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    Summary
    EudraCT Number:2018-001974-76
    Sponsor's Protocol Code Number:MK-3475-630
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001974-76
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
    Studio clinico di fase III, in doppio cieco, controllato con placebo per valutare Pembrolizumab versus Placebo nella terapia adiuvante a seguito di chirurgia e radioterapia in pazienti con alto rischio di Carcinoma cutaneo a cellule squamose localmente avanzato (LA cSCC) (Keynote 630)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC
    Pembrolizumab come terapia adiuvante per LA cSCC resecabile ad alto rischio
    A.3.2Name or abbreviated title of the trial where available
    Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC
    Pembrolizumab come terapia adiuvante per LA cSCC resecabile ad alto rischio
    A.4.1Sponsor's protocol code numberMK-3475-630
    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 SponsorMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00636191371
    B.5.5Fax number00636380371
    B.5.6E-mailgcto.italy@merck.com
    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 namePembrolizumab
    D.3.2Product code [MK-3475]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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.IMP: 2
    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 KEYTRUDA (pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name-
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Resectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)
    Carcinoma a cellule squamose cutanee localmente avanzato resecabile ad alto rischio (LA cSCC)
    E.1.1.1Medical condition in easily understood language
    High-risk Locally Advanced cutaneous squamous cell carcinoma (non-melanoma skin cancer)
    Carcinoma cutaneo a cellule squamose localmente avanzato ad alto rischio (carcinoma cutaneo non melanoma)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10041823
    E.1.2Term Squamous cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the recurrence-free survival (RFS), as assessed by the investigator and confirmed by biopsy, in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy
    confrontare la sopravvivenza libera da recidiva (Recurrence-Free Survival, RFS), valutata dallo sperimentatore e confermata da biopsia, nei soggetti che ricevono pembrolizumab rispetto ai soggetti che ricevono il placebo come terapia adiuvante.
    E.2.2Secondary objectives of the trial
    1. To compare overall survival (OS) in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy
    2. To compare mean change from baseline in health-related quality of life (HRQoL) scores from the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ)-C30, in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy
    3. To determine the safety and tolerability of pembrolizumab as adjuvant therapy
    1. Confrontare la sopravvivenza complessiva (Overall Survival, OS) nei soggetti che ricevono pembrolizumab rispetto ai soggetti che ricevono il placebo come terapia adiuvante.
    2. Confrontare la variazione media dal basale nei punteggi relativi alla qualità della vita correlata alla salute (Health-Related Quality of Life, HRQoL) del questionario QoL (QLQ)-C30 dell’Organizzazione Europea per la ricerca e cura del cancro (European Organisation for Research and Treatment of Cancer, EORTC) tra i soggetti che ricevono pembrolizumab e i soggetti che ricevono placebo come terapia adiuvante.
    3. Per determinare la sicurezza e la tollerabilità di pembrolizumab come terapia adiuvante
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Merck will conduct Future Biomedical Research on DNA (Blood and tissue) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Merck condurrà la Ricerca Futura Biomedica sul DNA (sangue e campioni di tessuto) raccolti durante questo studio clinico. Tale ricerca è per test sui biomarcatori per affrontare domande emergenti non descritte altrove nel protocollo (come parte della prova principale) e sarà solo condotto su campioni provenienti da soggetti appropriatamente autorizzati. L'obiettivo di raccogliere campioni per la Ricerca Futura Biomedica è quello di esplorare e identificare i biomarcatori che informano la comprensione scientifica di malattie e/o dei loro trattamenti terapeutici.
    L'obiettivo generale è utilizzare tali informazioni per sviluppare farmaci più sicuri e più efficaci e/o per assicurarsi che i soggetti ricevano la dose corretta del farmaco corretto presso il ora corretta.
    E.3Principal inclusion criteria
    1Particip must have histologically conf cSCC as primary site of malignancy (metastatic skin involv from another primary cancer or unknown primary cancer isnt permitted)
    2Particip must have undergone complete macrosc resection of all known cSCC disease with/without microsc pos margins
    For particip with residual microsc posit margin involv, confirmation additional re-excision isnt possible must be provided. Surgery consist of 1or combina of:
    a)Resection of primary lesion
    b)Any type neck dissec
    c)Any type of parotidectomy(sup tot part)
    3Particip must have hist conf LA cSCC with highrisk feature(s) as primary site of malign (metastatic skin involvem from another primary cancer or unknown primary cancer isnt permit)
    Highrisk features include at least 1 of:
    a)Hist involved nodal disease with:
    •Extracaps exten with at least 1 lymphnode>2cm in greatest diam or>=2 lymph involved
    b)Index tumor with>=2 of:
    •Tum>=4cm with depth>6mm or invasion beyond subcut fat
    •Multif perineural invas for nerves of<0.1mm diam(3 or more foci)or any inv nerve>=0.1mm diam
    •Poor differentiation and/or sarcomatoid and/or spindle cell histology
    •Recur disease(cSCC that recurs 3 y in prev surgically/topically treat area)
    •Satellite lesions and/or in transit metast
    c)Gross cortical bone or skull base and/or skull base foramen invasion
    4Particip must have completed adjuvant RT for LA cSCC with last dose of RT>=4 weeks and <=16 w from randomiz
    5Particip must have compl at least45Gy of adjuv RT for LA cSCC prior study entry
    6Particip disease-free as assessed by investig with compl radiogr staging assessment<=28 days from random
    7Particip is male or fem at least18years at time signing inf consent
    8Contraceptive use by wom be consistent with local regulat regarding methods of contrac for particip in clinic studies
    •Fem particip is eligible if she isnt pregnant or breastfeeding, and at least 1 of foll cond applies:
    -Isnt wom of childbearing potential(WOCBP)
    OR
    -IsWOCBP using contracept meth highly effective(failure rate<1%per year),or abstinent from heterosex intercourse and usual lifestyle(abstinent long term and persistent basis),during intervention period and for at least120days after last dose of study interv. Investig should eval potential for contrac meth failure(ie,noncompliance,rec initiated)in rel to first dose of stud interv
    -WOCBP must have neg highly sensitive pregn test within72h before first dose of st interv
    -If urine test cannot be conf neg,serum pregn test is requir. Particip must be excluded if serum pregn result is pos
    9Particip(or legal representative, if appl)provides written inf consent for study. Particip may prov consent for fut biomed research, may particip in main st without particip in fut biom res
    10Particip prov a tum tissue sample adeq forPD-L1 testing determ by centr lab testing. This may be obt from surgical resect or prior archiv tissue specimen not prev irrad.FFPE tissue blocks are pref to slides
    11Particip has life expectancy>3 months
    12Particip has EasternCoopOncologyGroup(ECOG)perform status of 0or1perf within10days prior treatm initiat
    13Particip has adeq organ funct.Specimens must be collected within10days prior start of st treat
    1Partecip devono presentre cSCC confermato istologic come sito primario di tum maligno(nn consentito coinvolg cutaneo metastatico altro tum primario o tum primario nn noto)
    2Partecip deve essere sottoposto a resez macrosc compl tutta malatt cSCC nota con o snz margini positivi microscopici. Per part con coinv del marg pos microsc res, occorre conf della imposs di esciss addiz. Intervento chirurgico può consistere seguenti procedure o combinaz delle stesse:
    aResez lesione primaria
    bQuals tipo dissez collo
    cQuals tipo parotidectomia(superf,tot,parz)
    3Partecip deve presentre LA cSCC con caratteristica/e alto rischio confermato istologic come sito primario di tum maligno(nn consentito coinvolg cutaneo metastatico altro tum primario o tum primario nn noto).
    Le caratt alto rischio includ almeno seguenti fatt:
    a)Malatt linfonodale istologic coinvolta con seguenti caratt:
    -
    -estensione extracaps con alm 1 linf>2cm diam mag o >=2 linf coinv
    b)Quals indice tumor con=2seguenti caratt alto rischio:
    -Tum>=4cm con profondità>6mm o invas oltre gras sottocut
    -Invas perineurale multifocale per nervi di diametro<0,1mm(3 o più foci)o quals nervo coinvolto diametro=0,1mm
    -Scarsa differenz e/o istologia sarcomatoide e/o cell fusate -Malatt ricorrente (quals cSCC che si ripresenti entro 3 anni nell’area precedent trattata chirurgicam o per via topica)
    -les satel(satell) e/o in metast trans
    cQuals invas macrosc osso corticale o invas base cranio e/o invas forame base cranio.
    4Partecip deve aver compl terap adiuvante conRTperLAcSCC ultima doseRT
    -=4sett=16 sett randomizz.
    5partecip deve aver complto almeno45frazioni Gy di RTadiuvante perLAcSCC prima ingresso nstu.
    6partecip è libero da malatt,cm valutato sperim con valutaz stadiaz radiografica compl=28ggrandomizz.
    7partecip è maschio o femmina almeno18 anni età momento firma consenso inf
    8L’uso di contraccettivi parte donne deve essere linea normative locali riguardanti metodi contracc per coloro partecipano agli studi clinici.
    •Partecip di sesso femminile è idonea alla partecipaz qualora nn sia stato gravidanza,nn stia allattando al seno e soddisfi almeno una delle condiz che seguono:
    -Nn è donna in età fertile
    OPP -Donna età fertile e utilizza met contraccettivo altamente efficace (con un tasso di fallimento<1% all’anno)o pratica astinenza dai rapp eterosessuali come stile vita preferito e abituale(astinenza lungo termine e continuativa),dur il period di interv e almeno120gg dp ultima dose di intervento stu.Sperim deve valutare il potenz di fallimento metodo contraccettivo(vale a dire,nn aderenza,inizio recente) in relaz alla prima dose intervento stu.
    -Donna età fertile deve presentre risultato negativo a test gravidanza altamen sensibile(come richiesto normative locali)entro72ore preced prima dose intervento stu.
    -In caso nn sia poss conf negatività test urine(in caso risultato ambiguo),è richiesto test gravidanza sul siero.Tali casi,partecip deve essere esclusa ìpartecipaz se risultato test gravidanza siero è positivo.
    9Partecip(o rapp legalm accett,se applic)fornisce consenso infor scritto stu.Partecip può inoltre decidere di fornire consenso ricerca biomedica futura.Partecip ha comun possib partecip stu princip senza partecip ricer biomedica futura.
    10Partecip fornisce camp tess tumor adeguato testPDL1determ mediante analisi lab centrale.Qst campione tissutale può essere ottenuto dp resez chirurgica o da un preced campione tessuto archivio nn precedent irradiato.Blocchetti tessuto FFPE sono preferibili rispetto ai vetrini.
    11Partecip ha aspettativa vita sup ai3mesi.
    12Partecip ha statovalidità 0o1base Scala validitàGruppo orientale oncologia cooperativa (EasternCooperativeOncology Group,ECOG)valutato entro10gginizio tratt
    E.4Principal exclusion criteria
    1. Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
    2. Has any other histologic type of skin cancer other than invasive cSCC, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen’s disease, MCC, melanoma
    3. A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another costimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
    5. Has received prior systemic anticancer therapy including investigational agents for cSCC within 4 weeks prior to randomization
    6. Participant must have recovered from all radiation-related toxicities, not have required corticosteroids, and not have had radiation pneumonitis
    7. Has received a live vaccine within 30 days prior to the first dose of study treatment.Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
    are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
    8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
    9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
    10. Has a diagnosed and/or treated additional malignancy within the past 5 years prior to randomization
    11. Has known active central nervous system metastases and/or carcinomatous meningitis
    12. Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients
    13. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive
    drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of
    systemic treatment and is allowed
    14. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
    15. Has an active infection requiring systemic therapy
    16. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
    17. Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
    reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection
    18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
    19. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
    20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days
    after the last dose of study treatment
    21. Has had an allogeneic tissue/solid organ transplant
    1Pres cSCC residuo macroscopico dp intervento chirurgico e/o recidiva con mal cSCC attiva prima randomiz.
    2Pres qualsiasi altro tipo istologico di tum della pelle diverso da cSCC invasivo carc a cellbasali che non è stato definitiv trattato con intervento chirurgico o radioterap, mal Bowen, MCC,melanoma.
    3Donna età fertile con test di gravidanza sulle urine positivo nelle72ore preced prima dose del tratt studio.In caso test sulle urine positivo o cui negatività non possa essere confermata, è richiesto test di gravidanza sul siero.Tal casi,partecip deve essere esclusa dalla partecipazione se risultato test gravidanza siero è positivo.
    4Preced terap con un agente antiPD1,antiPDL1 o antiPDL2 o con un agente diret contro un altro recettore co-stimolatorio o co-inibitorio dei linfT(CTLA4,OX40,CD137).
    5Preced terap antitumorale sist,inclusi agenti sperim per cSCC nelle 4 sett preced larandomiz.
    6Partecip deve essersi ristabilito tutte tossicità correlate alla radioterap e non presre polmonite da radiaz
    7Ha ricevuto vaccino vivo nei 30 gg preced la prima dose del tratt dello studio.Es vaccini vivi comprendono, tit esemplificativo ma non esaustivo, i seguenti:morbillo, orecchioni, rosolia, varicella/zoster, febbre gialla,rabbia,bacillo di CalmetteGuérin(BCG)e vaccino tifoideo.Vaccini per influenza stagionale somministrati iniez genere sono vaccini con virus inattivati e sono ammessi;tuttavia vaccini antinfluenzali intranasali(adFlu-Mist®)sn vaccini vivi attenuati e non sono consentiti.
    8Attuale o pregressa partecip e stu agente sperim o uso dispositivo sperim entro 4 sett prima della prima dose di tratt dello studio.
    9Diagnosi di immunodef o tratt in corso con terap steroidea sist cronica (a dosi superiori 10mg giorno un equivalente del prednisone) o qualsiasi altra forma terap immunosoppressiva entro 7 gg prima della prima dose di farmaco dello studio.
    10Pres ulteriori malignità diagnosticate e/o trattate entro gli ultimi5annipreced alla randomizzazione.
    11Pres metastasi attive note al sistema nervoso centrale e/o meningite carcinomatosa.
    12Pres ipersens grave (grado =3) a pembrolizumab e/o a uno qualunque dei suoi eccipientim (per un elenco degli eccipienti, consultare il dossier dello
    sperimentatore).
    13Pres una mal autoimmune fase attiva che ha rich un tratt sistemico ultimi2anni (ossia con impiego di agenti modificanti decorso mal,corticosteroidi o farmaci immunosopp)Terap
    sostitutiva(tiroxina,insulina o terap sostitutiva con dosi fisiologiche di corticosteroidi per insuff surrenalica o pituitaria)non è considerata una forma di tratt
    sistemico ed è consentita.
    14Ha anamnesi polmonite (non infettiva) che ha richiesto uso steroidi o pres una polmonite atto.
    15Pres un’infez attiva con necessità di terap sist.
    16Pres anamnesi nota di infez da virus immunodef umana(HIV).Non è richiesto alcun test per HIV salvo se prescritto dall’autorità sanitaria locale.
    17Pres nota anamnesi di infez da virus dell’epatite B (definita come reattiva all’antigene di superficie dell’epatite B [Hepatitis B Surface Antigen, HBsAg]) o nota infez attiva da virus dell’epatite C (HVC; definita come rilevamento dell’HCV nell’RNA [qualitativo]).
    18Pres un’anamnesi o attuale evidenza di qualsiasi condizione, terap o valore di lab non normale che potrebbe confondere i risultati dello studio, interferire con la partecip
    della partecip per tutta la durata dello studio o non è nel miglior interesse della partecip parteciparvi, secondo opinione dello sperimeresponsabile del tratt.
    19Disturbo noto natura psichiatrica o da abuso sostanze potrebbe interferire con capacità del partecip di osservare requisiti dello studio.
    20. Partecip in stato di gravidanza o allattamento o che prevede di concepire o generare figli entro la durata prevista dello studio, a partire dalla visita di screening fino a 120 gg dp l’ultima dose di tratt dello studio.
    21. Ha subito un trapianto di organo solido/tessuto allogenico
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence-free survival (RFS) as assessed by the investigator and confirmed by biopsy
    Sopravvivenza libera da recidiva (RFS) valutata dallo sperimentatore e confermata mediante biopsia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 60 months
    Fino a circa 60 mesi per la valutazione della sopravvivenza libera da recidiva
    E.5.2Secondary end point(s)
    1. Overall Survival (OS)
    2. Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORT QLQ-C30) Score
    3. Change From Baseline in Phisical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORT QLQ-C30) Items 1-5 Score
    4. Percentage of participants who experience an adverse event (AE)
    5. Percentage of participants who discontinue study treatment due to an adverse event (AE)
    1. Sopravvivenza Complessiva (OS)
    2. Cambiamento rispetto al basale nel punteggio del Questionario Qualità della vita (EORTC QLQ-C30) dell'Organizzazione Europea per la ricerca e il trattamento del cancro (EORTC)
    3. Cambiamento rispetto al basale della funzionalità fisica usando il punteggio del Questionario Qualità della vita (EORTC QLQ-C30) dell'Organizzazione Europea per la ricerca e il trattamento del cancro
    4. Percentuale di partecipanti che manifestano un evento avverso (AE)
    5. Percentuale di partecipanti che interrompono il trattamento di studio a causa di un evento avverso (AE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 60 months
    2. Baseline and up to approximately 60 months
    3. Baseline and up to approximately 60 months
    4. Up to approximately 63 months
    5. Up to approximately 38 months
    1. Fino a circa 60 mesi
    2. Baseline e fino a circa 60 mesi
    3. Baseline e fino a circa 60 mesi
    4. Fino a circa 63 mesi
    5. Fino a circa 38 mesi
    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 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 Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Ritrattamento in aperto
    open-label retreatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    Israel
    Mexico
    Russian Federation
    United States
    France
    Germany
    Greece
    Hungary
    Italy
    Portugal
    Romania
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 285
    F.4.2.2In the whole clinical trial 570
    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
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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