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    Summary
    EudraCT Number:2015-001995-23
    Sponsor's Protocol Code Number:NIBIT-MESO-1
    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:2021-09-30
    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 number2015-001995-23
    A.3Full title of the trial
    A SINGLE ARM, PHASE II CLINICAL STUDY OF TREMELIMUMAB COMBINED WITH THE ANTI-PD-L1 MEDI4736 MONOCLONAL ANTIBODY IN UNRESECTABLE MALIGNANT MESOTHELIOMA SUBJECTS: NIBIT-MESO-1 STUDY
    STUDIO CLINICO DI FASE II, A SINGOLO BRACCIO DI TRATTAMENTO CON LA COMBINAZIONE TREMELIMUMAB E L’ANTICORPO MONOCLONALE ANTI-PD-L1 MEDI4736 A IN SOGGETTII CON MESOTELIOMA MALIGNO NON RESECABILE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A SINGLE ARM, PHASE II CLINICAL STUDY OF TREMELIMUMAB COMBINED WITH THE ANTI-PD-L1 MEDI4736 MONOCLONAL ANTIBODY IN UNRESECTABLE MALIGNANT MESOTHELIOMA SUBJECTS: NIBIT-MESO-1 STUDY
    STUDIO CLINICO DI FASE II, A SINGOLO BRACCIO DI TRATTAMENTO CON LA COMBINAZIONE TREMELIMUMAB E L’ANTICORPO MONOCLONALE ANTI-PD-L1 MEDI4736 A IN SOGGETTII CON MESOTELIOMA MALIGNO NON RESECABILE
    A.3.2Name or abbreviated title of the trial where available
    NIBIT-MESO-1
    NIBIT-MESO-1
    A.4.1Sponsor's protocol code numberNIBIT-MESO-1
    A.5.4Other Identifiers
    Name:NIBIT-MESO-1Number:NIBIT-MESO-1
    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 SponsorFONDAZIONE NIBIT NETWORK ITALIANO PER LA BIOTERAPIA DEI TUMORI
    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 supportAstra Zeneca
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione NIBIT
    B.5.2Functional name of contact pointStudy Coordinator Studio NIBIT-MESO
    B.5.3 Address:
    B.5.3.1Street AddressAzienda Ospedaliera Universitaria Senese Viale Bracci, 14
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0577-586326
    B.5.5Fax number+39 0577-586303
    B.5.6E-mailsegreteria@fondazionenibit.org
    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 nameTremelimumab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 nameMEDI4736
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    UNRESECTABLE MALIGNANT MESOTHELIOMA
    MESOTELIOMA MALIGNO NON RESECABILE
    E.1.1.1Medical condition in easily understood language
    UNRESECTABLE MALIGNANT MESOTHELIOMA
    MESOTELIOMA MALIGNO NON RESECABILE
    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 PT
    E.1.2Classification code 10027406
    E.1.2Term Mesothelioma
    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 estimate the immune-related (ir)-ORR (proportion of subjects with complete response [CR] or partial Response [PR]) according to the ir-modified-RECIST or ir-RECIST 1.1 in pleural or peritoneal subjects, respectively.
    Valutare il tasso di risposte obbiettive immuno-correlate (percentuale di soggetti che raggiunge una risposta obbiettiva completa, o una risposta obbiettiva parziale) secondo i criteri RECIST modificati immuno-correlati, o RECIST 1.1. immuno-correlati, nei soggetti con mesotelioma pleurico o peritoneale, rispettivamente.
    E.2.2Secondary objectives of the trial
    1) To estimate the ir-Disease Control Rate (DCR) (proportion of subjects with ir-CR, ir-PR, ir-stable disease) according to the ir-modified-RECIST or ir-RECIST 1.1 in pleural or peritoneal subjects, respectively;
    2) To estimate the DCR according to the modified RECIST or RECIST 1.1 in pleural or peritoneal subjects, respectively;
    3) To estimate the ir-progression free survival (PFS) according the ir-modified-RECIST or ir-RECIST 1.1 in pleural or peritoneal subjects, respectively;
    4) To estimate the PFS according the modified-RECIST and RECIST 1.1 in pleural or peritoneal subjects, respectively;
    5) To estimate the overall survival (OS) in treated subjects;
    6) To estimate the ir-ORR, ir-DCR, ir-PFS, OS based on the PD-L1 status of tumor tissue
    7) To assess safety and tolerability of the combination regimen according to NCICTCAE V. 4.0 in treated subjects
    1) Valutare il tasso di controllo di malattia (percentuale di soggetti che raggiunge una risposta obbiettiva completa, o una risposta obbiettiva parziale, o una stabilità di malattia) secondo i criteri RECIST modificati immuno-correlati.
    2) Valutare il tasso di controllo di malattia (percentuale di soggetti che raggiunge una risposta obbiettiva completa, o una risposta obbiettiva parziale, o una stabilità di malattia) secondo i criteri RECIST modificati.
    3) Valutare la sopravvivenza libera da malattia secondo i criteri RECIST modificati immuno-correlati
    4) Valutare la sopravvivenza libera da malattia secondo i criteri RECIST modificati
    5) Valutare la sopravvivenza globale nei soggetti trattati;
    6) Valutare il tasso di risposta obbiettiva, controllo della malattia e progressione di malattia immuno-correlati, sopravvivenza globale, in base alla espressione di PD-L1 sul tessuto tumorale;
    7) Valutare la sicurezza e la tollerabilità della combinazione nei soggetti con mesotelioma
    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: A) To investigate changes in the phenotypic profile of PBMC and the frequency of selected PBMC subsets
    B) To investigate the frequency of myeloid-derived suppressor cells and T-regulatory cells
    C) To investigate changes in the levels of soluble(s)-PD-L1, sICOS, sCD25
    D) To investigate humoral response
    E) To investigate prognostic and predictive role of distinct key immune molecules in tumor tissue
    F) To assess the antigenic profile that can efficiently elicit anti-tumor T cell responses in patients undergoing the combination treatment.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: A) Valutare le modificazioni fenotipiche dei linfociti circolanti e la frequenza di selezionate sottopopolazioni linfocitarie indotte dal trattamento
    B) Valutare la frequenza di cellule mieloidi-soppressorie e delle cellule T regolatorie indotte dal trattamento
    C) Valutare variazioni dei livelli sierici della forma solubile di PD-L1, ICOS, CD25 indotte dal trattamento
    D) Valutare l’induzione o l’aumento della risposta anticorpale nel corso del trattamento
    E) Valutare il ruolo prognostico e/o predittivo di differenti molecole immunologiche nel tessuto tumorale
    F) Valutare l’induzione della risposta T cellulare nel corso del trattamento
    E.3Principal inclusion criteria
    ¿ Histologically or cytologically confirmed pleural or peritoneal malignant mesothelioma.
    ¿ Subjects who have refused a first line approved chemotherapy, or subjects in progression of disease after a maximum of one line of platinum-based therapy for advanced disease.
    ¿ Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment according to the modified RECIST for pleural mesothelioma or RECIST version 1.1 for peritoneal mesothelioma.
    ¿ Disease not amenable to curative surgery
    ¿ Age 18 and over at the time of consent
    ¿ ECOG Performance status of 0 or 1
    ¿ Life expectancy > 12 weeks
    ¿ Negative screening test results for human immunodeficiency virus (HIV), hepatitis B and C. If positive results are not indicative of true active or chronic infection, the subjects can enter the study.
    ¿ Adequate bone marrow, hepatic and renal function determined within 14 days prior to start treatment
    ¿ Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: =60 years old and no menses for ¿1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry. In addition, they must refrain from egg donation for 180 days after the final dose of investigational product.
    ¿ Nonsterilized males who are sexually active with a female partner of childbearing potential
    must use a highly effective method of contraception from Days 1 through 180 post last dose.
    In addition, they must refrain from sperm donation for 180 days after the final dose of
    investigational product.

    ¿ Subject must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution.

    ¿ Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

    Diagnosi istologica o citologica confermata di mesotelioma maligno pleurico o peritoneale.
    ¿ Soggetti con mesotelioma maligno che hanno rifiutato un trattamento medico sistemico chemioterapico di prima linea basato su un derivato del platino, o soggetti in progressione durante o dopo solo una linea di terapia medica sistemica standard
    ¿ Malattia misurabile, definita come almeno 1 lesione (misurabile) che è possibile valutare accuratamente al basale (entro i 28 giorni precedenti alla somministrazione della prima dose dei farmaci sperimentali dello studio) mediante tomografia computerizzata (TC) o risonanza magnetica nucleare (MRI) ed è disponibile per ripetute valutazioni secondo i criteri RECIST modificati o RECIST 1.1. per mesotelioma pleurico o peritoneale, rispettivamente.
    ¿ Malattia non candidabile a chirurgia con intento radicale.
    ¿ Età > 18 anni al tempo del consenso informato.
    ¿ ECOG Performance status di 0 o 1.
    ¿ Attesa di vita > 12 settimane.
    ¿ Test di screening negativi per virus da immunodeficienza acquisita, epatite B e C. Soggetti con risultati positivi ma non indicativi di infezione attiva o cronica potranno essere eleggibili.
    ¿ Adeguati parametri di funzionalità midollare, epatica e renale entro 14 giorni prima l’inizio del trattamento
    Soggetti di sesso femminile non devono essere fertili (cioè devono essere in epoca post-menopausale valutata come: età =60 anni con assenza di ciclo mestruale per oltre un anno in assenza di una causa medica; o storia di isterectomia o di legatura delle tube uterine o di ovariectomia bilaterale; o test sierico di gravidanza negativo prima di entrare nello studio. Inoltre, devono astenersi dal donare ovuli per tutta la durata dello studio fino a 180 giorni dopo l’ultima dose dei farmaci sperimentali.
    ¿ Soggetti di sesso maschile che sono sessualmente attivi con una partner potenzialmente in grado di avere gravidanze devono adottare metodi altamente efficaci di contraccezione dal giorno 1 del trattamento fino a 180 giorni dopo l’ultima dose. Inoltre, devono astenersi dal donare sperma per tutta la durata dello studio fino a 180 giorni dopo l’ultima dose dei farmaci sperimentali.
    ¿ Soggetti devono essere in grado di fornire il consenso informato scritto, e lo studio deve essere approvato dal Comitato Etico locale.
    ¿ Soggetti devono essere in grado di seguire le procedure del protocollo per tutta la durata dello studio compreso il trattamento e visite programmate durante il periodo di trattamento e nel follow-up.
    E.4Principal exclusion criteria
    ¿ Involvement in the planning and/or conduct of the study.
    ¿ Participation in another clinical study with an investigational product during the last 6 weeks
    ¿ Any previous treatment with a CTLA4, PD-1 or PD-L1 inhibitor, including tremelimumab or MEDI4736.
    ¿ History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease =3 years before the first dose of study drug and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ.
    ¿ Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) = 6 weeks prior to the first dose of study drug
    ¿ Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Bazett’s Correction
    ¿ Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
    ¿ Any unresolved toxicity (CTCAE grade >2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)
    ¿ Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
    ¿ Active or prior documented autoimmune disease or inflammatory disorders (including inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis), diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome) within the past 2 years NOTE: Subjects with vitiligo, alopecia Grave’s disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded.
    ¿ History of primary immunodeficiency
    ¿ History of allogeneic organ transplant
    ¿ History of hypersensitivity to MEDI4736 or tremelimumab or any excipient
    ¿ Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
    ¿ Known history of previous clinical diagnosis of tuberculosis
    ¿ History of leptomeningeal carcinomatosis
    ¿ Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving tremelimumab and MEDI4736.
    ¿ Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
    ¿ Subjects with uncontrolled seizures.
    Coinvolgimento nella pianificazione o conduzione dello Studio.
    ¿ Partecipazione in un altro studio clinico con un altro farmaco sperimentale nelle ultime 6 settimane.
    ¿ Precedente trattamento con inibitori di CTLA4, PD1, o PD-L1, compreso tremelimumab o MEDI4736.
    ¿ Storia di un’altra neoplasia maligna eccetto: neoplasia trattata con intento curativo, assenza di malattia negli ultimi 3 anni prima della prima dose di farmaco sperimentale, basso potenziale di recidiva/ripresa di malattia. Tumori cutanei non melanoma o lentigo maligna senza evidenza di malattia. Carcinoma in situ senza evidenza di malattia, ad esempio carcinoma della cervice uterina in situ.
    Aver ricevuto l’ultima dose di un farmaco antineoplastico (chemioterapico, immunoterapico, ormonale, agente biologico, emobolizzazione, anticorpo monoclonale, altri agenti sperimentali) = 6 settimane precedenti la prima dose di farmaco sperimentale nel presente studio.
    ¿ Media intervallo QT corretto per frequenza cardiaca (QTc) =470 ms calcolata da 3 elettrocardiogrammi (ECGs) usando il metodo di correzione di Bazett.
    ¿ Concomitante o precedente uso di farmaci immunosoppressori nei 28 giorni precedenti alla prima infusione di tremelimumab e MEDI4736, con l’eccezione di cortisonici intranasali o inalatori, o sistemici a dosi fisiologiche, con dosaggi che non superino i 10 mg/day of prednisone, o un equivalente corticosteroide.
    ¿ Qualsiasi tossicità non risolta (CTCAE grade >2) da una precedente terapia antineoplastica. Soggetti con tossicità irreversibile per la quale non è ragionevole attendersi una esacerbazione della sintomatologia da parte del farmaco sperimentale possono essere eleggibili (es., perdita di capelli, neuropatia periferica)
    ¿ Qualsiasi precedente tossicità di grado >3 considerato evento avverso immunologicamente correlato (irAE) durante il trattamento con un precedente agente immunoterapico, o un non risolto evento >Grade 1.
    ¿ Malattia autoimmune attiva o documentata precedentemente, o disordine infiammatorio (incluso malattia infiammatoria intestinale (cioè., morbo di Crohn, retto colite ulcerosa), diverticulite (con l’eccezione di diverticolosi, mobo celiaco, sindrome dell’intestino irritabile; sindrome di Wegener) negli ultimi due anni. NOTA: soggetti con vitiligo, alopecia, malattia di Grave, o psoriasi non richiedente trattamento sistemico (negli ultimi 3 anni) non sono esclusi dallo studio.
    ¿ Storia di immunodeficienza primaria.
    ¿ Storia di trapianto d’organo allogenico.
    ¿ Storia di ipersensibilità a tremelimumab o MEDI4736 o ad un eccipiente.
    ¿ Malattia intercorrente non controllata incluso, ma non limitata, a infezioni in corso o attive, insufficienza cardiaca congestizia, ipertensione non controllata, angina pectoris instabile, aritmia cardiaca , ulcera peptica attiva o gastrite attiva, diatesi emorragica attiva incluso qualsiasi soggetto noto avere evidenza di epatite acuta B,C, o HIV, o situazioni sociali/malattie psichiatriche che possono limitare la compliance del soggetto allo studio, o compromessa abilità del soggetto a fornire il consenso informato scritto.
    ¿ Storia nota di precedente diagnosi di tubercolosi
    Storia di carcinosi leptomeningea
    ¿ Aver ricevuto un vaccino con un agente microbiologico vivo attenuato nei 30 giorni dall’inizio del trattamento con tremelimumab e MEDI4736.
    ¿ Lesioni encefaliche sintomatiche o non stabilizzate che richiedono trattamento concomitante, incluso ma non limitato a chirurgia, radioterapia, e/o steroidi.
    ¿ Soggetti con epilessia non controllata.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the objective response rate (ORR) is defined as the proportion of subjects with confirmed CR or PR based on ir-modified RECIST criteria for pleural mesothelioma and ir-RECIST criteria v 1.1 for peritoneal mesothelioma.
    L'endpoint primario è il tasso di risposta obiettiva (ORR) ed è definito come la percentuale di soggetti con confermata CR o PR in base ai criteri RECIST ir-modificati per il mesotelioma pleurico e ir-RECIST v 1.1 per il mesotelioma peritoneale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 weeks
    60 settimane
    E.5.2Secondary end point(s)
    1) Ir-Disease control rate (DCR) is defined as the proportion of subjects with best response of ir-CR, ir-PR, or ir-SD, ; DCR is defined as the proportion of subjects with best response of CR, PR, or SD will be evaluated according to the modified RECIST criteria ; The ir-Progression-free-survival (ir-PFS) will be measured from the enrollment in the study to the documentation of confirmed disease progression based on the ir-modified RECIST criteria ; The PFS will be measured from the enrollment in the study to the documentation of disease progression according to the modified RECIST criteria for pleural mesothelioma and RECIST criteria v 1.1 for peritoneal mesothelioma, or death due to any cause, whichever occurs first; The OS is defined as the time from enrolment in the study until death due to any cause. ; 6) Ir-ORR, ir-DCR, ir-PFS, DCR, PFS, OS will be evaluated based on PD-L1 tumor tissue status.
    Valutare il tasso di controllo di malattia (percentuale di soggetti che raggiunge una risposta obbiettiva completa, o una risposta obbiettiva parziale, o una stabilità di malattia) immuno correlata; Valutare il tasso di controllo di malattia (percentuale di soggetti che raggiunge una risposta obbiettiva completa, o una risposta obbiettiva parziale, o una stabilità di malattia) secondo i criteri RECIST modificati; la sopravvivenza libera da malattia sarà misurata dall'arruolamento nello studio alla progressione confermata della malattia sulla base dei criteri RECIST ir modificati; La PFS sarà misurata dall'arruolamento nello studio alla progressione documentata della malattia secondo i criteri RECIST modificati, per mesotelioma pleurico e RECIST criteri V 1.1 per il mesotelioma peritoneale, o alla morte per qualsiasi causa, a seconda di quale si verifica per primo; La OS è definita come il tempo dall'arruolamento nello studio fino alla morte per qualsiasi causa.; 6) Ir-ORR, ir-DCR, ir-PFS, DCR, PFS, OS saranno valutate sulla base dello stato di PD-L1 del tessuto tumorale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 weeks; 60 weeks; 60 weeks; 60 weeks; 120 weeks; 120 weeks
    60 settimane; 60 settimane; 60 settimane; 60 settimane; 120 settimane
    ; 120 settimane
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    At study treatment completion, the subject must undergo end of treatment procedures. The end of treatment procedures include a physical examination, clinical laboratory investigations (chemistry and hematology), urine pregnancy testing, Thyroid function tests, adverse event assessment and tumor assessment (only for non progressing subjects during treatment period).
    Al termine del trattamento sperimentale, il soggetto deve sottoporsi alle procedure di fine di trattamento. Le procedure di fine trattamento includono un esame obiettivo, indagini di laboratorio cliniche (chimica ed ematologia), test di gravidanza su urine, test di funzionalità tiroidea, la valutazione degli eventi avversi e della malattia (solo per i pazienti non andati in progressione durante il trattamento).
    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 Decision2015-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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