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    Clinical Trial Results:
    PHASE II INVESTIGATION OF THE HISTOPATHOLOGIC EFFECT OF CALCIUM ELECTROPORATION ON CANCER IN THE SKIN

    Summary
    EudraCT number
    		 2019-004315-31
    Trial protocol
    		 DK  
    Global end of trial date
    27 Jul 2023

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CaEP-B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04259658
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Ringstedgade 61, Næstved, Denmark, 4700
    Public contact
    Lars Munch Larsen, Zealand University Hospital, laml@regionsjaelland.dk
    Scientific contact
    Julie Gehl, Zealand University Hospital, kgeh@regionsjaelland.dk
    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 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Oct 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment (biopsy taken on the day of treatment before the calcium electroporation procedure). TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.
    Protection of trial subjects
    Patients included had consented in writing and fulfilled all eligibility criteria. Standard safety monitoring was performed during treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2020
    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
    Denmark: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    6
    From 65 to 84 years
    10
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from Dept. of Oncology, Zealand University Hospital.

    Pre-assignment
    Screening details
    		 Patients with any solid cancer and cutaneous metastases could be screened for inclusion. Patients could recieve other treatment.

    Period 1
    Period 1 title
    Inclusion, treatment and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Patients treated with calcium electroporation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcium chloride
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    Tumors were measured (a longest diameter, b diameter perpendicular to a). A 3 mm margin was added. Calcium chloride was mixed to 220 mM (mixed with sodium chloride). a. Tumour with a diameter <0.5 cm: 1 ml of calcium chloride solution pr cm3 tumour tissue was injected. b. Tumour with a diameter from 0.5 cm to 3 cm: 0.5 ml of calcium chloride solution pr cm3 tumour tissue was injected. (Maximum volume is 20 ml 220 mmol/l calcium chloride.)

    Number of subjects in period 1
    		Experimental
    Started
    17
    Completed
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inclusion, treatment and follow-up
    Reporting group description
    		 -

    Reporting group values
    		 Inclusion, treatment and follow-up Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 10 10
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 2 2
    Subject analysis sets

    Subject analysis set title
    TIL infiltration in biopsies
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Infiltration of TILs in biopsies on day 2 relative to pre-treatment was analysed

    Subject analysis sets values
    		 TIL infiltration in biopsies
    Number of subjects
    17
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    6
        From 65-84 years
    10
        85 years and over
    1
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    2

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Patients treated with calcium electroporation

    Subject analysis set title
    TIL infiltration in biopsies
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Infiltration of TILs in biopsies on day 2 relative to pre-treatment was analysed

    Primary: Difference in TIL population from before to two days after treatment in tumor biopsy

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    End point title
    		 Difference in TIL population from before to two days after treatment in tumor biopsy [1]
    End point description
    TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.
    End point type
    Primary
    End point timeframe
    The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were performed only within biopsies in the same patient. Results reported in paper as listed.
    End point values
    		 Experimental
    Number of subjects analysed
    17
    Units: percent
        number (not applicable)
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE's was evaluated systematically until 2 months post calcium electroporation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Bleeding
    Additional description: The patient was hospitalized due to bleeing from the biopsy locations. It was deemed not to be related to the study treatment but related to a chemotherapy related thrombocythopenia.
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 17 (35.29%)
    Skin and subcutaneous tissue disorders
    Suppuration
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Ulceration
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Skin
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38804839
    http://www.ncbi.nlm.nih.gov/pubmed/37436059
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