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    Summary
    EudraCT Number:2018-002605-62
    Sponsor's Protocol Code Number:BCC1801
    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:2018-07-06
    Trial 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 number2018-002605-62
    A.3Full title of the trial
    Phase IIa trial with PD-L1 IO103 vaccination with montanide in patients with basal cell carcinoma.
    Vaccination mod PD-L1 IO103 til patienter med basal celle kræft
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination against PD-L1 in basal cell carcinoma - a phase IIa trial to assess immunologic effect.
    Vaccination mod PD-L1 ved basal celle kræft - et fase IIa studie til at belyse immunologisk effekt.
    A.4.1Sponsor's protocol code numberBCC1801
    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 SponsorHerlev and Gentofte 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 supportHerlev and Gentofte Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev and Gentofte Hospital
    B.5.2Functional name of contact pointDept of Dermatology and Allergy
    B.5.3 Address:
    B.5.3.1Street AddressKildegaardsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-maillone.skov02@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 No
    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 namePD-L1 (Long1)
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPD-L1 9-28
    D.3.9.1CAS number 190396-06-6
    D.3.9.2Current sponsor codePDL1 Long1
    D.3.9.3Other descriptive nameMONTANIDE ISA51
    D.3.9.4EV Substance CodeSUB33722
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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
    basal celle hudkræft
    E.1.1.1Medical condition in easily understood language
    skincancer
    hudkræft
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007286
    E.1.2Term Carcinoma basal cell
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial

    The aim of the phase 1 study is to investigate overall response rate and immunogenicity after vaccination with PD-L1 in patients with basal cell carcinoma

    I dette fase IIa studie behandles patienter med den hyppige form for hudkræft, basalcellekarcinombasal celle hudkræft, med cancervaccinen PD-L1 med navnet IO103. Vi vil undersøge, om vaccinen kan behandle basal celle hudkræftbasalcellekarcinom og undersøge vaccinens effekt på immunsystemet.
    E.2.2Secondary objectives of the trial
    Assess the immunologic response to vaccination with PD-L1 peptide i perifial blood and biopsies before, during and after vaccination
    Karakterisere immunresponser til vaccination med PD-L1 peptid i blod og biopsier før, under og efter vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 18
    At least 1 histological verified superficial or nodular basal cell carcinoma on the body or limbs of bigger than 14 mm in the longest diameter
    Willing to provide three 3 mm biopsies from the lesion/lesions
    Not previously treated with a hedgehog pathway inhibitor or retinoids
    ECOG performance score 0-1
    For women: Agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 26 weeks after the treatment.
    For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm
    Understand and be willing to sign written informed consent after oral and written information about the protocol.
    Sufficient bone marrow function, i.e.
    Leucocytes ≥ 1,5 x 109
    Granulocytes ≥ 1,0 x 109
    Thrombocytes ≥ 20 x 109
    Creatinine < 2.5 upper normal limit, i.e. < 300 µmol/l
    Sufficient liver function, i.e.
    ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/lBilirubin < 30 U/l
    Histologisk verificeret basalcellekarcinom basal celle hudkræft på krop, arm eller ben
    Alder ≥18 år
    Være villig til at få foretaget minimum 3 biopsier
    Adækvat knoglemarvsfunktion dvs.
    Leukocyttal > 1,5 x 109/l
    Granulocyttal > 1,0 x 109/l
    Trombocyttal > 20 x 109/l
    Kreatinin < 2,5 x øvre normal grænse dvs. kreatinin < 300 µmol/l
    Adækvat leverfunktion dvs.
    ALAT < 2,5 x øvre normal grænse, dvs. ALAT < 112 U/L
    Bilirubin < 30 U/L
    Kvinder i fertil alder skal have taget s-HCG forud for opstart af behandling og benytte sikker antikonception under behandlingen og indtil 26 uger efter sidste behandling. P-piller, spiral, depotinjektion med gestagen, subdermal implantation (f.eks. Implanon), hormonal vaginalring og hormonal transdermal depotplaster betragtes som sikre svangerskabsforebyggende metoder.
    Underskrevet informeret samtykke.
    E.4Principal exclusion criteria
    The patient has a history of life-threatening or severe immune related adverse events on treatment with another immunotherapy and is considered to be at risk of not recovering
    The patient has a history of severe clinical autoimmune disease
    The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C
    The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
    The patient is pregnant or breastfeeding
    The patient is unable to voluntarily agree to participate by signed informed consent or assent
    The patient has an active infection requiring systemic therapy
    The patient has received a live virus vaccine within 30 days of planned start of therapy
    Known side effects to Montanide ISA-51
    Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus
    Concurrent treatment with other experimental drugs
    Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
    Severe allergy or anaphylactic reactions earlier in life.
    Akut/kronisk infektion med f. eks. HIV, hepatitis, tuberkulose
    Alvorlig allergi eller tidligere anafylaktiske reaktioner
    Kendt overfølsomhed overfor Montanide ISA-51
    Gravide og ammende kvinder
    Fertile kvinder, som ikke anvender effektiv svangerskabsforebyggelse
    Tidligere behandling med Vismodegib
    Psykiatriske lidelser som ifølge investigators skøn kan indvirke på patientens compliance i forsøget
    Autoimmune sygdomme
    Samtidig behandling med andre eksperimentelle stoffer.
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate (DCR) defined as complete response (CR), partial response (PR), or stable disease (SD) of target lesion after 6 treatments with IO103. Rate of patients with CR, PR and SD.
    Objective and relative (%) reduction of the largest diameter of target lesion after 6 treatments with IO103.
    Undersøgelse af effekt af vaccination med PD-L1 defineret som a) fuld respons, delvist respons eller uændret sygdom efter 6 vaccinationer
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, then after second and sixth vaccination and during follow up
    Baseline, efter 2. og 6. vaccination og ved follow up
    E.5.2Secondary end point(s)
    Immune responses in biopsies from basal cell carcinomas (BCC) after treatment with IO103.
    Immune responses in skin delayed type hypersensitivity (DTH)
    Incidence of treatment emergent adverse events safety and tolerability)
    Udvikling af et målbart vaccineinduceret respons vurderet i perifert blod og ved biopsi. Undervejs kontrol af sikkerhed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples (around 110mL per sample) will be taken at baseline (immediately before the 1st vaccination) and immediately before the 6th vaccination for isolation of PBMC and serum.
    A tumor biopsy will be obtained at baseline (screening) and after 2 and 6 vaccinations.
    Blodprøver til immunmonitorering før behandlingsstart, samt ved follow up.
    Biopsi ved baseline, 2. og 6. vaccination. Delayed type hypersensitivity hudtest foretages efter 6. vaccination
    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 No
    E.6.4Safety Yes
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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
    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) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None, after the follow up visit, the patient is followed as a normal outpatient
    Ingen, efter opfølgende besøg følges patienten som normal ambulant patient
    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 Klinisk Forskningsenhed
    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 Decision2018-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-20
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