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    Summary
    EudraCT Number:2017-003680-35
    Sponsor's Protocol Code Number:1652-CLTF
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-20
    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 ConcernedSpain - AEMPS
    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)
    Ensayo en fase II de atezolizumab (anti-PD-L1) en el tratamiento de pacientes con micosis fungoide/síndrome de Sézary en estadio IIb-IV, recidivante/resistente después de un tratamiento sistémico previo (PARCT)
    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
    Ensayo clínico para valorar eln atezolizumab (anti-PDL1) como opción de tratamiento para pacientes con micosis fungoide/syndrome de sézary que han progresado durante o tras una terapia previa.
    A.3.2Name or abbreviated title of the trial where available
    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 SponsorEuropean Organisation for Research and Treatment of Cancer (EORTC)
    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 organisationEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointClinical Operations Unit
    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 number003227741045
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.4Pharmaceutical 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 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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)
    Subtipos de linfoma cutáneo de células T (LCCT): Micosis fungoide y Síndrome de Sézary
    E.1.1.1Medical condition in easily understood language
    Cutaneous T cell lymphoma
    Linfoma cutáneo de células T
    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 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 PT
    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 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 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 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 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 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 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 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.1.3Condition 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
    El objetivo principal es determinar la actividad antitumoral de atezolizumab en pacientes con estadios avanzados resistentes o recidivantes de micosis fungoide y síndrome de Sézary, evaluados en cuanto a la tasa de respuesta global (TRG), la proporción de pacientes que logran una respuesta completa (RC) o respuesta parcial (RP), de acuerdo con los criterios de EORTC-ISCL-USCLC.
    E.2.2Secondary objectives of the trial
    Not applicable, as the trial has no secondary objectives.
    No se aplica ya que este studio no tiene objetivos secundarios.
    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-2α 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
    -Hombres o mujeres con diagnóstico de linfoma cutáneo de células T (LCCT) (micosis fungoide o síndrome de Sézary) en estadio IIB a IVB.
    -Envío obligatorio de una muestra tumoral para evaluar la expresión de PD-L1. Se recomienda una biopsia en sacabocados de 4 mm fijada en formol.
    -Respuesta inadecuada o fracaso terapéutico secundario a, como mínimo, 1 tratamiento sistémico previo para LCCT de acuerdo con las guías de tratamiento (p. ej., INF-2α o bexaroteno).
    -Edad ≥18 años.
    -Estado general según la OMS de 0-1.
    -Función orgánica y de la médula ósea adecuadas antes de recibir la primera dosis del tratamiento del estudio:
    -Hemoglobina >10,0 g/dl (>100 g/l) o hematocrito >30 % (>0,30 v/v).
    -Recuento de glóbulos blancos >3,0 x 10E9/l (>3000/mmE3).
    -Recuento absoluto de neutrófilos ≥1,5 x 10E9/l (≥1500/mmE3).
    -Recuento de plaquetas >100 x 10E9/l (≥100 000/mmE3).
    -Aclaramiento de creatinina calculado >40 ml/min según la fórmula de Cockcroft Gault o creatinina sérica menor de 1,5 veces el límite superior de la normalidad (LSN).
    -Valores de aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) menores de 2 veces el límite superior de la normalidad (LSN).
    -Bilirrubina sérica total ≤ 1,5 x LSN.
    -Podrá incluirse a pacientes con sospecha de enfermedad de Gilbert que presenten un nivel de bilirrubina sérica de ≤ 3 veces el LSN.
    -Función cardíaca clínicamente normal según el ECG de 12 derivaciones sin anomalías clínicamente relevantes y el límite inferior de la normalidad de la institución para la fracción de eyección del ventrículo izquierdo evaluada mediante ventriculografía isotópica o ecografía cardíaca.
    -Las mujeres en edad fértil (MEF) deben obtener una prueba de embarazo en suero negativa dentro de las 72 horas previas a la primera dosis del tratamiento del estudio.
    Nota: las mujeres en edad fértil se definen como mujeres premenopáusicas con capacidad para quedarse embarazadas (es decir, mujeres que han tenido signos de menstruación en los últimos 12 meses, con la excepción de las sometidas a histerectomía previa). Sin embargo, las mujeres con amenorrea en los 12 meses previos o más se siguen considerando en edad fértil si la amenorrea puede deberse a quimioterapia previa, a antiestrógenos, al bajo peso corporal, a supresión ovárica o a otros motivos.
    -Las pacientes en edad fértil/con capacidad reproductiva deben utilizar métodos anticonceptivos adecuados, de acuerdo con lo definido por el investigador, durante el periodo de tratamiento del estudio y durante al menos 5 meses después de la última dosis de tratamiento. Un método anticonceptivo altamente eficaz se define como aquel que tiene una baja tasa de fallo (es decir, inferior al 1 % anual) cuando se usa de manera sistemática y correcta. Dichos métodos incluyen:
    -anticonceptivo hormonal combinado (con estrógeno y progestágeno) asociado a una inhibición de la ovulación (oral, intravaginal o transdérmico);
    -anticonceptivo hormonal solo con progestágeno asociado a una inhibición de la ovulación (oral, inyectable, implantable);
    -dispositivo intrauterino (DIU);
    -sistema de liberación intrauterino (SLI);
    -ligadura de trompas;
    -pareja vasectomizada;
    -abstinencia sexual (la fiabilidad de la abstinencia sexual tiene que evaluarse en relación con la duración del ensayo clínico y el estilo de vida habitual y preferido de la paciente).
    -Las pacientes que estén en periodo de lactancia deben interrumpirlo antes de la primera dosis del tratamiento del estudio y hasta 6 meses después del último tratamiento del estudio.
    -Antes del registro del paciente, se debe otorgar el consentimiento informado por escrito conforme a las ICH/BPC y a la normativa nacional/local.
    E.4Principal exclusion criteria
    -Patients for whom only local therapy is indicated
    -Received chemotherapy or targeted small molecule therapy within 4 weeks prior to registration
    -Persistence of clinically relevant therapy-related toxicity from previous systemic treatment. Grade 1 or 2 adverse events (AEs) are acceptable.
    -Received a T cell depleting antibody (e.g. Alemtuzumab) within 3 months 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 (CNS) 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 6 months prior to registration:
    Unstable angina.
     Clinically significant cardiac arrhythmias.
     Myocardial infarction.
    -Have current or recent (past 6 months) history of severe, progressive, or uncontrolled renal, hepatic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
    -Severe infection within 4 weeks 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 (more than one episode of) localized, dermatomal herpes zoster.
    -Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Any live, attenuated vaccine (e.g. FluMist®) is prohibited while the patient is receiving atezolizumab and for a period of 90 days after discontinuation of atezolizumab. Inactivated influenza vaccines are allowed only during flu season.
    -Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, 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 (e.g., patients with psoriatic arthritis are excluded) 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 (test to be performed within 21 days of registration)
    -Has known active Hepatitis B or Hepatitis C.
    -Note: patient will be eligible if Negative hepatitis B surface antigen (HBsAg) test at screening
    -Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
    -Has immunodeficiency or is on systemic steroid / immunosuppressive therapy within 7 days of registration.
    -Note: systemic corticosteroids at doses ≤ 10 mg/day of prednisone or its equivalent is permitted
    -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 (TB).
    -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
    -Recepción de quimioterapia o terapia dirigida de molécula pequeña en las 4 semanas previas al registro
    -Persistencia de toxicidad relacionada con el tratamiento, de importancia clínica, debida al tratamiento sistémico previo. Los acontecimientos adversos (AA) de grado 1 o 2 son aceptables.
    -Recepción de un anticuerpo eliminador de linfocitos T (p. ej., Campath) en los 3 meses previos a la primera dosis de atezolizumab.
    -Tratamiento previo con anti-PD1, anti-PD-L1, anti-PD-L2.
    -Antecedentes de otra neoplasia maligna en los últimos 5 años, a excepción del carcinoma cervicouterino in situ y el cáncer de piel no melanoma y no metastásico que hayan sido tratados.
    -Pacientes con afectación conocida del sistema nervioso central (SNC) con linfoma
    -Antecedentes de reacciones alérgicas/anafilácticas graves a anticuerpos quiméricos, humanos o humanizados o proteínas de fusión
    -Hipersensibilidad conocida a productos de células CHO o a cualquier componente de la formulación de atezolizumab
    -Antecedentes de cualquiera de las siguientes afecciones cardiovasculares en los 6 meses previos a la primera dosis del tratamiento del estudio:
    -Angina inestable
    -Arritmias cardíacas clínicamente significativas.
    -Infarto de miocardio
    -Presencia o antecedentes recientes (últimos 6 meses) de enfermedad renal, hepática, gastrointestinal, metabólica,
    endocrina, pulmonar, cardiovascular o neurológica grave, progresiva o incontrolada
    -Infección grave en las 4 semanas anteriores al registro, lo que incluye, entre otras, la hospitalización debida a complicaciones de la infección, bacteriemia o neumonía grave
    -Presencia de signos activos de herpes zóster diseminado o herpes simple diseminado, o un herpes zoster recurrente (más de un episodio) aunque sea localizado en un dermatomo
    -Administración de una vacuna viva atenuada en las 4 semanas previas al día 1 del ciclo 1 o previsión de que, durante el estudio, será necesaria alguna vacuna viva atenuada. Queda prohibida la administración de cualquier vacuna viva atenuada (p. ej., FluMist®) mientras el paciente esté recibiendo atezolizumab y durante un periodo de 5 meses después de la interrupción de atezolizumab. Las vacunas antigripales inactivadas están permitidas solamente durante la época de gripe
    -Presencia o antecedentes de enfermedad autoinmune o inmunodeficiencia, lo que incluye, entre otras, miastenia grave, miositis, hepatitis autoinmunitaria, lupus eritematoso sistémico, artritis reumatoide, enfermedad intestinal inflamatoria, síndrome de los anticuerpos antifosfolipídicos, granulomatosis de Wegener, síndrome de Sjögren, síndrome de Guillain-Barré o esclerosis múltiple, con las siguientes excepciones:
    -Los pacientes con antecedentes de hipotiroidismo autoinmunitario que reciben tratamiento de reemplazo de la hormona tiroidea son aptos para el estudio
    -Los pacientes con diabetes mellitus de tipo 1 controlada que reciben tratamiento de insulina son aptos para el estudio
    -Los pacientes con eccema, psoriasis, liquen simple crónico o vitíligo con solo manifestaciones dermatológicas (p. ej., se excluyen los pacientes con artritis psoriásica) son aptos para el estudio siempre y cuando se cumplan todas las condiciones siguientes:
    -La erupción cutánea debe cubrir < 10 % de la superficie corporal.
    -La enfermedad está bien controlada en el momento basal y requiere solamente corticosteroides tópicos de baja potencia
    -Ausencia de exacerbaciones agudas de la enfermedad subyacente que requieran psoraleno más radiación ultravioleta A, metotrexato, retinoides, agentes biológicos,
    inhibidores orales de la calcineurina o corticosteroides de alta potencia u orales, en los 12 meses anteriores
    -Tiene antecedentes conocidos de VIH (la prueba debe realizarse en los 21 días previos al registro)
    -Tiene hepatitis B o hepatitis C activa conocida.El paciente será apto en caso de:
    -resultado negativo de la prueba del antígeno de superficie de la hepatitis B (HBsAg) en la selección;
    -resultado negativo en la prueba de anticuerpo del núcleo de la hepatitis B (HBcAb) total en la selección, o resultado positivo de HBcAb total seguido de un resultado negativo en la prueba de ADN del virus de la hepatitis B (VHB) en la selección. La prueba de ADN del VHB se llevará a cabo solamente en pacientes que obtengan un resultado positivo para la prueba de HBcAb total
    -Tiene inmunodeficiencia o recibe tratamiento sistémico esteroide/inmunosupresor en los 7 días previos a la primera dosis de atezolizumab.Se permiten los corticosteroides sistémicos en dosis de ≤10 mg/día de prednisona o su equivalente
    -Presencia o antecedentes de neumonitis no infecciosa que requiere esteroides o de fibrosis pulmonar
    -Tiene antecedentes o indicios presentes de alguna afección, tratamiento o anomalía analítica que podría causar confusión en los resultados del ensayo, o interferir en la participación del paciente.
    -Signos de infección activa o latente o tratada inadecuadamente de Mycobacterium tuberculosis (TB)
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response (CR+PR) rate (EORTC-ISCL-USCLC criteria)
    Tasa de mejor respuesta global (RC+RP) (criterios EORTC-ISCL-USCLC).
    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
    La tasa de respuesta global se cuenta desde la inclusión del paciente hasta un máximo de un año de tratamiento.
    E.5.2Secondary end point(s)
    -Progression free survival (PFS), according to EORTC-ISCL-USCLC criteria
    -Overall survival (OS)
    -Time to response (CR/PR)
    -Duration of response
    -Time to next systemic treatment
    -Evaluate safety and tolerability in this patient population
    -Supervivencia sin progresión (criterios EORTC-ISCL-USCLC)
    -Supervivencia global (SG)
    -Tiempo hasta la respuesta (RC/RP)
    -Duración de la respuesta
    -Tiempo hasta el siguiente tratamiento sistémico
    -Evaluar la seguridad y tolerabilidad en este grupo de pacientes
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PFS is counted from patient registration until disease progression
    -OS is counted from patient registration until the date of death from any cause
    -Time to response (CR/PR) is counted from patient registration until CR/PR or disease progression
    -Duration of response is counted from the date of CR/PR till disease progression
    -Time to next systemic treatment is counted from patient registration up to up to next systemic treatment received
    -Evaluate safety and tolerability in this patient population is counted from patient registration until 3 months after treatment discontinuation
    -La Supervivencia Sin Progresión se cuenta desde el registro del paciente hasta la progresión de la enfermedad
    -La supervivencia global (SG) se define como el tiempo transcurrido desde el registro del paciente hasta la fecha de la muerte por cualquier causa
    -El tiempo hasta la respuesta (RC/RP) se cuenta desde el registro del paciente hasta RC/RP o progresión de la enfermedad
    -La duración de respuesta se cuenta desde la fecha de (RC/RP) hasta la progresión de la enfermedad
    -El tiempo hasta el siguiente tratamiento sistémico se cuenta desde la inclusión del paciente hasta que se recibe el siguiente tratamiento sistémico
    -La evaluación de la seguridad y tolerabilidad del paciente se cuenta desde la inclusión del paciente hasta 3 meses después de la descontinuación del tratamiento
    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 Yes
    E.8.1.7.1Other trial design description
    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 EEA14
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 29
    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
    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 Decision2018-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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