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    Clinical Trial Results:
    Laser immunotherapy with and without topical anti-PD1 in basal cell carcinomas

    Summary
    EudraCT number
    		 2019-003310-14
    Trial protocol
    		 DK  
    Global end of trial date
    11 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2023
    First version publication date
    16 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHO20190708
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Dermatology
    Sponsor organisation address
    Bispebjerg bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Department of Dermatology, Bispebjerg Hospital, 0045 38635000, silje.haukali.omland.01@regionh.dk
    Scientific contact
    Department of Dermatology, Bispebjerg Hospital, 0045 38635000, silje.haukali.omland.01@regionh.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
    01 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aim is to assess the immunological and clinical response in BCC treated with AFL or intratumoral nivolumab as monotherapy and compare with BCC treated with combination-therapy of AFL and the anti-PD1-drug Nivolumab (intratumoral). Primary objectives 1. To investigate the immunological response of AFL or intratumoral nivolumab as monotherapy and AFL+Nivolumab (intratumoral) in BCC 2. To investigate the clinical response of AFL or nivolumab (intratumoral) as monotherapy and AFL+Nivolumab in BCC
    Protection of trial subjects
    In case of Suspected Unexpected Serious Adverse Reactions (SUSARs), the study sponsor will immediately inform The Danish Medicines Agency and the Regional Committee on Health Research Ethics according to detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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
    20
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 In an undisturbed setting, the participant will be made aware of their right to have an assessor present, that participation is voluntary, and that withdrawal is possible at any time during the study. Participants will be given adequate consideration time (min 24 h). Participants will be asked to sign a consent form

    Pre-assignment
    Screening details
    		 • Patients 18 years or older • Clinical suspicion of BCC or histologically verified BCC at baseline and histologically verified BCC at visit 2, irrespective of histologic subtype with diameter ≥7 mm at baseline. • Signed informed consent. • Female subjects of childbearing potential must be confirmed not pregnant by a negative pregnancy test

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anti-PD1+AFL
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Opdivo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Injection
    Dosage and administration details
    0.10 ml Nivolumab solution/cm2, intratumoral injection

    Arm title
    		 Arm_AFL
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    opdivo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 ml per cm^2

    Arm title
    		 Anti-PD1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Opdivo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Injection
    Dosage and administration details
    0.10 ml Nivolumab solution/cm2, intratumoral injection

    Number of subjects in period 1
    		Anti-PD1+AFL Arm_AFL Anti-PD1
    Started
    10
    9
    9
    Completed
    10
    9
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All patients included in the three groups

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 28 28
    Age categorical
    18-100 years
    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
    		 20 20
        85 years and over
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    Anti-PD1+AFL
    Reporting group description
    		 -

    Reporting group title
    Arm_AFL
    Reporting group description
    		 -

    Reporting group title
    Anti-PD1
    Reporting group description
    		 -

    Primary: Change in CD3+ T-cells

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    End point title
    		 Change in CD3+ T-cells
    End point description
    Primary objectives 1. To investigate the immunological response of AFL as monotherapy and AFL+Nivolumab in BCC 2. To investigate the clinical response of AFL as monotherapy and AFL+Nivolumab in BCC
    End point type
    Primary
    End point timeframe
    End of trial
    End point values
    		 Anti-PD1+AFL Arm_AFL Anti-PD1
    Number of subjects analysed
    10
    9
    9
    Units: CD3+ cells
        arithmetic mean (standard deviation)
    10 ( 2 )
    9 ( 2 )
    9 ( 2 )
    Statistical analysis title
    		 Comparison of CD3 positive cells
    Comparison groups
    Anti-PD1+AFL v Anti-PD1 v Arm_AFL
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Primary: Tumor reduction

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    End point title
    		 Tumor reduction
    End point description
    Primary objectives To investigate the clinical response of AFL as monotherapy and AFL+Nivolumab in BCC
    End point type
    Primary
    End point timeframe
    End of trial
    End point values
    		 Anti-PD1+AFL Arm_AFL Anti-PD1
    Number of subjects analysed
    10
    9
    9
    Units: Tumor reduction
        number (not applicable)
    10
    9
    9
    Statistical analysis title
    		 Comparison of CD3+ cells before/after intervention
    Statistical analysis description
    The CD3+ cells were analyzed before and after intervention for all three intervention groups
    Comparison groups
    Anti-PD1+AFL v Arm_AFL v Anti-PD1
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From intervention to end-of trial
    Adverse event reporting additional description
    Local skin reaction
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Local skin reactions
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Anti-PD1+AFL
    Reporting group description
    		 Local skin reactions: all patients experienced local skin reactions consisting of either eythema, crusting og scaling one-week post-intervention. The skin reactions were reduced at month three, however some experienced hyperpigmentation to a mild degree

    Reporting group title
    Arm_AFL
    Reporting group description
    		 Local skin reactions: all patients experienced mild local skin reactions consisting of either erythema, edema ,crusting og scaling one-week post-intervention. One patient had an infection at the intervention side that required oral anitbiotics. The skin reactions were reduced at month three. At month three one patient experienced hyperpigmentation to a mild degree.

    Reporting group title
    Anti-PD1
    Reporting group description
    		 Local skin reactions: all patients experienced local skin reactions consisting of either erythema, crusting og scaling one-week post-intervention. The skin reactions were reduced or totally resolved at month three, however some experienced hyperpigmentation to a mild degree

    Serious adverse events
    		 Anti-PD1+AFL Arm_AFL Anti-PD1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Anti-PD1+AFL Arm_AFL Anti-PD1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    Infections and infestations
    Local skin infection
    Additional description: One week after AFL treatment one patient developed a local skin oínfection at the intervention site that was treated with oral antibiotics.
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (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? 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
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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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