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    Summary
    EudraCT Number:2017-000589-31
    Sponsor's Protocol Code Number:NEMESIS
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2017-000589-31
    A.3Full title of the trial
    multi stage phase II trial of Nivolumab (an anti –PD-1) in patients with platinum resistant Mismatch Repair deficient germinal cells tumours
    Studio di fase II multi step sul Nivolumab (un anti-PD-1) in pazienti con tumore a cellule germinali, resistenti al platino e deficitari del sistema di riparazione del Mismatch
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nivolumab in pre-treated advanced germ cells tumours patients with Mismatch repair deficiency
    Nivolumab in pazienti con deficit del sistema di riparo del Mismatch in tumori a cellule germinali resistenti al platino
    A.3.2Name or abbreviated title of the trial where available
    NEMESIS- Nivolumab in pre-treated advanced germ cells tumours patients with Mismatch repair deficien
    NEMESIS - Nivolumab in pazienti con deficit del sistema di riparo del Mismatch in tumori a cellule g
    A.4.1Sponsor's protocol code numberNEMESIS
    A.5.4Other Identifiers
    Name:NEMESISNumber:NEMESIS
    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 SponsorSOCIETà CAMPANA DI IMMUNOTERAPIA ONCOLOGICA
    B.1.3.4CountryItaly
    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 supportBRISTOL-MYERS SQUIBB
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology Srl
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street Addressvia San Leonardo trav. Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailnemesis@cr-technology.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 Yes
    D.2.1.1.1Trade name OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namenivolumab
    D.3.2Product code [BMS-936558]
    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 INNNivolumab
    D.3.9.2Current sponsor codeNivolumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    patients with platinum resistant Mismatch Repair deficient germinal cells tumours
    pazienti con tumore a cellule germinali, resistenti al platino e deficitari del sistema di riparazione del Mismatch
    E.1.1.1Medical condition in easily understood language
    patients with platinum resistant Mismatch Repair deficient germinal cells tumours
    pazienti con tumore a cellule germinali, resistenti al platino e deficitari del sistema di riparazione del Mismatch
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061184
    E.1.2Term Germ cell cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061184
    E.1.2Term Germ cell cancer
    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 evaluate the anti-tumour activity of nivolumab in Germ Cells Tumours microsatellite instability (MSI) and/or DNA repair defects including mismatch-repair gene deficiency (MMR).
    Valutare l’attività anti tumorale del Nivolumab nei pazienti con Tumore a Cellule Germinali con instabilità dei microsatelliti (MSI) e/o difetti nella riparazione del DNA incluso il deficit dei geni coinvolti nella riparazione del mismatch (MMR).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the effects associated with nivolumab in terms of:
    • Progression free survival per RECIST 1.1;
    • Overall survival;
    • Proportion of patients with conversion of CTC count from =5/7.5ml blood at baseline to <5/7.5 ml blood nadir;
    • Safety and tolerability of nivolumab.
    • Sopravvivenza libera da progressione (PFS);
    • Sopravvivenza globale (OS);
    • Proporzione di pazienti con conversione della conta di CTC nel sangue da = 5/7.5 ml al baseline a <5/7.5 ml durante il nadir;
    • Sicurezza e tollerabilità del Nivolumab.
    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: V.1.0 del 21 July,2017
    Microsatellite instability using Promega
    Immunohistochemistry for MMR proteins
    Evaluation of CD8+ T-lymphocyte count
    Evaluation of mutational load and identification of MMR difective genes on NGS using targeted panel
    Evaluation of MDSCs (CD14+ HLA-DR low CD33+) infiltration and of CD4+ CD25+ FoxP3+ Tregs
    Evaluation of PDL-1 expression in tumour and stromal cells

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: v.1.0 del 21 luglio 2017
    Instabilità dei microsatelliti utilizzando Promega
    Immunoistochimica per proteine MMR
    Valutazione della conta dei linfociti T CD8+
    Valutazione della carica mutazione e identificazione dei geni deficitari di MMR utilizzando NGS targeted panel
    Valutazione dell'infiltrato MDSCs (CD14+ HLA-DR low CD33+)and di CD4+ CD25+ FoxP3+
    Valutazione dell'espressione di PDL-1 nel tumore e nelle cellule stromali
    E.3Principal inclusion criteria
    1) Signed and dated IRB/IEC-approved Informed Consent;
    2) Male patients> 18 years;
    3) Life expectancy > 3 months;
    4) Performance status (ECOG) = 2;
    5) Histological or clinical diagnosis of GCTs;
    6) Availability of archival tissue (paraffine block or at least 10 unstained slides) to evaluate the PD-L1 status, which is positive (expression = 1 percent of tumour cells) or negative;
    7) Microsatellite instability (MSI) and/or DNA repair defects including mismatch-repair gene deficiency (MMR-).
    8) Either gonadal or extragonadal tumour primary;
    9) Failure of = 2 prior chemotherapy regimens for metastatic GCT disease (1-2 cycles PEB or 1 cycle carboplatinum AUC7 given in the adjuvant setting for clinical stage I disease will not be counted as prior lines);¿
    10) Brain metastases: patients who present with brain metastases as the sole site of disease relapse/progression are not allowed to enter the study. Otherwise, patients with massive systemic spread with brain metastases will be allowed to enrol into the study, provided that they will not undergo concomitant brain radiation, brain surgery or they are judged to be at high-risk of bleeding (high-volume metastases with haemorrhagic spots resulting at either CT or ¿MRI scan of the brain);
    11) Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by v.CTCAE 4.0);
    12) Patients must not have had major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 3 weeks prior to entering the study;
    13) Patients must have adequate organ and marrow function (as defined below). Patients must have returned to baseline or grade 1 from any acute toxicity related to prior therapy. Laboratory test must be performed within 3 days before date of treatment
    1. Absolute neutrophil count = 1,500/mm;
    2. Hemoglobin = 9 g/dL;
    3. Platelets = 100,000/mm;
    4. Total bilirubin = 1.5 x institutional upper limit of normal (ULN), except for patients affected by Gilbert’s syndrome;
    5. AST(SGOT)/ALT(SGPT) = 3 x institutional ULN (5x if LFT elevations due to liver metastases);
    14) Male who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
    1) Consenso Informato approvato da comitato Etico firmato e datato;
    2) Pazienti maschi > 18 anni;
    3) Aspettativa di vita > 3 mesi;
    4) Performance status (ECOG) = 2;
    5) Diagnosi istologica o clinica di GCT;
    6) Disponibilità di tessuto d’archivio (blocco in paraffina o almeno 10 vetrini non colorati) per valutare lo stato di PD-L1, che può essere positivo (espressione = 1% di cellule tumorali) o negativo;
    7) Instabilità dei microsatelliti (MSI) e/o difetti nella riparazione del DNA incluso il deficit dei geni coinvolti nella riparazione del mismatch (MMR-);
    8) Tumore primario gonadico o extragonadico;
    9) Fallimento di 2 o più precedenti regimi di chemioterapia per la malattia metastatica (1-2 cicli di PEB o 1 ciclo di carboplatino AUC7 somministrati in un setting adiuvante per lo stadio I di malattia non saranno considerati come linee precedenti);
    10) Metastasi al cervello: i pazienti che presentano metastasi al cervello come unico sito di recidiva/progressione di malattia non sono autorizzati ad entrare nello studio. In caso contrario, i pazienti con diffusione sistemica massiva e con metastasi al cervello saranno autorizzati ad entrare nello studio, a condizione che non si sottopongano a radioterapia cerebrale concomitante, a chirurgia cerebrale o che non siano ad alto rischio di sanguinamento (metastasi di elevato volume con macchie emorragiche che risultano alla scansione CT o alla MRI al cervello);
    11) Pazienti che hanno recuperato al grado G1 da tossicità legate alla terapia precedente (definito da v. CTCAE 4.0);
    12) Assenza di interventi chirurgici maggiori, radioterapia, chemioterapia, terapia biologica (che include qualsiasi agente sperimentale) o terapia ormonale (tranne quella sostitutiva), nelle 3 settimane precedenti l’ingresso nello studio;
    13) adeguata funzionalità d'organo e del midollo (come definito di seguito). I pazienti devono tornare al baseline o al grado 1 da qualsiasi tossicità acuta legata alla terapia precedente. I test di laboratorio devono essere eseguiti entro 3 giorni dalla data del trattamento
    1. Conta assoluta dei neutrofili = 1,500/mm;
    2. Emoglobina = 9 g/dL;
    3. Piastrine = 100.000/mm;
    4. Bilirubina totale = 1,5 volte il limite superiore di normalità (ULN), ad eccezione dei pazienti affetti da sindrome di Gilbert;
    5. AST (SGOT)/ALT (SGPT) = 3 ULN (5 volte se gli incrementi di LFT sono dovuti a metastasi epatiche);
    14) Maschi che sono sessualmente attivi con WOCBP devono accettare di seguire le istruzioni fornite per i metodi di contraccezione a partire dalla prima dose di terapia e per i 7 mesi successivi all'ultima dose di terapia dello studio.
    E.4Principal exclusion criteria
    1) Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because of the steroids administration. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator;
    2) Patients with a diagnosis of immunodeficiency or is receiving steroid therapy and/or immunosuppressive therapy within 7 days before the treatment starting;
    3) Patients with a diagnosis of active autoimmune disease requiring systemic treatment within the past 90 days, or a documented history of clinically severe autoimmune disease, that requires systemic steroids and/or immunosuppressive agents. Patients with vitiligo or resolved asthma/atopy or stable hypothyroidism, will not be excluded from the trial;
    4) Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment;
    5) Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy;
    6) Previous (within the last 5 years) or current malignancies at other sites, except for basal cell or squamous cell skin cancer that have undergone potentially curative treatment;
    7) Current enrolment in or participation in another therapeutic clinical trial within 4 weeks before the first dose of treatment;
    8) Patients with uncontrolled or significant cardiovascular disease within 12 months, unstable angina within 6 months, NYHA Class III, poorly controlled hypertension, ongoing symptomatic cardiac dysrhythmias and uncontrolled atrial fibrillation;
    9) Known HIV infection;
    10) Patients with a diagnosis of interstitial lung disease or non-infectious pneumonitis;
    11) Patient with a diagnosis of active hepatitis B (HBsAg reactive) or C (HCV-RNA qualitative is detected);
    12) Patients who received a live vaccine one month before the treatment starting;
    13) Patients who received treatment with mAb within one month before the first dose of trial treatment;
    14) Patients who have had radiotherapy or chemotherapy within 14 days of the first dose of trial treatment.
    1) Pazienti con metastasi cerebrali sintomatiche dovrebbero essere esclusi da questa sperimentazione clinica a causa della loro scarsa prognosi e della somministrazione di steroidi. Tuttavia, i pazienti che hanno ricevuto un trattamento per le loro metastasi cerebrali e il cui stato di malattia metastatica cerebrale è rimasta stabile per almeno 3 mesi senza somministrazione di steroidi possono essere arruolati a discrezione dello sperimentatore;
    2) Pazienti con una diagnosi di immunodeficienza o sottoposti a terapia con steroidi e/o terapia immunosoppressiva nei precedenti 7 giorni dall'inizio del trattamento;
    3) Pazienti con una diagnosi di malattia autoimmune attiva che hanno richiesto un trattamento sistemico negli ultimi 90 giorni o che hanno una storia documentata di malattia autoimmune clinicamente grave, che richiede il trattamento con steroidi sistemici e/o agenti immunosoppressivi. Pazienti con vitiligine o con una condizione di asma/atopia risolta o con ipotiroidismo stabile, non saranno esclusi dallo studio;
    4) Chirurgia maggiore, ad eccezione della chirurgia diagnostica, nelle 4 settimane precedenti al trattamento;
    5) Infezioni batteriche, virali o fungine attive, non controllate, che richiedono una terapia sistemica;
    6) Tumori precedenti in altri siti (negli ultimi 5 anni) o correnti, ad eccezione dei tumori basocellulari o squamocellulari della cute che sono stati sottoposti a un trattamento potenzialmente curativo;
    7) Arruolamento in atto o partecipazione ad altro studio clinico terapeutico nelle 4 settimane precedenti alla prima dose di trattamento;
    8) Pazienti con malattia cardiovascolare incontrollata o significativa (SCA nei precedenti 12 mesi, angina instabile nei precedenti 6 mesi, NYHA di Classe III, ipertensione mal controllata, disritmia cardiaca sintomatica in atto e fibrillazione atriale incontrollata;
    9) Infezione da HIV nota;
    10) Pazienti con diagnosi di malattia polmonare interstiziale o polmonite non infettiva;
    11) Paziente con diagnosi di epatite B (HBsAg reattivo) o di epatite C (rilevazione di HCV-RNA qualitativo) attive;
    12) Pazienti che hanno ricevuto un vaccino vivo un mese prima dell’inizio del trattamento;
    13) Pazienti che hanno ricevuto un trattamento con mAb entro un mese dalla prima dose di trattamento;
    14) Pazienti sottoposti a radioterapia o chemioterapia entro 14 giorni dalla prima dose di trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Disease Control Rate (DCR) by - RECIST v1.1
    Endpoint Primario Tasso di controllo della malattia (DCR) attraverso i criteri RECIST v 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    18/20 months for the first stage( 18 patients) and 36/40 months for stage 2 (17 patients )
    18/20 mesi per i primi 18 pazienti (step 1) e 36/40 mesi per i successivi 17 pazienti (step 2)
    E.5.2Secondary end point(s)
    • Progression free survival (PFS);
    • Overall survival (OS);
    • Proportion of patients with conversion of CTC count from = 5/7.5ml blood at baseline to <5/7.5 ml blood nadir;; Safety and tolerability of nivolumab.; Tertiary Endpoints
    • Evaluation of CD8+ T-lymphocyte count in blood and tumour biopsies.
    • Evaluation mutational load and identification of MMR difective genes on NGS using targeted panel
    • Evaluation of MDSCs (CD14+ HLA-DR low CD33+) infiltration in resistant testicular germinal tumours biopsies and of CD4+ CD25+ FoxP3+ Tregs in blood and tissue
    • Evaluation of of PD-1 and PDL-1 expression in tumour and stromal cells in tumour biopsies.
    • Sopravvivenza libera da progressione (PFS);
    • Sopravvivenza globale (OS);
    • Proporzione di pazienti con conversione della conta di CTC nel sangue da = 5/7.5 ml al baseline a <5/7.5 ml durante il nadir;
    ; Sicurezza e tollerabilità del Nivolumab.; Endpoints terziari:
    • Valutazione della conta dei linfociti T CD8 + nel sangue e nelle biopsie tumorali;
    • Valutazione del carico mutazionale e identificazione dei geni difettivi MMR con NGS mediante pannello mirato;
    • Valutazione dell'infiltrazione di MDSCs (CD14 + HLA-DR low CD33 +) nelle biopsie di tumori germinali testicolari resistenti e di CD4 CD25 + FoxP3 + Tregs nel sangue e nei tessuti;
    • Valutazione dell'espressione di PD-1 e PDL-1 nei tumori e delle cellule stromali nelle biopsie tumorali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36/40 Months; 3 months after patient 18th enroll; 36/40 months
    36/40 mesi; 3 mesi dal diciottesimo paziente arruolato; 36/40 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 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 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 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 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 concerned10
    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 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 years0
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    F.2 Gender
    F.2.1Female No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects incapable of giving consent for physical or physiological reasons, or reasons linked to their medical condition (e.g. mental disability)
    Soggetti incapaci di dare il consenso per motivi fisici o fisiologici, o per ragioni legate alla condizione clinica (ad esempio disabilita' mentale).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 38
    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)
    As clinical practice
    terapie previste da pratica clinica
    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 Decision2018-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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