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    Summary
    EudraCT Number:2018-002180-25
    Sponsor's Protocol Code Number:ETOP_13-18
    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:2020-12-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002180-25
    A.3Full title of the trial
    A multicentre randomised phase III trial comparing atezolizumab plus bevacizumab and standard chemotherapy versus bevacizumab and standard chemotherapy as first-line treatment for advanced malignant pleural mesothelioma.
    Uno studio multicentrico randomizzato di fase III che mette a confronto atezolizumab più bevacizumab e la chemioterapia standard rispetto a bevacizumab e la chemioterapia standard come trattamento di prima linea per il mesotelioma pleurico maligno di stadio avanzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of atezolizumab and bevacizumab with standard chemotherapy versus bevacizumab with standard chemotherapy in treatment of the cancer called "malignant pleural mesothelioma".
    Confronto di un trattamento con atezolizumab e bevacizumab in aggiunta alla chemioterapia standard con un trattamento con bevacizumab e chemioterapia standard nel trattamento del mesotelioma pleurico.
    A.3.2Name or abbreviated title of the trial where available
    BEAT-meso
    BEAT-meso
    A.4.1Sponsor's protocol code numberETOP_13-18
    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 SponsorEUROPEAN THORACIC ONCOLOGY PLATFORM
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO EUROPEO DI ONCOLOGIA
    B.5.2Functional name of contact pointUFFICIO STUDI CLINICI ED ATTIVITA'
    B.5.3 Address:
    B.5.3.1Street AddressVIA ADAMELLO 16
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number0257489848
    B.5.6E-mailufficio.studiclinici@ieo.it
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Emil- Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAtezolizumab
    D.3.2Product code [MPDL3280A]
    D.3.4Pharmaceutical form Concentrate for 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 INNAtezolizumab
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 RoleComparator
    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 AVASTIN
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Emil- Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namebevacizumab
    D.3.2Product code [Ro4876646-000]
    D.3.4Pharmaceutical form Concentrate for 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRo4876646-000
    D.3.9.4EV Substance CodeSUB16402MIG
    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
    Advanced malignant pleural mesothelioma
    Mesotelioma pleurico maligno avanzato
    E.1.1.1Medical condition in easily understood language
    A type of lung cancer that is called "malignant pleural mesothelioma"
    Tipo di cancro definito "Mesotelioma pleurico maligno".
    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 LLT
    E.1.2Classification code 10035605
    E.1.2Term Pleural mesothelioma malignant advanced
    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 effect of atezolizumab in terms of PFS and OS when added to standard of care (carboplatin/pemetrexed/bevacizumab), as first-line treatment of advanced MPM.
    Valutare l'effetto di Atezolizumab, aggiunto alla terapia standard (carboplatin/pemetrexed/bevacizumab) in termini di PFS ed OS, come trattamento di prima linea le mesotelionma pleurico avanzato.
    E.2.2Secondary objectives of the trial
    - To evaluate secondary measures of clinical efficacy including response rate, disease control rate, time to treatment failure, duration of response.
    - To assess the safety and tolerability of the treatment.
    - To evaluate symptom-specific and global quality of life.
    - Valutare il tasso di risposta, il tasso di controllo della malattia, il tempo al fallimento del trattamento, la durata della risposta
    - Valutare la sicurezza e la tollerabilità del trattamento
    - Valutare i sintomi specifici e la qualità di vita globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed advanced malignant pleural mesothelioma (all histological subtypes are eligible)
    - Able to understand and give written informed consent and comply with trial procedures
    - Age > or equal to 18 years and < or equal to 74 anni
    - Performance Status 0-1
    - Not amenable for radical surgery based on local standards
    - Availability of tumour tissue for translational research
    - Evaluable disease or measurable disease as assessed according to the mRECIST v1.1
    - Life expectancy >3 months
    - Adequate haematological, renal and liver function (CrCl >45)
    - Completed baseline QoL questionnaire
    - Men and women of childbearing potential must agree to use adequate contraception
    - Mesotelioma pleurico maligno di stadio avanzato confermato istologicamente (tutte le sotto tipologie istologiche sono ammissibili)
    - Capacità di comprendere e fornire per iscritto il consenso informato e di rispettare le procedure dello studio
    - Età > o uguale a 18 anni e < o uguale a 74 anni
    - Status funzionale 0-1
    - Non idoneo a resezione radicale ai sensi degli standard locali
    - Disponibilità di tessuto tumorale per ricerca traslazionale
    - Patologia valutabile o misurabile ai sensi dei criteri mRECIST v1.1
    - Aspettativa di vita >3 mesi
    - Adeguata funzione ematica, renale ed epatica (CrCl >45)
    - Completamento del questionario sulla qualità della vita di baseline
    - Gli uomini e donne in età fertile devono accettare di utilizzare contraccettivi adeguati
    E.4Principal exclusion criteria
    - Prior treatment for malignant pleural mesothelioma
    - Active autoimmune disease that has required systemic treatment in past 2 years
    - Previous history of significant haemoptysis (defined as at least 2.5mL emission of red blood) in the 3 months prior to inclusion.
    - Recent surgery:
    1. Major surgery or significant traumatic injury within 28 days prior to
    inclusion.
    2. Minor surgical procedure within 7 days, or placement of a vascular
    access device within 2 days of randomisation.
    - HIV or active hepatitis B or hepatitis C
    - Active or untreated CNS metastases
    - Significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
    - Unintentional weight loss (>10% of the patient’s usual weight) in the past 3 months.
    - Precedenti trattamenti per il mesotelioma pleurico maligno
    - Malattia autoimmune attiva che abbia richiesto un trattamento sistemico negli ultimi 2 anni
    - Storia pregressa di grave emottisi (definita come almeno 2,5mL di emissioni di sangue rosso) nei 3 mesi precedenti l’inclusione.
    - Recenti interventi chirurgici:
    1. Intervento chirurgico di grande entità o grave trauma nei 28 giorni precedenti l’inclusione.
    2. Intervento chirurgico di minore entità nei 7 giorni precedenti la randomizzazione o posizionamento di un dispositivo di accesso vascolare nei 2 giorni precedenti la randomizzazione.
    - HIV, epatite B o epatite C attive
    - Metastasi al SNC attive o non trattate
    - Malattie cardiovascolari significative come malattia cardiaca classe II o maggiore secondo la New York Heart Association (NYHA), infarto del miocardio nei 3 mesi precedenti la randomizzazione, aritmie cardiache instabili o angina instabile. Pazienti con coronaropatie conosciute, insufficienza cardiaca congestiva non conforme al criterio summenzionato o con frazione di eiezione del ventricolo sinistro >50%, devono essere in costante trattamento medico ritenuto ottimale dal medico curante, in consultazione con un cardiologo, se appropriato.
    - Perdita di peso non intenzionale (>10% del peso abituale) negli ultimi 3 mesi.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) according to the mRECIST v1.1 and overall-survival (OS)
    Sopravvivenza libera da progressione, in accordo ai criteri mRECIST 1.1, e sopravvivenza complessiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    -PFS: time from the date of randomisation until documented progression or death
    -OS: time from the date of randomisation until death from any cause.
    - PFS: tempo dalla data di randomizzazione fino a progressione documentata o decesso
    - OS: tempo dalla data di randomizzazione fino al decesso per qualsiasi causa
    E.5.2Secondary end point(s)
    Response rate (OR); Disease control rate (DC); Time to treatment failure (TTF); Duration of response (DoR); Adverse events according to CTCAE v5.0
    Tasso di risposta; Tasso di controllo della malattia; Tempo al fallimento del trattamento; Durata della risposta; Eventi avversi in accordo con i criteri CTCAR v.5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the start of protocol treatment across all time points until the end of protocol treatment; At 24 weeks; Time from the date of randomisation to discontinuation of protocol treatment for any reason; Interval from the date of first documentation of objective response to the date of first documented progression or relapse.; From the date of signature of informed consent until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication.
    Dall'inizio del trattamento di studio, attraverso tutti i time points, fino alla fine del trattamento sperimentale.; A 24 settimane.; Tempo tra la data di randomizzazione fino alla discontinuazione dal protocollo per qualsiasi ragione.; Intervallo tra la data della prima risposta oggettiva al trattamento fino alla prima progressione documentata o recidiva.; Dalla data di firma del consenso informato fino a 90 giorni dopo l'ultima dose del trattamento sperimentale, indipendentemente che siano considerati correlati al farmaco o meno.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    France
    Italy
    Portugal
    Slovenia
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 320
    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)
    NA
    NA
    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 Decision2019-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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