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    Clinical Trial Results:
    A Phase II Multicenter, Open label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M With or Without Stereotactic Body Radiation Therapy in Adults with Unresectable or Metastatic Melanoma

    Summary
    EudraCT number
    		 2018-003864-30
    Trial protocol
    		 ES   PL  
    Global end of trial date
    02 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Feb 2024
    First version publication date
    03 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    APX005M-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04337931
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pyxis Oncology, Inc.
    Sponsor organisation address
    321 Harrison Avenue, Boston, United States, MA 02118
    Public contact
    Clinical Operations, Pyxis Oncology, Inc., 1 (339) 545 8252, clinicaltrials@pyxisoncology.com
    Scientific contact
    Ken Kobayashi, Pyxis Oncology, Inc., 1 (816) 830-5408, kkobayashi@pyxisoncology.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
    02 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in each cohort.
    Protection of trial subjects
    This study was conducted in accordance with the study protocol, the ethical principles that have their origins in the Declaration of Helsinki, the International Conference on Harmonization guidelines on Good Clinical Practice, the United States Code of Federal regulations, Title 21, Part 50 (21CFR50), as well as all other applicable country and regional legal and regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jun 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Spain: 34
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    23
    From 65 to 84 years
    20
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 45 participants were enrolled in Poland and Spain between June 2019 and August 2022.

    Pre-assignment
    Screening details
    		 Forty-four participants received treatment with sotigalimab and were included in the Safety Population. One participant enrolled in Cohort 2 did not receive treatment due to withdrawal of consent and was therefore excluded from the Safety Population.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Participants received 0.3mg/kg of sotigalimab administered intravenously (IV) every 21 days (3 week) treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sotigalimab
    Investigational medicinal product code
    PYX-107
    Other name
    APX005M
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sotigalimab is a CD40 agonistic monoclonal antibody.

    Arm title
    		 Cohort 2
    Arm description
    		 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sotigalimab
    Investigational medicinal product code
    PYX-107
    Other name
    APX005M
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sotigalimab is a CD40 agonistic monoclonal antibody.

    Arm title
    		 Cohort 3 -Sotigalimab + Radiation Therapy
    Arm description
    		 Participants received 0.3 mg/kg of sotigalimab administered in combination with stereotactic body radiation therapy (SBRT) every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sotigalimab
    Investigational medicinal product code
    PYX-107
    Other name
    APX005M
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sotigalimab is a CD40 agonistic monoclonal antibody.

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Started
    12
    13
    19
    Safety Population
    12
    13
    19
    Efficacy Population
    11
    13
    19
    Completed
    0
    0
    0
    Not completed
    12
    13
    19
         Death
    4
    1
    7
         Initiation of subsequent anti-cancer treatment
    1
    -
    9
         Study terminated by sponsor
    3
    6
    2
         Initiated first treatment with anti-PD1/L1 therapy
    3
    5
    1
         Colorectal cancer treatment
    1
    -
    -
         Withdrawal by subject
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants received 0.3mg/kg of sotigalimab administered intravenously (IV) every 21 days (3 week) treatment cycle.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.

    Reporting group title
    Cohort 3 -Sotigalimab + Radiation Therapy
    Reporting group description
    		 Participants received 0.3 mg/kg of sotigalimab administered in combination with stereotactic body radiation therapy (SBRT) every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy Total
    Number of subjects
    		 12 13 19 44
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 69.00 (36.00 to 80.00)) 59.00 (40.00 to 85.00) 63.00 (30.00 to 75.00) -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 10 20
        Male
    		 8 7 9 24
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 3 0 3
        Not Hispanic or Latino
    		 12 10 19 41
        Unknown or Not Reported
    		 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 12 13 19 44
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Poland
    		 1 1 8 10
        Spain
    		 11 12 11 34
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG Performance Status determines the ability of participants to tolerate therapies in serious illness. 0= Asymptomatic (no symptoms), 1= Symptomatic (exhibits symptoms) but completely ambulatory.
    Units: Subjects
        0 (asymptomatic)
    		 7 8 7 22
        1 (symptomatic but ambulatory)
    		 5 5 12 22
    Weight
    Units: kg
        median (full range (min-max))
    		 77.20 (51.00 to 96.10) 79.00 (58.00 to 95.10) 75.00 (53.00 to 104.00) -
    Height
    Units: cm
        median (full range (min-max))
    		 169.00 (156.00 to 179.00) 166.00 (153.00 to 176.00) 168.00 (146.50 to 185.00) -

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants received 0.3mg/kg of sotigalimab administered intravenously (IV) every 21 days (3 week) treatment cycle.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.

    Reporting group title
    Cohort 3 -Sotigalimab + Radiation Therapy
    Reporting group description
    		 Participants received 0.3 mg/kg of sotigalimab administered in combination with stereotactic body radiation therapy (SBRT) every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).

    Primary: RECIST 1.1 ORR

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    End point title
    		 RECIST 1.1 ORR [1]
    End point description
    The percentage of participants having reached a confirmed Complete Response (CR) or Partial Response (PR) by RECIST 1.1, relative to the number of participants belonging to the Efficacy Population. Confidence Intervals (CIs) were calculated using exact (Clopper-Pearson) method. CR: Disappearance of all target lesions and nontarget (NT) lesions; PR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions. Participants evaluable for efficacy (tumor response) are defined as those who have measurable disease and at least one evaluable (post baseline) tumor assessment performed during the treatment period or within 30 days after the administration of the last dose of treatment.
    End point type
    Primary
    End point timeframe
    12 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analyses were pre-specified for this endpoint.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Number of subjects analysed
    11
    13
    19
    Units: percentage of participants
        number (confidence interval 90%)
    9.09 (0.47 to 36.44)
    7.69 (0.39 to 31.63)
    0.00 (0.00 to 14.59)
    No statistical analyses for this end point

    Secondary: Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)

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    End point title
    		 Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)
    End point description
    The percentage of participants having reached an immune confirmed Complete Response (iCR) or Partial Response (iPR) by iRECIST 1.1, relative to the number of participants belonging to the Efficacy Population. CIs were calculated using exact (Clopper-Pearson) method. iCR: Disappearance of all target lesions and NT lesions; iPR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions. iORR for iRECIST 1.1 by Cohort (Efficacy Population).
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Number of subjects analysed
    11
    13
    19
    Units: percentage of participants
        number (confidence interval 90%)
    9.09 (0.47 to 36.44)
    7.69 (0.39 to 31.63)
    0.00 (0.00 to 14.59)
    No statistical analyses for this end point

    Secondary: RECIST 1.1 Duration of Response (DoR)

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    End point title
    		 RECIST 1.1 Duration of Response (DoR)
    End point description
    The DoR was defined as the time (in months) from the first evidence of confirmed objective response (CR or PR) to the event or censoring date. An event was defined as the first documentation of progression disease (PD; disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method. CR: Disappearance of all target lesions and NT lesions; PR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions; PD: >20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions. Values of "99999" indicate Median and CIs were not reached due to low number of events. DoR for RECIST 1.1 by Cohort (Efficacy Population).
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Number of subjects analysed
    1 [2]
    1 [3]
    0 [4]
    Units: months
        median (confidence interval 90%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    Notes
    [2] - Inclusive of participants who experienced CR or PR only.
    [3] - Inclusive of participants who experienced CR or PR only.
    [4] - Inclusive of participants who experienced CR or PR only.
    No statistical analyses for this end point

    Other pre-specified: RECIST 1.1 Progression-free Survival (PFS)

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    End point title
    		 RECIST 1.1 Progression-free Survival (PFS)
    End point description
    The PFS was defined as the time (in months) from the first administration of APX005M to the event or censoring date. An event was defined as the first documentation of PD (disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method. PD: >20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS for RECIST 1.1 by Cohort (Efficacy Population).
    End point type
    Other pre-specified
    End point timeframe
    12 months
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Number of subjects analysed
    11
    13
    19
    Units: months
        median (confidence interval 90%)
    1.87 (1.35 to 3.71)
    3.48 (1.81 to 9.20)
    1.87 (1.64 to 1.91)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 79 weeks
    Adverse event reporting additional description
    All AE's below are reported regardless of relationship to treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycle.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.

    Reporting group title
    Cohort 3 -Sotigalimab + Radiation Therapy
    Reporting group description
    		 Participants received 0.3 mg/kg of sotigalimab administered in combination with SBRT every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).

    Serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 12 (58.33%)
    0 / 13 (0.00%)
    3 / 19 (15.79%)
         number of deaths (all causes)
    4
    1
    7
         number of deaths resulting from adverse events
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Gait disturbance
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3 -Sotigalimab + Radiation Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    12 / 13 (92.31%)
    19 / 19 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 13 (23.08%)
    1 / 19 (5.26%)
         occurrences all number
    1
    4
    1
    Flushing
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Hypotension
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 12 (33.33%)
    7 / 13 (53.85%)
    4 / 19 (21.05%)
         occurrences all number
    4
    11
    4
    Chills
         subjects affected / exposed
    2 / 12 (16.67%)
    6 / 13 (46.15%)
    5 / 19 (26.32%)
         occurrences all number
    2
    7
    6
    Pyrexia
         subjects affected / exposed
    7 / 12 (58.33%)
    7 / 13 (53.85%)
    13 / 19 (68.42%)
         occurrences all number
    17
    15
    20
    Axillary pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Malaise
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    2
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    4 / 19 (21.05%)
         occurrences all number
    1
    3
    5
    Dyspnoea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pharyngeal erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 12 (50.00%)
    6 / 13 (46.15%)
    7 / 19 (36.84%)
         occurrences all number
    13
    14
    9
    Aspartate aminotransferase increased
         subjects affected / exposed
    7 / 12 (58.33%)
    6 / 13 (46.15%)
    8 / 19 (42.11%)
         occurrences all number
    12
    10
    11
    Blood creatinine increased
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 13 (23.08%)
    0 / 19 (0.00%)
         occurrences all number
    3
    4
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 12 (33.33%)
    3 / 13 (23.08%)
    1 / 19 (5.26%)
         occurrences all number
    6
    7
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    3
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    3
    4
    0
    Blood urea increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Eastern Cooperative Oncology Group performance status worsened
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Heart rate increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    8 / 19 (42.11%)
         occurrences all number
    1
    2
    11
    Radiation skin injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 13 (23.08%)
    1 / 19 (5.26%)
         occurrences all number
    1
    4
    1
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    1
    Dysaesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 12 (25.00%)
    2 / 13 (15.38%)
    4 / 19 (21.05%)
         occurrences all number
    3
    2
    7
    Leukopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Lymphocytosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    1
    Neutropenia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    3
    2
    0
    Eye disorders
    Eye Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    2
    Nausea
         subjects affected / exposed
    2 / 12 (16.67%)
    5 / 13 (38.46%)
    4 / 19 (21.05%)
         occurrences all number
    2
    13
    6
    Vomiting
         subjects affected / exposed
    4 / 12 (33.33%)
    6 / 13 (46.15%)
    1 / 19 (5.26%)
         occurrences all number
    4
    10
    1
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    3
    1
    Abdominal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Haematochezia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Oral pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 12 (25.00%)
    4 / 13 (30.77%)
    2 / 19 (10.53%)
         occurrences all number
    4
    5
    4
    Hepatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 13 (23.08%)
    4 / 19 (21.05%)
         occurrences all number
    1
    7
    4
    Rash
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    3 / 19 (15.79%)
         occurrences all number
    1
    3
    3
    Dry skin
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Uticaria
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Chronic kidney
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Glycosuria
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    3
    Back pain
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    1
    Groin pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    2
    Muscle spasms
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    2
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    2
    Hyperamylasaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2019
    The protocol title was amended to reflect study design. The protocol was amended to: - edit Inclusion Criterion #2, - add Exclusion Criteria of previous participation in another clinical trial of an investigational drug (or a medical device) within 30 days of study enrollment, - update and resolve inconsistencies in sample collection schedule for correlative studies described in Section 4.4.
    28 Dec 2020
    The protocol was amended to introduce Cohort 3 combining sotigalimab with SBRT in participants with unresectable or metastatic melanoma that failed available therapies and to adjust the sample size in Cohorts 1 and 2.

    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
    For support, Contact us.
    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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