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    Summary
    EudraCT Number:2018-002941-12
    Sponsor's Protocol Code Number:INCMGA0012-203
    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:2021-01-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002941-12
    A.3Full title of the trial
    A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
    Studio di fase II su INCMGA00012 (inibitore di PD-1) in partecipanti affetti da tumori solidi selezionati (POD1UM-203)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With
    Selected Solid Tumors (POD1UM-203)
    Studio di fase II su INCMGA00012 (inibitore di PD-1) in partecipanti affetti da tumori solidi selezionati (POD1UM-203)
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-2
    Studio di fase II su INCMGA00012 (inibitore di PD-1) in partecipanti affetti da tumori solidi selezi
    A.4.1Sponsor's protocol code numberINCMGA0012-203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03679767
    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 SponsorINCYTE CORPORATION
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000000
    B.5.5Fax number13024252734
    B.5.6E-mailRA@incyte.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 nameretifanlimab
    D.3.2Product code [INCMGA00012]
    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.3.9.1CAS number 2079108-44-2
    D.3.9.2Current sponsor codeINCMGA00012
    D.3.9.3Other descriptive nameMGA012
    D.3.9.4EV Substance CodeSUB191459
    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) No
    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 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 nameretifanlimab
    D.3.2Product code [INCMGA00012]
    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.3.9.1CAS number 2079108-44-2
    D.3.9.2Current sponsor codeINCMGA00012
    D.3.9.4EV Substance CodeSUB191459
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male or female, 18 years or older with histologically or cytologically
    confirmed diagnosis of :
    a. NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.
    b. advanced or metastatic UC in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a CPS = 10.
    c. unresectable or metastatic melanoma.
    d. advanced or metastatic RCC with clear cell component and having received no prior systemic therapy
    Partecipanti di sesso maschile e femminile di età pari ad almeno 18 anni, con diagnosi confermata istologicamente o citologicamente di:
    a. NSCLC con elevata espressione di PD-L1 (TPS=50%) e nessuna aberrazione tumorale genomica attivante di EGFR, ALK o ROS.
    b. UC metastatico o avanzato in pazienti non idonei a ricevere cisplatino il cui tumore esprime PD-L1
    c. Melanoma metastatico o non resecabile.
    d. RCC metastatico o localmente avanzato non trattato con una precedente terapia sistemica
    E.1.1.1Medical condition in easily understood language
    Adults with advanced NSCLC, UC, melanoma, or RCC
    Adulti con NSCLC, UC, melanoma, o RCC in stato avanzato
    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 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10038395
    E.1.2Term Renal carcinoma
    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
    To assess the efficacy of INCMGA00012 in terms of the ORR in tumor types of interest.
    Valutare l’efficacia di INCMGA00012 in termini di tasso di risposta globale (Overall Response Rate, ORR)
    E.2.2Secondary objectives of the trial
    To determine the DOR , DCR, PFS, OS, safety, and PK of INCMGA00012
    Determinare DOR , DCR, PFS, OS, Sicurezza e PK di INCMGA00012
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Following criteria apply:
    1. Ability to comprehend and willingness to sign a written ICF for the study.
    2. Men and women 18 years of age or older (or as applicable per local country requirements).
    3. Confirmed diagnosis of one of the following:
    a. Treatment-naïve metastatic NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.
    b. Locally-advanced or metastatic UC in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a CPS = 10.
    c. Unresectable or metastatic melanoma.
    d. Locally advanced or metastatic RCC with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy
    4. Measurable disease per RECIST v1.1.
    5. ECOG performance status 0 to 1.
    6. Willingness to avoid pregnancy or fathering children as described in the protocol.
    1. Capacità di comprendere e volontà di firmare un modulo di consenso informato scritto per lo studio.
    2. Pazienti di sesso maschile e femminile di età pari o superiore a 18 anni (o secondo quanto applicabile ai sensi dei requisiti nazionali locali).
    3. Diagnosi confermata di una delle seguenti condizioni:
    a. Carcinoma polmonare non a piccole cellule (Non-Small Cell Lung Cancer, NSCLC) metastatico naïve al trattamento con elevata espressione di PD-L1 (TPS =50%) e nessuna aberrazione tumorale genomica attivante di EGFR, ALK o ROS.
    b. UC metastatico o localmente avanzato in partecipanti non idonei a ricevere la terapia a base di cisplatino e il cui tumore esprime PD-L1 con CPS =10.
    c. Melanoma metastatico o non resecabile.
    d. RCC metastatico o localmente avanzato con componente a cellule chiare (con o senza caratteristiche sarcomatoidi) non trattato in precedenza con una terapia sistemica
    4. Malattia misurabile in base ai criteri RECIST v. 1.1.
    5. Stato prestazionale ECOG pari a 0-1.
    6. Disponibilità ad evitare di concepire un figlio in base ai criteri di cui sotto.
    E.4Principal exclusion criteria
    1. Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
    2. Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
    a. Adjuvant therapy that was completed = 12 months before study entry may be acceptable but should be discussed with the medical monitor before enrolling the participant on study.
    3. Radiotherapy within 14 days of first dose of study treatment with the following caveats:
    a. 28 days for pelvic radiotherapy.
    b. 6 months for thoracic region radiotherapy that is > 30 Gy.
    c. 14 days for palliative radiation therapy
    Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.
    4. Toxicity of prior therapy that has not recovered to = Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
    5. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
    6. Participants with laboratory values at screening defined in Table 7 of the Protocol.
    7. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.8. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
    a. Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
    b. Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.
    c. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
    d. Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment–related standard premedication are permitted.
    9. Evidence of interstitial lung disease or active noninfectious pneumonitis.
    10. Known active CNS metastases and/or carcinomatous meningitis.
    Note: Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases or CNS edema, and have not required steroids for at least 14 days before the first dose of study drug.
    [........]
    1. Trattamento oncologico o partecipazione a un altro studio clinico interventistico nei 21 giorni precedenti alla prima somministrazione del farmaco in studio.
    2. Precedente trattamento con terapia mirata al PD-1 o PD-L1 (altre immunoterapie potrebbero essere ammesse previa approvazione del monitor medico).
    a) Un’eventuale terapia adiuvante completata =12 mesi prima dell’ingresso nello studio potrebbe essere accettabile ma deve essere discussa con il monitor medico prima di arruolare il partecipante nello studio.
    3. Radioterapia nei 14 giorni precedenti alla somministrazione della prima dose del trattamento in studio, con le seguenti precisazioni:
    a. 28 giorni per la radioterapia pelvica.
    b. 6 mesi per la radioterapia alla regione toracica a dose >30 Gy.
    c. 14 giorni per la radioterapia palliativa.
    Nota: i partecipanti devono essersi ristabiliti da tutte le eventuali tossicità correlate alle radiazioni, non aver bisogno di corticosteroidi per tale scopo e non presentare polmonite da radiazioni.
    4. Tossicità associata alla terapia precedente non risolta a un grado =1 o al valore basale (fatta eccezione per l’anemia che non richiede trasfusioni e l’alopecia di qualsiasi grado).
    L’endocrinopatia, se ben gestita, non costituisce un criterio di esclusione e deve essere discussa con il monitor medico dello sponsor.
    5. Tossicità e/o complicazioni associate a un intervento chirurgico non risoltesi adeguatamente prima dell’inizio del trattamento con il farmaco in studio.
    6. Valori di laboratorio allo screening definiti nella tabella 7 del Protocollo.
    7. Neoplasia maligna aggiuntiva nota in progressione o che rende necessario un trattamento attivo, oppure anamnesi di altra neoplasia maligna nei 3 anni precedenti all’ingresso nello studio, fatta eccezione per il carcinoma cutaneo basocellulare o a cellule squamoso trattato, il carcinoma superficiale della vescica, il tumore prostatico intraepiteliale, il carcinoma in situ della cervice o altra neoplasia maligna non invasiva o indolente o tumori dai quali il partecipante è libero da oltre
    1 anno dopo il trattamento con intento curativo.
    8. Malattia autoimmune attiva che rende necessaria l’immunosoppressione sistemica superiore alle dosi di mantenimento fisiologico di corticosteroidi (>10 mg di prednisone o equivalente).
    a. È ammessa la terapia sostitutiva fisiologica a base di corticosteroidi a dosi >10 mg/die di prednisone o equivalente per l’insufficienza surrenale o ipofisaria e in assenza di malattia autoimmune attiva.
    b. I soggetti affetti da asma per i quali è necessario l’uso intermittente di broncodilatatori, steroidi per via inalatoria o iniezioni steroidee locali possono partecipare allo studio.
    c. I soggetti che fanno uso di steroidi topici, oculari, intrarticolari o intranasali (con assorbimento sistemico minimo) possono partecipare allo studio.
    d. Sono ammessi brevi cicli di corticosteroidi a fini profilattici (ad es. per l’allergia al mezzo di contrasto) o la premedicazione standard correlata al trattamento in studio.
    9. Evidenza di malattia polmonare interstiziale o polmonite attiva non infettiva.
    10. Metastasi a carico del SNC e/o meningite carcinomatosa attive note.
    Nota: i partecipanti con metastasi cerebrali precedentemente trattate possono partecipare purché siano stabili (senza evidenza di progressione agli esami di diagnostica per immagini da almeno 28 giorni prima della prima dose di farmaco in studio ed eventuali sintomi neurologici ristabilitisi al livello basale), non presentino evidenza di metastasi cerebrali o edema al SNC di nuova insorgenza o in ingrandimento, e che non abbiano avuto bisogno di steroidi da almeno 14 giorni prima della prima dose del farmaco in studio.
    [.....]
    E.5 End points
    E.5.1Primary end point(s)
    ORR, defined as the percentage of participants having a CR or PR, according to RECIST v1.1 as determined by the investigator.
    L’endpoint primario dello studio è l’ORR, definito come la proporzione di partecipanti che ottengono una risposta obiettiva (CR o PR) secondo i criteri RECIST v 1.1 in base a quanto determinato dallo sperimentatore
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Per la durata dello studio
    E.5.2Secondary end point(s)
    DOR, defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until first observation of documented disease progression as determined by investigator or death due to any cause.
    DCR, defined as the proportion of participants with either an objective response PFS, defined as the time from the start of therapy until disease progression, as determined by investigator or death due to any cause.
    OS, defined as the time from the start of therapy until death due to any cause.
    Safety, determined by the number of participants, frequency, duration, and severity of AEs, laboratory tests, vital signs, and ECGs.
    The PK of INCMAG00012 including Cmax, tmax, Cmin, and AUCt, will be summarized.
    La DOR è definita come il tempo che intercorre tra una risposta obiettiva (CR o PR) iniziale secondo i criteri RECIST v. 1.1 e la prima osservazione di progressione della malattia documentata in base a quanto determinato dallo sperimentatore o il decesso per qualsiasi causa.
    Il DCR è definito come la proporzione di partecipanti che presentano una risposta obiettiva (CR e PR) o malattia stabile (Stable Disease, SD) secondo i criteri RECIST v. 1.1.
    L’OS è definita come il tempo che intercorre tra l’inizio della terapia e il decesso per qualsiasi causa.
    La sicurezza è determinata in base al numero di partecipanti, la frequenza, la durata e la gravità degli eventi avversi (Adverse Event, AE), i test di laboratorio, i parametri vitali e gli ECG.
    Verrà riepilogata la PK di INCMGA00012, comprendendo Cmax, tmax, Cmin e AUCt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Per la durata dello studio
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity
    Immunogenicità
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    open
    open
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    United States
    Austria
    France
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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 years3
    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 years3
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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)
    nessuno
    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 Decision2019-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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