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    Summary
    EudraCT Number:2017-003680-35
    Sponsor's Protocol Code Number:1652-CLTF
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003680-35
    A.3Full title of the trial
    Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment (PARCT)
    Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapy
    Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapy
    A.3.2Name or abbreviated title of the trial where available
    PARCT
    PARCT
    A.4.1Sponsor's protocol code number1652-CLTF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03357224
    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 SponsorEORTC AISBL/IVZW
    B.1.3.4CountryBelgium
    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 Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEORTC
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Emanuel Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number003227741074
    B.5.5Fax number003227727063
    B.5.6E-mailregulatory@eortc.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 Yes
    D.2.1.1.1Trade name Tecentriq (Marketing Authorisation No: EU/1/17/1220/001)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH (RRG), Grenzach, Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current 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.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
    Subtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)
    Subtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)
    E.1.1.1Medical condition in easily understood language
    Cutaneous T cell lymphoma
    Cutaneous T cell lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028508
    E.1.2Term Mycosis fungoides/Sezary syndrome
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10040785
    E.1.2Term Skin and subcutaneous tissue disorders
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10040790
    E.1.2Term Skin and subcutaneous tissue disorders NEC
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028484
    E.1.2Term Mycoses fungoides
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10042356
    E.1.2Term Skin and subcutaneous conditions NEC
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028483
    E.1.2Term Mycosis fungoides
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10040790
    E.1.2Term Skin and subcutaneous tissue disorders NEC
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025321
    E.1.2Term Lymphomas non-Hodgkin's T-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028508
    E.1.2Term Mycosis fungoides/Sezary syndrome
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025321
    E.1.2Term Lymphomas non-Hodgkin's T-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028483
    E.1.2Term Mycosis fungoides
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10042356
    E.1.2Term Skin and subcutaneous conditions NEC
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028484
    E.1.2Term Mycoses fungoides
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the antitumor activity of atezolizumab for patients with refractory or relapsed advanced stages of mycosis fungoides and Sézary syndrome, assessed in terms of the overall response rate, according to EORTC-ISCL-USCLC criteria
    Determinare l’attività antitumorale di atezolizumab in pazienti affetti da micosi fungoide in fase avanzata e sindrome di Sézary refrattari o recidivanti, valutata in termini di tasso di risposta complessiva (ORR) e percentuale di pazienti che raggiungono una risposta completa (CR) o una risposta parziale (PR), in base ai criteri EORTC-ISCL-USCLC.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female patients with diagnosis of CTCL (mycosis fungoides or Sézary-Syndrome) tumor stage IIB to IVB (Ref. 12)
    -Availability of tumor sample for evaluation of PD-L1 expression. A 4-mm formalin-fixed punch biopsy is recommended.
    -Inadequate response or secondary treatment failure to at least 1 prior systemic therapy for CTCL according to treatment guidelines (e.g. INF-2a or bexarotene).
    ¿ Age = 18 years old
    ¿ WHO performance status 0-1
    ¿ Adequate bone marrow and organ function within 14 days prior registration:
    ¿ Hemoglobin > 10.0 g/dL (> 100 g/L) or hematocrit > 30% (> 0.30 v/v);
    ¿ White blood cell count > 3.0 x 10E9/L (> 3000/mmE3);
    ¿ Absolute neutrophil count of > 1.5 x 10E9/L (> 1500/mmE3);
    ¿ Platelet count > 100 x 10E9/L (> 100,000/mmE3);
    ¿ Estimated creatinine clearance > 40 mL/min based on the Cockcroft Gault calculation or serum creatinine less than 1.5 times the upper limit of normal (ULN)
    ¿ Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values less than 2 times the upper limit of normal (ULN)
    ¿ Serum total bilirubin = 1.5 x ULN
    ¿ Patients with suspicion of Gilbert disease who have serum bilirubin level =3 x ULN may be enrolled.
    -Clinically normal cardiac function based on 12 lead ECG without clinically relevant abnormalities and the institutional lower limit of normal for left ventricular ejection fraction as assessed either by multi-gated acquisition scan or cardiac ultrasound.
    -Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
    Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior
    chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons.
    -Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 5 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
    ¿ Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    ¿ Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    ¿ Intrauterine device (IUD)
    ¿ Intrauterine hormone-releasing system (IUS)
    ¿ Bilateral tubal occlusion
    ¿ Vasectomized partner
    ¿ Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
    -Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
    -Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
    • Pazienti di sesso maschile e femminile con diagnosi di linfoma cutaneo a cellule T (CTCL) (micosi fungoide o sindrome di Sézary) in fase avanzata da IIB-IVB
    • È richiesto l’invio un campione tumorale per la valutazione dell’espressione di PD-L1. Si raccomanda una biopsia punch di 4 mm fissata in formalina.
    • Risposta inadeguata o fallimento di un trattamento secondario ad almeno 1 precedente terapia sistemica per il CTCL sulla base delle linee guida per il trattamento (ad es., INF-2a o bexarotene).
    • Età =18 anni
    • Stato di validità secondo l’OMS 0-1
    • Adeguata funzione midollare e organica prima di ricevere la prima dose di trattamento dello studio:
    • Emoglobina >10,0 g/dl (>100 g/l) o ematocrito >30% (>0,30 v/v);
    • Conta leucocitaria >3,0 x 10E9/l (>3000/mmE3);
    • Conta assoluta dei neutrofili >1,5 x 10E9/l (>1500/mmE3);
    • Conta piastrinica >100 x 10E9/l (>100.000/mmE3);
    • Clearance stimata della creatinina >40 ml/min calcolata in base alla formula di Cockcroft-Gault o creatinina sierica inferiore a 1,5 volte il limite superiore della norma (ULN);
    • Valori di aspartato aminotransferasi (AST) e/o alanina aminotransferasi (ALT) inferiori a 2 volte il limite superiore della norma (ULN)

    • Bilirubina sierica totale =1,5 x ULN
    • I pazienti con sospetto di malattia di Gilbert con un livello di bilirubina sierica >3 x ULN possono essere arruolati.
    • Funzione cardiaca clinicamente nella norma come evidenziato da un ECG a 12 derivazioni che non presenti anomalie clinicamente rilevanti e dal limite inferiore istituzionale della norma per la frazione di eiezione del ventricolo sinistro in base a valutazioni tramite scansione con acquisizione a gate multipli o ecocardiogramma.
    • Le donne in età fertile (WOCBP) devono presentare un test di gravidanza sul siero negativo nelle 72 ore precedenti la prima dose di trattamento dello studio.
    • Nota: si definiscono donne in età fertile i soggetti di sesso femminile in premenopausa in grado di intraprendere una gravidanza (ossia donne con qualsiasi evidenza di mestruazioni nei 12 mesi precedenti, eccetto se precedentemente sottoposte a isterectomia). Tuttavia, le donne amenorroiche per 12 o più mesi sono comunque considerate in età fertile se l’amenorrea è potenzialmente dovuta a precedente chemioterapia, antiestrogeni, basso peso corporeo, soppressione ovarica o altri motivi.
    • I pazienti in età fertile/con potenziale riproduttivo devono utilizzare misure di contraccezione adeguate, come definite dallo sperimentatore, durante il periodo di trattamento dello studio e per almeno 5 mesi dopo l’ultima dose di trattamento. È definito altamente efficace un metodo contraccettivo che comporti un ridotto tasso d’insuccesso (ovvero, inferiore all’1% all’anno), se utilizzato regolarmente e correttamente. Tali metodi comprendono:
    • Contraccezione ormonale combinata (contenente estrogeni e progesterone) associata a inibizione dell’ovulazione (per via orale, intravaginale, transdermica)
    • Contraccezione ormonale a base di solo progestinico associata a inibizione dell’ovulazione (per via orale, iniettabile, impiantabile)
    • Dispositivo intrauterino (IUD)
    • Sistema intrauterino a rilascio ormonale (IUS)
    • Occlusione bilaterale delle tube
    • Compagno vasectomizzato
    • Astinenza sessuale (l’affidabilità dell’astinenza sessuale deve essere valutata in relazione alla durata della sperimentazione clinica e allo stile di vita preferito e consueto del paziente)
    • I soggetti di sesso femminile che allattano al seno devono interrompere l’allattamento prima della prima dose di trattamento dello studio e fino a 6 mesi dopo l’ultimo trattamento dello studio.
    • Prima della registrazione del paziente, deve essere fornito il consenso informato scritto conformemente agli standard di buona pratica clinica della conferenza internazionale per l’armonizzazione (ICH/GCP) e alle normative nazionali/locali.
    E.4Principal exclusion criteria
    -Patients for whom only local therapy is indicated
    -Received chemotherapy or targeted small molecule therapy within 4weeks prior to registration
    -Persistence of clinically relevant therapy-related toxicity from previous systemic treatment. Grade 1 or 2 adverse events are acceptable
    -Received a T cell depleting antibody within 3months prior to registration
    -Prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2
    -History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix and non-metastatic, non-melanoma skin cancer
    -Patients with known central nervous system involvement with lymphoma
    -History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
    -Known hypersensitivity to CHO cell products or any component of the atezolizumab formulation
    -History of any of the following cardiovascular conditions within 6months prior to registration:
    Unstable angina
    Clinically significant cardiac arrhythmias
    Myocardial infarction
    -Have current or recent (past 6months) history of severe, progressive, or uncontrolled renal, hepatic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
    -Severe infection within 4weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
    -Have active signs of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
    -Administration of a live, attenuated vaccine within 4weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Any live, attenuated vaccine is prohibited while the patient is receiving atezolizumab and for a period of 90days after discontinuation of atezolizumab. Inactivated influenza vaccines are allowed only during flu season.
    -Active or history of autoimmune disease or immune deficiency, with the following exceptions:
    Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
    Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
    Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met:
    Rash must cover <10% of body surface area
    Disease is well controlled at baseline and requires only low-potency topical corticosteroids
    -No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12months
    -Has a known history of HIV
    -Has known active Hepatitis B or Hepatitis C
    -Negative total HBcAb test at screening, or positive total HBcAb test followed by a negative HBV DNA test at screening
    -Has immunodeficiency or is on systemic steroid/immunosuppressive therapy within 7days of registration
    -Current or previous history of non-infectious pneumonitis requiring steroids, or pulmonary fibrosis
    -Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation
    -Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis
    -Regarding hematopoietic stem cell transplantation:
    Patients who had previously stem cell transplantation
    Patients that are waiting for stem cell transplantation
    -Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    -Pazienti per i quali è indicata una esclusiva terapia locale
    -Avere ricevuto chemioterapia o terapie target specifiche nelle 4 settimane precedenti la registrazione
    -Persistenza di tossicità clinicamente rilevante correlata alla terapia dovuta a precedente trattamento sistemico. Si considerano accettabili gli eventi avversi di grado 1 o 2
    -Avere ricevuto anticorpi per la deplezione delle cellule T nei 3 mesi precedenti la prima dose di atezolizumab
    -Precedente terapia con anti-PD1, anti-PD-L1, anti-PD-L2
    -Anamnesi di altro tumore maligno nei 5 anni precedenti, ad eccezione del carcinoma in situ della cervice uterina e di tumori cutanei non-melanoma non metastatici che abbiano ricevuto un adeguato trattamento
    -Pazienti con coinvolgimento noto del sistema nervoso centrale da parte del linfoma
    -Anamnesi di gravi reazioni allergiche/anafilattiche agli anticorpi chimerici, umani o umanizzati o alle proteine di fusione
    -Ipersensibilità nota alle cellule CHO o a uno qualsiasi dei componenti della formulazione di atezolizumab.
    -Anamnesi di una qualsiasi delle seguenti patologie cardiovascolari nei 6 mesi precedenti la prima dose di trattamento dello studio:
    -Angina instabile
    -Aritmie cardiache clinicamente significative
    -Infarto miocardico
    -Anamnesi attuale o recente (negli ultimi 6 mesi) di malattia renale, epatica, gastrointestinale, metabolica, endocrina, polmonare, cardiovascolare o neurologica grave, progressiva o incontrollata
    -Grave infezione nelle 4 settimane precedenti la registrazione, comprese, a titolo meramente esemplificativo ma non esaustivo, ospedalizzazione per complicanze dell’infezione, batteriemia o grave polmonite
    -Presenza di segni attivi di Herpes zoster disseminato o Herpes simplex disseminato o Herpes zoster dermatomerico localizzato ricorrente
    -Somministrazione di un vaccino vivo attenuato nelle 4 settimane precedenti il Ciclo 1, Giorno 1 o previsione della necessità di somministrare tale vaccino vivo attenuato durante lo studio. Sono proibiti tutti i vaccini vivi attenuati finché il paziente riceve atezolizumab e per un periodo di 5 mesi dopo l’interruzione di atezolizumab. I vaccini antinfluenzali inattivati sono ammessi solo durante la stagione influenzale
    -Presenza o anamnesi di malattia autoimmune o immunodeficienza compresi, con le seguenti eccezioni:
    -I pazienti con un’anamnesi di ipotiroidismo autoimmune in trattamento con ormoni di sostituzione tiroidea sono idonei allo studio
    -I pazienti con diabete mellito di Tipo 1 che seguono un regime insulinico sono idonei allo studio
    -I pazienti con eczema, psoriasi, lichen simplex cronico o vitiligine con manifestazioni solo dermatologiche sono idonei allo studio purché risultino soddisfatte tutte le seguenti condizioni:
    -L’eruzione cutanea deve coprire ¿10% di superficie corporea
    -La malattia deve essere ben controllata al basale e richiedere solo corticosteroidi topici a bassa potenza
    -Nessun episodio di esacerbazione acuta della patologia di base che richieda trattamento con psoraleni più UVA, metotressato, retinoidi, agenti biologici, inibitori orali della calcineurina o corticosteroidi ad alta potenza o orali nei 12 mesi precedenti
    -Anamnesi nota di HIV-Epatite B o epatite C attiva nota
    -Risulta negativo al test per l’antigene di superficie dell’epatite B allo screening
    -Risulta negativo al test per gli HBcAb totali allo screening o positivo al test degli HBcAb totali, seguito da un test negativo per il DNA del HBV allo screening
    -Presenta immunodeficienza o ha assunto terapia steroidea/immunosoppressiva sistemica nei 7 giorni precedenti la prima dose di atezolizumab
    -Presenza attuale o anamnesi di polmonite non-infettiva richiedente steroidi, o di fibrosi polmonare
    -Anamnesi o presenza attuale di qualsiasi condizione, terapia o anomalia di laboratorio che potrebbe alterare i risultati della sperimentazione o interferire con la partecipazione del soggetto
    -Presenza di infezione da Mycobacterium tuberculosis attiva o latente o inadeguatamente trattata
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response (CR+PR) rate (EORTC-ISCL-USCLC criteria) observed up to maximum of 1 year from patient registration.
    Miglior tasso di risposta complessiva (CR+PR) (criteri EORTC-ISCL-USCLC) osservato fino ad un massimo di 1 anno dalla registrazione del paziente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR is counted from patient registration up to a maximum of 1 year of treatment
    ORR is counted from patient registration up to a maximum of 1 year of treatment
    E.5.2Secondary end point(s)
    o Progression free survival (PFS), according to EORTC-ISCL-USCLC criteria
    o Overall survival (OS)
    o Time to response (CR/PR)
    o Duration of response
    o Time to next systemic treatment
    o Evaluate safety and tolerability in this patient population
    o Progression free survival (PFS), according to EORTC-ISCL-USCLC criteria
    o Overall survival (OS)
    o Time to response (CR/PR)
    o Duration of response
    o Time to next systemic treatment
    o Evaluate safety and tolerability in this patient population
    E.5.2.1Timepoint(s) of evaluation of this end point
    o PFS is counted from the date of treatment start to the first date of progressive disease or death from any cause.
    o OS is counted from the date of treatment start to the date of death from any cause.
    o Time to response (CR/PR) is counted from the date of treatment start until the time measurement criteria for CR/PR (whichever is first recorded) are first met.
    o Duration of response is counted from the date when criteria for CR/PR are first met till disease progression
    o Time to next systemic treatment is counted as time from the end of the current atezolizumab treatment until the time the next systemic treatment is recorded.
    o Evaluate safety and tolerability in this patient population is counted from patient registration until 3 months after treatment discontinuation
    o PFS is counted from the date of treatment start to the first date of progressive disease or death from any cause.
    o OS is counted from the date of treatment start to the date of death from any cause.
    o Time to response (CR/PR) is counted from the date of treatment start until the time measurement criteria for CR/PR (whichever is first recorded) are first met.
    o Duration of response is counted from the date when criteria for CR/PR are first met till disease progression
    o Time to next systemic treatment is counted as time from the end of the current atezolizumab treatment until the time the next systemic treatment is recorded.
    o Evaluate safety and tolerability in this patient population is counted from patient registration until 3 months after treatment discontinuation
    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 Yes
    E.8.1.7.1Other trial design description
    Single arm
    Single arm
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Austria
    France
    Germany
    Greece
    Italy
    Netherlands
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Ninety (90) days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    End of study occurs when all of the following criteria have been satisfied:
    1. Ninety (90) days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 26
    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)
    According to the discretion of the treating physician
    According to the discretion of the treating physician
    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 Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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