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    Summary
    EudraCT Number:2019-003310-14
    Sponsor's Protocol Code Number:SHO20190708
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-11-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2019-003310-14
    A.3Full title of the trial
    Laser immunotherapy with and without topical anti-PD1 in basal cell carcinomas
    Laser immunterapi med og uden topikal anti-PD1 til behandling af basal celle karcinomer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Laser-assisted immunotherapy in the treatment of basal cell skin cancer
    A.3.2Name or abbreviated title of the trial where available
    Laser immunotherapy and topical anti-PD1
    A.4.1Sponsor's protocol code numberSHO20190708
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Dermatology, Bispebjerg Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNone
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBispebjerg Hospital
    B.5.2Functional name of contact pointDepartment of Dermatology
    B.5.3 Address:
    B.5.3.1Street AddressNielsine Nielsens Vej 17, opg 9,2.sal
    B.5.3.2Town/ cityCopenhagne NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538635000
    B.5.6E-mailsilje.haukali.omland.01@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOpdivo
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Basal cell carcinoma in 24-30 patients
    E.1.1.1Medical condition in easily understood language
    Basal cell carcinoma in 24-30 patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • Tolerability of AFL+Nivolumab evaluated as local skin reactions
    • Detection of intra-tumoral Nivolumab evaluated by ELISA with anti-anti-PD1
    • Analysis and quantification of PD-L1 expression (tumor cells and TILs) evaluated by IHC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients 18 years or older
    • Histologically verified BCC, 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 prior to study treatment and must use a safe contraceptive method.
    E.4Principal exclusion criteria
    • Concomitant treatment with 5-FU or imiquimod
    • Concomitant chemotherapeutic treatment
    • Concomitant systemic immunotherapeutic treatment
    • Pregnant or lactating women
    • Allergies to anti-PD1
    • Patients with a tendency to form keloids
    • Other skin diseases or tattoos in the treatment area.
    E.5 End points
    E.5.1Primary end point(s)
    1. the immunological response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by IHC
    2. the clinical response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by tumor reduction measured in mm and documented by clinical photos
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. the immunological response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by IHC performed 1 week efter AFL+Nivolumab exposure
    2. the clinical response of AFL as monotherapy and AFL+Nivolumab in BCC evaluated by tumor reduction measured in mm and documented by clinical photos evaluated 12 weeks after AFL+Nivolumab exposure
    E.5.2Secondary end point(s)
    1. Tolerability of AFL+Nivolumab evaluated as local skin reactions
    2. Detection of intra-tumoral Nivolumab evaluated by ELISA with anti-anti-PD1
    3. Analysis and quantification of PD-L1 expression (tumor cells and TILs) evaluated by IHC
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Tolerability of AFL+Nivolumab evaluated as local skin reactions 1 week and 12 weeks after exposure
    2. Detection of intra-tumoral Nivolumab evaluated by ELISA with anti-anti-PD1 1 week after Nivolumab exposure
    3. Analysis and quantification of PD-L1 expression (tumor cells and TILs) evaluated by IHC performed at baseline visit prior to AFL+Nivolumab exposure
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunological response
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Herlev Hospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-11
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