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    Clinical Trial Results:
    Traitement des carcinomes à cellules de Merkel inopérables et/ou métastatiques par analogue de la somatostatine – Etude nationale multicentrique mono-bras de phase II.

    Summary
    EudraCT number
    		 2014-001273-13
    Trial protocol
    		 FR  
    Global end of trial date
    15 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2022
    First version publication date
    17 Jul 2022
    Other versions
    Summary report(s)
    		 document justifying the missing/partial results _ PHRC MERKEL

    Trial information

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    Trial identification
    Sponsor protocol code
    38RC14.040
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02351128
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grenoble Alpes University Hospital
    Sponsor organisation address
    CS 10217, Grenoble , France, 38043
    Public contact
    CIC Cancérologie, University Hospital of Grenoble , 33 476769481, ChMendoza@chu-chu-grenoble.fr
    Scientific contact
    Cancérologie, University Hospital of Grenoble , 33 4 76 76 70 81, SMouret@chu-chu-grenoble.fr
    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
    29 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of lanreotide at 3 months in patients with inoperable and/or metastatic Merkel cell carcinoma (MCC).
    Protection of trial subjects
    Treatment of localized forms of MCC is currently based on surgery and radiotherapy, but when patients are in the metastatic stage no survival benefit has been demonstrated using chemotherapy, unlike other neuroendocrine tumors. The prognosis for patients with stage IV disease is severe with a 1-year survival of about 44%. Chemotherapy is therefore currently considered a palliative treatment in case of disseminated disease. In this context we can offer this treatment to these patients. The clinical benefits of this treatment have been observed in some patients without side effects. This treatment already has MA in other indications and is well tolerated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    2
    From 65 to 84 years
    23
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inoperable or histologically confirmed merkel cell carcinoma stage III B or IV (according to AJCC 2010 classification) First line of treatment or more At least one measurable target of more than 20 mm with a conventional scanner or more than 10 mm with a spiral scanner or evaluable clinical targets

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

    Arms
    Arm title
    		 intervention
    Arm description
    		 lanretoride
    Arm type
    		 Experimental

    Investigational medicinal product name
    lanréotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    120 mg each 28 days

    Number of subjects in period 1
    		intervention
    Started
    35
    Completed
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    lanreotide
    Reporting group description
    		 -

    Reporting group values
    		 lanreotide Total
    Number of subjects
    		 35 35
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 23 23
        85 years and over
    		 10 10
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 lanretoride

    Subject analysis set title
    One Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    One Arm analysis

    Primary: efficacy of lanreotide

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    End point title
    		 efficacy of lanreotide
    End point description
    Treatment will be considered effective if 40% of patients have a positive response. The positive response is defined by all patients with either a complete response, a partial response, or a stable response according to RECIST 1.1 criteria.
    End point type
    Primary
    End point timeframe
    evaluation at 3 months of treatment
    End point values
    		 intervention One Arm
    Number of subjects analysed
    35
    35
    Units: RECIST 1.1 criteria.
        number (not applicable)
    35
    35
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    intervention v One Arm
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Shapiro-Wilks
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During all the study periods
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 lanretoride

    Serious adverse events
    		 intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Metabolism and nutrition disorders
    Hyponatraemia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 35 (11.43%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2015
    Updating of the centres and associated investigators. The investigators' table is removed from the protocol and appended separately. Somatuline SPC update, minor version update.

    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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