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    Summary
    EudraCT Number:2017-001774-41
    Sponsor's Protocol Code Number:MM04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2017-001774-41
    A.3Full title of the trial
    A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy.
    Studio randomizzato, in aperto, di fase 2/3 con cellule dendritiche caricate con lisato di cellule tumorali allogeniche (PheraLys) in soggetti con mesotelioma come terapia di mantenimento (MesoPher) dopo chemioterapia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on dendritic cell therapy as maintenance therapy for patients that have been treated for Mesothelioma.
    Studio sulla terapia cellulare dendritica come terapia di mantenimento per i pazienti che sono stati trattati per il mesotelioma.
    A.3.2Name or abbreviated title of the trial where available
    DENIM (DENdritic Cell Immunotherapy for Mesothelioma)
    DENIM
    A.4.1Sponsor's protocol code numberMM04
    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 SponsorAMPHERA BV
    B.1.3.4CountryNetherlands
    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 supportUnione Europea
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmphera BV
    B.5.2Functional name of contact pointIlona Enninga
    B.5.3 Address:
    B.5.3.1Street AddressOnderwijs boulevard 225
    B.5.3.2Town/ city's Hertogenbosch
    B.5.3.3Post code5223 DE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031736274520
    B.5.5Fax number0031736274520
    B.5.6E-mailIlona.Enninga@amphera.nl
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1229
    D.3 Description of the IMP
    D.3.1Product nameMesoPher
    D.3.2Product code [MesoPher]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMESOPHER
    D.3.9.4EV Substance CodeSUB188358
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Pleural malignant mesothelioma.
    Mesotelioma maligno pleurico.
    E.1.1.1Medical condition in easily understood language
    Malignant mesothelioma, cancer of the lung pleura.
    Mesotelioma maligno, cancro della pleura polmonare.
    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 10027407
    E.1.2Term Mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the overall survival rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.
    Obiettivo primario dello studio è valutare il tasso di sopravvivenza complessivo (SC) (determinato dal tempo di randomizzazione dello studio) dei pazienti che ricevono immunoterapia a cellule dendritiche con MesoPher oltre alla migliore terapia di supporto (MTS) a fronte della sola MTS.
    E.2.2Secondary objectives of the trial
    • to evaluate the overall survival rate at 12 and 18 months after
    randomization, in subjects who receive dendritic cell immunotherapy
    with MesoPher plus BSC compared to BSC alone.
    • to evaluate progression free survival in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone.
    • to evaluate the overall response rate and duration of response in subjects who receive dendritic cell immunotherapy with MesoPher plus
    BSC compared to BSC alone.
    • to evaluate quality of life in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone.
    • to evaluate the safety and tolerability of dendritic cell immunotherapy with MesoPher.
    • valutare il tasso di sopravvivenza complessivo a 12 e 18 mesi dopo randomizzazione nei soggetti che ricevono immunoterapia a cellule dendritiche con MesoPher oltre alla MTS a fronte della sola MTS;
    • valutare la sopravvivenza senza progressione nei soggetti che ricevono immunoterapia a cellule dendritiche con MesoPher oltre alla MTS a fronte della sola MTS;
    • valutare il tasso di risposta complessivo e la durata della risposta nei soggetti che ricevono immunoterapia a cellule dendritiche con MesoPher oltre alla MTS a fronte della sola MTS;
    • valutare la qualità della vita nei soggetti che ricevono immunoterapia a cellule dendritiche con MesoPher oltre alla MTS a fronte della sola MTS;
    • valutare la sicurezza e la tollerabilità dell’immunoterapia a cellule dendritiche con MesosPher.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study.
    2. Subjects with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive (so CR, PR or SD) after 4 to 6 cycles with first line chemotherapy with antifolate/platinum (as determined by CT scanning). Subjects retreated with antifolate/platinum after a disease-free interval of 12 months after the first
    chemotherapeutic treatment are eligible. Concurrent bevacizumab during chemotherapy is allowed but patients who receive bevacizumab will only be eligible if they stop bevacizumab due to non-tolerance before or by the end of the chemotherapy period. Patients who benefit from bevacizumab use may continue treatment with bevacizumab and will consequently not be eligible for the study .
    3. Subject must have signed informed consent within 8 weeks of their last chemo and the date of their informed consent must be such that all per protocol required procedures can be done in such a timeframe that the first treatment can be given within 9 and 13 weeks after their last chemotherapy.
    4. Measurable disease has to be assessed by modified RECIST criteria on CT scanning by radiologic imaging. Even in the absence of measurable disease patients can be included in the study. In such case CT scanning will also be done to evaluate the disease.
    5. Subjects must be at least 18 years old.
    6. Subjects must have WHO-ECOG performance status of 0 or 1.
    7. Subjects must have adequate organ function and adequate bone marrow reserve at screening:
    - creatinine <= 1.5 × upper limit of normal [ULN] or glomerular filtration
    rate> = 50mL/min
    - ALT, AST, bilirubin< = 1.5 × ULN
    - Absolute neutrophil count >=1.5 x 1000000000/L, platelet coun>t =100 x
    1000000000/L, and Hb =9.0g/dL.
    8. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test just prior to the first study drug administration on Day 1, and must be willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) or true abstinence (when this is in line with the preferred and usual lifestyle)*
    during the study and for at least 12 months after the last study drug administration.
    9. Men must be willing to use an effective contraceptive method (e.g. condom, vasectomy) during the study and for at least 12 months after the last study drug administration.
    10. Subjects must be willing and able to follow the protocol requirements and must be willing and able to return to the study center for adequate follow-up visits.
    1. Modulo di consenso informato firmato (ICF) che indica una comprensione degli scopi, i rischi e le procedure richiesti per lo studio e disponibilità e capacità di partecipare allo studio.
    2. Soggetti con diagnosi istologicamente confermata di mesotelioma pleurico maligno, che non sono in progressione (quindi CR, PR o SD) dopo 4 a 6 cicli con chemioterapia di prima linea con antifolato / platino (determinata mediante scansione TC). Soggetti ritrattati con antifolato / platino dopo un intervallo libero da malattia di 12 mesi dopo il primo trattamento chemioterapico sono ammissibili. Il Bevacizumab come trattamento concomitante durante la chemioterapia è permesso ma i pazienti che ricevono bevacizumab saranno eleggibili solo se interrompono Bevacizumab a causa della non tolleranza prima o entro la fine del periodo di chemioterapia. I pazienti che traggono beneficio dal l'uso di bevacizumab possono continuare il trattamento con bevacizumab e di conseguenza non sono ammissibile per lo studio.
    3. Il soggetto deve avere firmato il consenso informato entro 8 settimane dalla sua ultima chemio e la data del consenso informato deve essere tale che tutte
    le procedure richieste dal protocollo possono essere eseguite in tale lasso di tempo e che il primo trattamento può essere somministrato entro 9 e 13 settimane dopo l'ultimo chemioterapia.
    4. La malattia misurabile deve essere valutata con i criteri RECIST modificati su Scansione TC mediante imaging radiologico. Anche in assenza di malattia misurabile
    i pazienti possono essere inclusi nello studio. In tal caso la scansione CT sarà anche fatta per valutare la malattia.
    5. I soggetti devono avere almeno 18 anni.
    6. I soggetti devono avere una performance status WHO-ECOG pari a 0 o 1.
    7. I soggetti devono avere una funzione organica adeguata e una riserva di midollo osseo adeguata allo screening:
    - creatinina< = 1,5 × limite superiore del normale [ULN] o filtrazione glomerulare
    tasso >= 50mL / min
    - ALT, AST, bilirubina <= 1,5 × ULN
    - Conteggio assoluto dei neutrofili >= 1,5 x 1000000000 / L, conta piastrinica> =100 x 1000000000 / L e Hb =9,0 g / dL.
    8. Le donne in età fertile devono avere un test di gravidanza negativo ottenuto su sangue allo screening e un test di gravidanza delle urine negativo prima della prima somministrazione di farmaco il primo giorno, e devono essere d’accordo di utilizzare un metodo contraccettivo efficace (dispositivi intrauterini, ormonali
    contraccettivi, pillola anticoncezionale, protesi, cerotti transdermici, dispositivi vaginali ormonali, infusioni a rilascio prolungato) ovvero astinenza (quando è in linea con lo stile di vita preferito e abituale) * durante lo studio e per almeno 12 mesi dopo l'ultimo farmaco in studio amministrazione.
    9. Gli uomini devono essere disposti a utilizzare un metodo contraccettivo efficace (ad es. preservativo, vasectomia) durante lo studio e per almeno 12 mesi dopo
    l'ultima somministrazione del farmaco in studio.
    10. I soggetti devono essere disposti e in grado di seguire il protocollo requisiti e devono essere disposti a tornare al centro per le visite di follow-up
    E.4Principal exclusion criteria
    1. Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
    2. Subject with any serious intercurrent chronic or acute illness such as cardiac (New York Heart Association [NYHA] Class III or IV) or hepatic disease or other serious concomitant disease considered by the investigator to constitute an unwarranted high risk for investigational dendritic cell treatment.
    3. Subject with any known active serious infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus or syphilis infection.
    4. Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor.
    5. Subject who has received an organ allograft.
    6. Subject with any previous malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the subject has been disease-free for at least 3 years.
    7. Subject with a known allergy to shell fish (may contain KLH).
    8. Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraceptive methods (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 12 months after the last study drug administration.
    9. Subject with inadequate peripheral vein access to perform leukapheresis.
    10. Use of >10 mg of steroids (or other immunosuppressive agents) during the past 6 weeks before the first study drug administration and throughout the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid </=10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
    11. Treatment with any investigational product within 4 weeks or 5 halflives (whichever is longer) before the first study drug administration or concomitant participation in another clinical study.
    12. Subject who is unwilling or unable to follow the protocol requirements, including availability for follow-up assessment.
    1. Soggetti con patologie o patologie mediche, psicologiche o psichiatriche che possano interferire con le procedure oi risultati dello studio o che secondo il parere dello sperimentatore costituirebbero un rischio per la partecipazione a questo studio.
    2. Soggetti con malattie croniche o acute gravi intercorrenti come il cuore (New York Heart Association [NYHA] Classe III o IV) o malattia epatica o altre gravi patologie concomitanti considerate dallo sperimentatore come un elevato rischio ingiustificato per il trattamento sperimentale delle cellule dendritiche .
    3. Soggetto con qualsiasi infezione grave attiva nota, tra cui virus dell'immunodeficienza umana (HIV) e virus dell'epatite B o C o infezione da sifilide.
    4. Soggetto con anamnesi di malattia autoimmune, ad eccezione del diabete mellito di tipo I o di altre condizioni, in cui il paziente può essere idoneo dopo una discussione con un monitor medico.
    5. Soggetto che ha ricevuto un allotrapianto di organo.
    6. Soggetto con qualsiasi precedente neoplasia, ad eccezione del carcinoma cutaneo a cellule basocellulari o cellule squamose adeguatamente trattato, tumore superficiale o in situ della vescica o di altro tumore per il quale il soggetto è stato libero da malattia per almeno 3 anni.
    7. Soggetto con una nota allergia ai molluschi (può contenere KLH).
    8. Donne incinte, madri che allattano, donne che allattano e donne in età fertile che non sono disposte a utilizzare metodi contraccettivi efficaci (dispositivi intrauterini, contraccettivi ormonali, pillola anticoncezionale, impianti, cerotti transdermici, dispositivi vaginali ormonali, infusioni a rilascio prolungato) durante lo studio e per almeno 12 mesi dopo l'ultima somministrazione del farmaco in studio.
    9. Soggetto con insufficiente accesso alla vena periferica per eseguire la leucaferesi.
    10. Uso di> 10 mg di steroidi (o altri agenti immunosoppressivi) nelle ultime 6 settimane prima della somministrazione del primo farmaco in studio e durante lo studio. L'uso profilattico di desametasone durante la chemioterapia è escluso da questo intervallo di 6 settimane. Gli steroidi per via inalatoria o topica e gli steroidi sostitutivi surrenalici </ = 10 mg al giorno di prednisone equivalenti sono consentiti in assenza di malattia autoimmune attiva.
    11. Trattamento con qualsiasi prodotto sperimentale entro 4 settimane o 5 mesi di riposo (a seconda del periodo più lungo) prima della somministrazione del primo farmaco in studio o della concomitante partecipazione a un altro studio clinico.
    12. Soggetti che non vogliono o non sono in grado di seguire i requisiti del protocollo, inclusa la disponibilità per la valutazione di follow-up.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be overall survival (OS). Overall survival will be determined as the time from randomization (about 3 to 4 months after diagnosis) until death. For subjects who are alive at the end of the study or lost to follow-up, OS will be censored on the last date when subjects are known to be alive.
    L’endpoint primario dello studio è la sopravvivenza complessiva (SC). La sopravvivenza complessiva è definita come il tempo trascorso dalla randomizzazione (all’incirca da 3 a 4 mesi dopo la diagnosi) al decesso. Per i soggetti in vita alla fine dello studio o irreperibili al follow-up, la SC sarà valutata in base all’ultima data conosciuta relativa alla sopravvivenza dei pazienti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study.
    Death.
    Fine dello studio
    Morte
    E.5.2Secondary end point(s)
    • Survival status at 12, and 18 months after randomization.
    • Progression-free survival (PFS), including symptomatic (clear evident signs of disease progression) progression-free survival. Progression free survival (PFS) will be determined by the local investigators from CT scans, using the modified RECIST criteria. The time of the first CT scan showing progression (i.e., time to progression) will define the end of the PFS.
    • Overall response rate and duration of response. Overall response rate
    is defined as the proportion of subjects with confirmed CR or PR according to the modified RECIST criteria (i.e. CR or PR that persist on repeat imaging performed >4 weeks after the initial documentation of response). Response to treatment will be determined at every CT scan.
    • The change in Quality of Life from baseline.
    seguenti endpoint di efficacia sono considerati secondari:
    • Stato di sopravvivenza al 12° e al 18° mese dopo la randomizzazione
    • Sopravvivenza senza progressione (SSP), inclusa la sopravvivenza senza progressione sintomatica (chiari segni evidenti di progressione della malattia)
    La sopravvivenza senza progressione (SSP) sarà stabilita dai ricercatori responsabili a livello locale dalle scansioni di TC, secondo i criteri RECIST modificati. La scadenza temporale relativa alla prima scansione di TC che evidenza segni di progressione (ossia il tempo alla progressione) definisce il termine della SSP.
    • Tasso di risposta complessivo e durata della risposta
    Il tasso di risposta complessivo è definito come la proporzione di soggetti con risposta completa (RC) o risposta parziale (RP) confermate secondo i criteri RECIST modificati, ossia la persistenza della RC o della RP su più immagini eseguite >4 settimane dopo la documentazione iniziale di risposta. La risposta al trattamento sarà determinata a ogni scansione di TC.
    • Variazione della qualità della vita rispetto al baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 18 months after randomisation
    12 e 18 mesi dopo la randomizzazione
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Migliore cura di supporto
    Best Supportive Care
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Migliore cura di supporto
    Best Supportive Care
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Information not present in EudraCT
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 230
    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)
    Best supportive care.
    Migliore cura di supporto
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
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