an IV infusion on Day 8 of 42-day cycles.

    Reporting group title
    Cohort 2: Uveal melanoma
    Reporting group description
    		 Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.

    Reporting group title
    Cohort 4: NSCLC, PD-L1 1-49%
    Reporting group description
    		 Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg per meter square (/m^2) as an IV infusion on Day 1 of 21-day cycles and Carboplatin area under curve (AUC) 5 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Reporting group title
    Cohort 5: NSCLC, PD-L1 < 1%
    Reporting group description
    		 Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Reporting group values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1% Total
    Number of subjects
    		 21 39 9 8
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.3 ( 11.6 ) 62.2 ( 12.4 ) 64.6 ( 9.2 ) 66.8 ( 9.5 ) -
    Gender categorical
    Units: Subjects
        Male
    		 12 19 5 6 42
        Female
    		 9 20 4 2 35
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 0 0 1 4
        Not Hispanic or Latino
    		 16 38 9 5 68
        Unknown or Not Reported
    		 2 1 0 2 5
    Race
    Units: Subjects
        Asian
    		 1 0 0 0 1
        Black or African American
    		 0 0 0 1 1
        White
    		 16 39 9 5 69
        Unknown or Not Reported
    		 4 0 0 2 6

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Relapsed/refractory melanoma
    Reporting group description
    		 Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 milligrams (mg) as an IV infusion on Day 8 of 42-day cycles.

    Reporting group title
    Cohort 2: Uveal melanoma
    Reporting group description
    		 Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.

    Reporting group title
    Cohort 4: NSCLC, PD-L1 1-49%
    Reporting group description
    		 Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg per meter square (/m^2) as an IV infusion on Day 1 of 21-day cycles and Carboplatin area under curve (AUC) 5 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Reporting group title
    Cohort 5: NSCLC, PD-L1 < 1%
    Reporting group description
    		 Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Primary: Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) per Investigator Assessment

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    End point title
    		 Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) per Investigator Assessment [1]
    End point description
    cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. The response evaluable (RE) analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment. 99999 indicated that the upper and lower limit of 95% CI was not estimable since no participant had event.
    End point type
    Primary
    End point timeframe
    From start of study treatment until CR or PR (maximum up to 15.2 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: Only descriptive data was planned for this endpoint.
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (-99999 to 99999)
    5 (0.6 to 17.3)
    44 (13.7 to 78.8)
    25 (3.2 to 65.1)
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE
    End point description
    AE: untoward medical occurrence in participant administered medicinal product which doesn’t necessarily have causal relationship with treatment. SAE: any AE that at any dose resulted in death, life threatening, required hospitalization/prolongation of hospitalisation, disabling/incapacitating, congenital anomaly/birth defects. AEs included SAEs,non-SAEs. TEAEs:newly occurring/worsening after 1st dose of treatment. Treatment related TEAEs: related to treatment; relatedness judged by investigator. TEAEs graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threating, grade 5=fatal). TESAEs:any TEAE that at any dose suspected to cause death, life-threatening, required hospitalisation, disabling/incapacitating, congenital anomaly/birth defect. Treatment related TESAEs:related to treatment; relatedness judged by investigator. Safety analysis set: participants who received study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of the study treatment (Day 1) up to approximately 18.5 months
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Participants
        TEAE
    17
    37
    8
    8
        Treatment-related TEAE
    16
    32
    8
    8
        >= Grade 3 TEAEs
    7
    7
    7
    6
        TESAE
    4
    5
    5
    5
        Treatment-related TESAE
    2
    2
    3
    3
    No statistical analyses for this end point

    Secondary: Number of Participants With Grade Shift from Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE

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    End point title
    		 Number of Participants With Grade Shift from Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE
    End point description
    Number of participants with baseline (BL) laboratory values as per NCI-CTCAE grade (G) (grade 0=within normal limits, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening) and corresponding changes/shift to worst maximum (max) CTC grades post baseline presented. Laboratory parameters evaluated: alanine aminotransferase (AAT) increased, albumin decreased, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, calcium corrected for albumin (CCA), creatinine increased, glomerular filtration rate (GFR) estimated decreased, glucose decreased, lactate dehydrogenase (LD) increased, potassium, sodium, total bilirubin (TB) increased. Baseline: last non-missing grade before 1st dose of study treatment. Worst post-baseline value: worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. Safety analysis set included participants who received study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 15.8 months
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Participants
        AAT-increased: BL Grade 0 to max post-BL Grade 1
    2
    7
    3
    3
        AAT - increased: BL G0 to max post-BL G2
    0
    3
    1
    0
        AAT - increased: BL G0 to max post-BL G3
    0
    1
    0
    0
        AAT - increased: BL G1 to max post-BL G0
    0
    1
    0
    0
        AAT - increased: BL G2 to max post-BL G0
    0
    1
    0
    0
        Albumin-decreased: BL G0 to max post-BL G1
    5
    2
    2
    1
        Albumin-decreased: BL G0 to max post-BL G2
    1
    0
    1
    1
        Albumin-decreased: BL G1 to max post-BL G2
    3
    1
    1
    1
        ALP - increased: BL G0 to max post-BL G1
    4
    9
    1
    1
        ALP - increased: BL G1 to max post-BL G0
    1
    3
    1
    2
        ALP - increased: BL G1 to max post-BL G2
    1
    0
    0
    0
        ALP - increased: BL G2 to max post-BL G0
    0
    0
    1
    0
        AST - increased: BL G0 to max post-BL Grade 1
    5
    14
    3
    4
        AST - increased: BL G0 to max post-BL G2
    1
    2
    1
    0
        AST - increased: BL G1 to max post-BL G0
    0
    2
    0
    0
        AST - increased: BL G1 to max post-BL G2
    0
    1
    0
    0
        CCA - decreased: BL G0 to max post-BL G1
    2
    1
    4
    1
        CCA - decreased: BL G0 to max post-BL G2
    0
    0
    1
    2
        CCA - decreased: BL G2 to max post-BL Grade 1
    0
    1
    0
    0
        CCA - increased: BL G0 to max post-BL G1
    0
    9
    0
    0
        Creatinine - increased: BL G0 to max post-BL G1
    3
    5
    1
    2
        Creatinine-increased: BL G0 to max post-BL G2
    1
    2
    0
    0
        Creatinine-increased: BL G0 to max post-BL G3
    0
    0
    0
    1
        Creatinine-increased: BL G1 to max post-BL G2
    0
    1
    0
    0
        Glucose-decreased: BL G0 to post-BL G1
    0
    3
    0
    2
        LD - increased: BL G0 to max post-BL G1
    3
    22
    3
    4
        LD - increased: BL G1 to max post-BL G0
    1
    0
    0
    0
        Potassium-decreased: BL G0 to max post-BL G1
    3
    4
    2
    1
        Potassium-decreased: BL G0 to max post-BL G3
    0
    0
    0
    1
        Potassium-decreased: BL G1 to max post-BL G0
    0
    1
    1
    0
        Potassium-increased: BL G0 to max post-BL G1
    1
    4
    0
    1
        Potassium-increased: BL G0 to max post-BL G2
    0
    4
    1
    1
        Sodium - decreased: BL G0 to max post-BL G1
    7
    10
    3
    3
        Sodium - decreased: BL G0 to max post-BL G2
    1
    2
    0
    1
        Sodium - decreased: BL G0 to max post-BL G3
    0
    1
    0
    0
        Sodium - decreased: BL G1 to max post-BL G0
    0
    1
    1
    0
        Sodium - decreased: BL G1 to max post-BL G2
    0
    1
    0
    0
        TB - increased: BL G0 to max post-BL G1
    1
    2
    0
    0
        TB - increased: BL G0 to max post-BL G3
    1
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Grade Shift from Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE

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    End point title
    		 Number of Participants With Grade Shift from Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE
    End point description
    In this endpoint, number of participants with baseline laboratory hematology values as per NCI-CTCAE grade (grade 0= within normal limits, grade 1=mild, grade 2=moderate, grade 3= severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: hemoglobin (Hb)- decreased and increased, leukocytes- decreased and increased, lymphocytes- decreased and increased, neutrophils decreased, platelets decreased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. The safety analysis set included all participants who received any amount of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 15.8 months
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Participants
        Hb - decreased: BL G0 to max post-BL G1
    7
    11
    4
    2
        Hb - decreased: BL G0 to max post-BL G2
    0
    0
    2
    1
        Hb - decreased: BL G0 to max post-BL G3
    0
    0
    1
    1
        Hb - decreased: BL G1 to max post-BL G2
    3
    1
    0
    3
        Hb - decreased: BL G1 to max post-BL G3
    1
    0
    1
    1
        Hb - decreased: BL G2 to max post-BL G1
    0
    1
    0
    0
        Hb - increased: BL G0 to max post-BL G1
    0
    2
    0
    0
        Leukocytes-decreased: BL G0 to max post-BL G1
    1
    3
    2
    4
        Leukocytes-decreased: BL G0 to max post-BL G2
    0
    0
    1
    0
        Leukocytes-decreased: BL G0 to max post-BL G3
    0
    0
    1
    0
        Lymphocytes-decreased: BL G0 to post-BL G1
    2
    9
    1
    1
        Lymphocytes-decreased: BL G0 to max post-BL G2
    4
    0
    2
    0
        Lymphocytes-decreased: BL G0 to max post-BL G3
    1
    1
    1
    0
        Lymphocytes-decreased: BL G0 to max post-BL G4
    0
    0
    1
    0
        Lymphocytes-decreased: BL G1 to max post-BL G2
    1
    1
    0
    1
        Lymphocytes-decreased: BL G1 to max post-BL G3
    0
    0
    0
    1
        Lymphocytes-decreased: BL G2 to max post-BL G3
    0
    2
    1
    0
        Lymphocytes-decreased: BL G3 to max post-BL G4
    0
    0
    0
    1
        Lymphocytes-increased: BL G0 to max post-BL G2
    0
    1
    0
    0
        Neutrophils-decreased: BL G0 to max post-BL G1
    1
    2
    0
    0
        Neutrophils-decreased: BL G0 to max post-BL G2
    0
    0
    2
    1
        Neutrophils-decreased: BL G0 to max post-BL G3
    0
    0
    1
    0
        Platelets-decreased: BL G0 to max post-BL G1
    1
    1
    4
    3
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations due to Adverse Events

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    End point title
    		 Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations due to Adverse Events
    End point description
    An AE is defined as any untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn’t necessarily have causal relationship with treatment. Number of participants with dose interruption (SEA-CD40 treatment being temporarily stopped), dose reduction (SEA-CD40 decrease in dose) and dose discontinuation (SEA-CD40 treatment permanently stopped) due to adverse events were reported in this outcome measure. The safety analysis set included all participants who received any amount of study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of the study treatment (Day 1) up to approximately 18.5 months
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Participants
        Treatment interruptions
    1
    5
    2
    1
        Dose reductions
    0
    0
    0
    0
        Treatment discontinuations
    2
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) per Investigator Assessment

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    End point title
    		 Disease Control Rate (DCR) per Investigator Assessment
    End point description
    DCR is defined as the percentage of participants who achieved a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or met the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for progressive disease (PD) referring smallest sum diameter, PD: at least 20% increase (including absolute increase of at least 5 mm) in sum of diameters of target lesions, taking reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. RE analysis set was analysed.
    End point type
    Secondary
    End point timeframe
    From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 23.6 months)
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Percentage of participants
        number (confidence interval 95%)
    48 (25.7 to 70.2)
    62 (44.6 to 76.6)
    67 (29.9 to 92.5)
    88 (47.3 to 99.7)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) per Investigator Assessment

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    End point title
    		 Duration of Response (DOR) per Investigator Assessment
    End point description
    DOR:time from 1st documentation of OR(confirmed CR/PR)to 1st documentation of PD/death,whichever occurred 1st.Per RECIST v1.1,CR: disappearance of target lesions.Pathological lymph nodes must have reduction in short axis to <10mm.PR:>=30% decrease in sum of diameters of target lesions.Participants with no PD,still on study at time of analysis/removed from study prior to PD documentation censored at last disease assessment documenting absence of PD.Participants starting anticancer treatment prior to PD documentation censored at last disease assessment prior to treatment.PD:>=20% increase in sum of diameters of target lesions,with 0.5cm increase.Appearance of 1+ new lesions.Kaplan-Meier method.RE analysis set.Subjects Analyzed=participants with confirmed CR/PR. 77777:median, upper limit (UL) 95%CI not estimable due to less number of participants. 88888:UL 95%CI not estimable due to less number of participants. 99999:lower and UL of 95%CI not estimable due to less number of participants.
    End point type
    Secondary
    End point timeframe
    From the first documentation of CR or PR to PD or death due to any cause or censoring, whichever occurred first (maximum up to 23.6 months)
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    0 [2]
    2
    4
    2
    Units: Months
        median (confidence interval 95%)
    ( to )
    77777 (5.6 to 77777)
    11.1 (9.9 to 88888)
    2.1 (-99999 to 99999)
    Notes
    [2] - No participant had an event.
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) per Investigator Assessment

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    End point title
    		 Progression Free Survival (PFS) per Investigator Assessment
    End point description
    PFS: time from start of study treatment to first documentation of PD by RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PD and were still on study at time of analysis/were removed from study prior to documentation of PD were censored at date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5cm. Appearance of one or more new lesions was also considered progression. Kaplan-Meier method used. Full analysis set (FAS) included participants who received study drug. 88888: upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment to the date of PD or death due to any cause or censoring, whichever occurred first (maximum up to 23.6 months)
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Months
        median (confidence interval 95%)
    1.6 (1.4 to 2.9)
    4.0 (1.4 to 8.2)
    13.8 (1.4 to 88888)
    5.5 (1.4 to 88888)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from the start of study treatment to date of death due to any cause. In the absence of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for analysis. The FAS included all participants who received any amount of study drug. 77777: Median and upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events. 88888: Upper limit of the 95% confidence interval was not estimable due to insufficient number of participants with events.
    End point type
    Secondary
    End point timeframe
    From start of study treatment to death due to any cause or censoring, (maximum up to 23.6 months)
    End point values
    		 Cohort 1: Relapsed/refractory melanoma Cohort 2: Uveal melanoma Cohort 4: NSCLC, PD-L1 1-49% Cohort 5: NSCLC, PD-L1 < 1%
    Number of subjects analysed
    21
    39
    9
    8
    Units: Months
        median (confidence interval 95%)
    11.0 (5.3 to 18.7)
    77777 (16.7 to 77777)
    18.0 (2.5 to 88888)
    77777 (3.2 to 77777)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of the study treatment (Day 1) up to approximately 18.5 months for SAEs, 16.5 months for non-SAEs and 23.6 months for death
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorised as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. The safety analysis set included all participants who received any amount of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cohort 1: Relapsed/refractory melanoma
    Reporting group description
    		 Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.

    Reporting group title
    Cohort 5: NSCLC, PD-L1 < 1%
    Reporting group description
    		 Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Reporting group title
    Cohort 4: NSCLC, PD-L1 1-49%
    Reporting group description
    		 Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1–4).

    Reporting group title
    Cohort 2: Uveal melanoma
    Reporting group description
    		 Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles.

    Serious adverse events
    		 Cohort 1: Relapsed/refractory melanoma Cohort 5: NSCLC, PD-L1 < 1% Cohort 4: NSCLC, PD-L1 1-49% Cohort 2: Uveal melanoma
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 21 (19.05%)
    5 / 8 (62.50%)
    5 / 9 (55.56%)
    5 / 39 (12.82%)
         number of deaths (all causes)
    11
    1
    3
    8
         number of deaths resulting from adverse events
    1
    1
    1
    0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune-mediated enterocolitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypophysitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Relapsed/refractory melanoma Cohort 5: NSCLC, PD-L1 < 1% Cohort 4: NSCLC, PD-L1 1-49% Cohort 2: Uveal melanoma
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 21 (80.95%)
    7 / 8 (87.50%)
    8 / 9 (88.89%)
    37 / 39 (94.87%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    1
    0
    0
    5
    Hot flush
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    4 / 39 (10.26%)
         occurrences all number
    1
    0
    3
    4
    Hypertension
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    3
    0
    0
    2
    Hypotension
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 8 (25.00%)
    2 / 9 (22.22%)
    3 / 39 (7.69%)
         occurrences all number
    6
    3
    2
    3
    Phlebitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Chills
         subjects affected / exposed
    6 / 21 (28.57%)
    3 / 8 (37.50%)
    2 / 9 (22.22%)
    11 / 39 (28.21%)
         occurrences all number
    8
    4
    4
    16
    Chest pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 8 (37.50%)
    7 / 9 (77.78%)
    24 / 39 (61.54%)
         occurrences all number
    5
    4
    9
    32
    Pyrexia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    5 / 39 (12.82%)
         occurrences all number
    2
    0
    1
    5
    Oedema peripheral
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    5
    1
    0
    3
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    0
    0
    3
    Reproductive system and breast disorders
    Vulvovaginal rash
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 8 (37.50%)
    3 / 9 (33.33%)
    4 / 39 (10.26%)
         occurrences all number
    2
    4
    3
    4
    Dysphonia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Cough
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 8 (37.50%)
    1 / 9 (11.11%)
    8 / 39 (20.51%)
         occurrences all number
    2
    3
    1
    9
    Epistaxis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoxia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 39 (10.26%)
         occurrences all number
    0
    0
    0
    4
    Oropharyngeal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    1
    Productive cough
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    0
    2
    Pulmonary embolism
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 39 (10.26%)
         occurrences all number
    1
    0
    0
    4
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Confusional state
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    0
    1
    Depression
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    0
    1
    Insomnia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 39 (5.13%)
         occurrences all number
    2
    0
    1
    2
    Irritability
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 8 (25.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    5
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    3 / 39 (7.69%)
         occurrences all number
    0
    1
    4
    5
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    6 / 39 (15.38%)
         occurrences all number
    0
    2
    6
    8
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    3
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    2 / 39 (5.13%)
         occurrences all number
    0
    1
    1
    2
    Procedural pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infusion related reaction
         subjects affected / exposed
    12 / 21 (57.14%)
    4 / 8 (50.00%)
    3 / 9 (33.33%)
    11 / 39 (28.21%)
         occurrences all number
    17
    5
    6
    23
    Fall
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    1
    Skull fractured base
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Balance disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Memory impairment
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    4 / 39 (10.26%)
         occurrences all number
    0
    0
    2
    4
    Headache
         subjects affected / exposed
    4 / 21 (19.05%)
    2 / 8 (25.00%)
    4 / 9 (44.44%)
    13 / 39 (33.33%)
         occurrences all number
    5
    3
    4
    18
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    5 / 39 (12.82%)
         occurrences all number
    2
    1
    5
    5
    Syncope
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Radiculopathy
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 21 (14.29%)
    6 / 8 (75.00%)
    4 / 9 (44.44%)
    3 / 39 (7.69%)
         occurrences all number
    3
    9
    6
    3
    Neutropenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    5
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    1
    Hypoacusis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Visual impairment
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    8 / 39 (20.51%)
         occurrences all number
    3
    0
    0
    10
    Abdominal pain upper
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    3
    Constipation
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 8 (37.50%)
    1 / 9 (11.11%)
    15 / 39 (38.46%)
         occurrences all number
    3
    3
    2
    16
    Diarrhoea
         subjects affected / exposed
    6 / 21 (28.57%)
    3 / 8 (37.50%)
    3 / 9 (33.33%)
    9 / 39 (23.08%)
         occurrences all number
    9
    3
    5
    10
    Defaecation urgency
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    5 / 39 (12.82%)
         occurrences all number
    0
    0
    1
    5
    Eructation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 8 (12.50%)
    2 / 9 (22.22%)
    2 / 39 (5.13%)
         occurrences all number
    2
    1
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune-mediated enterocolitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    9 / 21 (42.86%)
    3 / 8 (37.50%)
    7 / 9 (77.78%)
    16 / 39 (41.03%)
         occurrences all number
    15
    3
    9
    28
    Stomatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    2 / 9 (22.22%)
    1 / 39 (2.56%)
         occurrences all number
    0
    2
    2
    1
    Vomiting
         subjects affected / exposed
    6 / 21 (28.57%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    3 / 39 (7.69%)
         occurrences all number
    8
    1
    1
    4
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    0
    0
    5
    Erythema
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain of skin
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 8 (37.50%)
    1 / 9 (11.11%)
    5 / 39 (12.82%)
         occurrences all number
    2
    3
    1
    5
    Pruritus
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    7 / 39 (17.95%)
         occurrences all number
    3
    0
    2
    7
    Skin haemorrhage
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 39 (5.13%)
         occurrences all number
    1
    0
    1
    2
    Urinary retention
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    2
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    6 / 39 (15.38%)
         occurrences all number
    1
    1
    0
    6
    Hyperthyroidism
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    6 / 39 (15.38%)
         occurrences all number
    5
    0
    2
    6
    Pain in extremity
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    6 / 39 (15.38%)
         occurrences all number
    0
    3
    1
    10
    Arthralgia
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    4
    1
    0
    3
    Back pain
         subjects affected / exposed
    6 / 21 (28.57%)
    3 / 8 (37.50%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    7
    3
    0
    3
    Muscular weakness
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    1
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    2 / 9 (22.22%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Rash pustular
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    3
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    1
    0
    3
    Suspected COVID-19
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    1
    Rhinitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    1
    0
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    7 / 39 (17.95%)
         occurrences all number
    2
    1
    3
    7
    Dehydration
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    4
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    4
    0
    0
    2
    Hypocalcaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    7
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 8 (25.00%)
    1 / 9 (11.11%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    1
    3
    Hyponatraemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    4
    0
    0
    4
    Hypomagnesaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Malnutrition
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2021
    Changed reporting period for all SAEs to 90 days post-last dose.
    04 Apr 2022
    Chemistry and thyroid panels were added to assessments required for the first follow-up visit. Text was updated/added to collect SAEs for 90 days after the last study treatment and or AEs will be collected through the first follow-up visit. If a subject started a new anticancer therapy, collection of SAEs that were not related to study treatment and or AEs may be stopped 30 days after the cessation of study treatment. Study treatment-related SAEs that occurred after the safety reporting period was also reported to the sponsor. New section added for management of ocular events. Changed the pregnancy reporting timeline from within 48 hours to within 24 hours of becoming aware of a pregnancy.

    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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