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    Summary
    EudraCT Number:2014-004684-20
    Sponsor's Protocol Code Number:WO29637
    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:2015-03-03
    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 number2014-004684-20
    A.3Full title of the trial
    A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MPDL3280A (Anti?PD-L1 ANTIBODY) IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATEDADVANCED RENAL CELL CARCINOMA
    ESTUDIO EN FASE III, ALEATORIZADO Y ABIERTO DE MPDL3280A (ANTICUERPO antiPD L1) EN COMBINACIÓN CON BEVACIZUMAB COMPARADO CON SUNITINIB EN PACIENTES CON CARCINOMA DE CÉLULAS RENALES AVANZADO NO TRATADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study of immunotherapy combined with growth factor inhibitors
    compared to conventional sunitinib for advanced kidney cancer
    Estudio Fase 3 de inmunoterapia combinada con inhibidores del factor de crecimiento comparado con sunitinib convencional para cancer renal avanzado
    A.4.1Sponsor's protocol code numberWO29637
    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 SponsorRoche Farma S.A en nombre de F. Hoffmann-La Roche LTD
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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.3.2Product code MPDL3280A-RO5541267
    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 INNNot Yet defined
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    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.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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    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 nameBevacizumab
    D.3.2Product code RO4876646
    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
    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 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.IMP: 3
    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 Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameSunitinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUNITINIB
    D.3.9.1CAS number 557795-19-4
    D.3.9.4EV Substance CodeSUB22321
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced kidney cancer
    CARCINOMA DE CÉLULAS RENALES AVANZADO
    E.1.1.1Medical condition in easily understood language
    advanced kidney cancer
    CARCINOMA DE CÉLULAS RENALES AVANZADO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10023400
    E.1.2Term Kidney cancer
    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
    Evaluate the efficacy of MPDL3280A+bevacizumab compared with sunitinib as measured by investigator assessed progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
    Evaluar la eficacia de MPDL3280A + bevacizumab en comparación con sunitinib medida mediante la supervivencia libre de progresión (SLP) determinada por el investigador conforme a los Criterios de evaluación de la respuesta en tumores sólidos versión 1.1 (RECIST v1.1).
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of MPDL3280A + bevacizumab versus sunitinib as measured by Independent Review Committee (IRC)?assessed PFS according to RECIST v1.1
    -To evaluate the efficacy of MPDL3280A + bevacizumab versus sunitinib as measured by overall survival (OS)
    -To evaluate the efficacy of MPDL3280A +bevacizumab versus sunitinib as measured by investigator-assessed objective response rate (ORR) (complete partial response rates) per RECIST v1.1
    ?Evaluar la eficacia de MPDL3280A + bevacizumab en comparación con sunitinib medida mediante la SLP determinada por un comité de revisión independiente (CRI) conforme a los criterios RECIST v1.1
    ?Evaluar la eficacia de MPDL3280A + bevacizumab en comparación con sunitinib medida mediante la supervivencia global (SG)
    ?Evaluar la eficacia de MPDL3280A + bevacizumab en comparación con sunitinib medida mediante la tasa de respuestas objetivas (TRO) determinada por el investigador (tasas de respuesta completa + parcial) conforme a los criterios RECIST v1.1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Unresectable advanced or metastatic RCC with clear cell histology and/or sarcomatoid carcinoma (defined below)
    ?Measurable disease, as defined by RECIST v1.1
    ?Karnofsky performance status ?70
    ?Adequate hematologic and end organ function, defined by the following laboratory results obtained within 28 calendar days prior to the first study treatment:
    ANC ? 1500 cells/?L (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
    WBC counts ? 2500/?l
    Lymphocyte count ? 300/?l
    Platelet count ? 100,000/?l (without transfusion within 2 weeks prior to Cycle 1, Day 1)
    Hemoglobin ? 9.0 g/dL
    AST, ALT, and alkaline phosphatase ?2.5 x the upper limit of normal (ULN), with the following exceptions:
    Patients with documented liver metastases: AST and ALT ? 5 x ULN
    Patients with documented liver or bone metastases: alkaline phosphatase ?5 x ULN
    Serum bilirubin ?1.5 x ULN
    Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolled.
    INR and aPTT ?1.5 x ULN, unless on a stable dose of warfarin
    Serum albumin > 2.5 g/dL
    Creatinine clearance ? 30 mL/min (Cockcroft-Gault formula or based on 24 hour urine collection)
    ?CCR avanzado o metastásico irresecable con histología de células claras o carcinoma sarcomatoide (definida a continuación)
    ?Enfermedad medible, definida según los criterios RECIST v1.1
    ?Estado funcional de Karnofsky ? 70
    ?Función hematológica y de órganos diana adecuada, definida por los resultados analíticos siguientes obtenidos en los 28 días naturales previos a la administración de la primera dosis del tratamiento del estudio:
    RAN ? 1500 células/?l (sin apoyo con factor estimulador de las colonias de granulocitos en las 2 semanas previas al día 1 del ciclo 1)
    Recuento de leucocitos ? 2500/?l
    Recuento de linfocitos ? 300/?l
    Recuento de plaquetas ? 100.000/?l (sin transfusión en las 2 semanas previas al día 1 del ciclo 1)
    Hemoglobina ? 9,0 g/dl
    AST, ALT y fosfatasa alcalina ? 2,5 x el límite superior de la normalidad (LSN), con las excepciones siguientes:
    Pacientes con metástasis hepáticas documentadas: AST y ALT ? 5 x LSN
    Pacientes con metástasis hepáticas u óseas documentadas: fosfatasa alcalina ? 5 x LSN
    Bilirrubina sérica ? 1,5 x LSN
    Se podrá incluir a pacientes con síndrome de Gilbert documentado que presenten una concentración sérica de bilirrubina ? 3 x LSN.
    INR y TTPa ? 1,5 x LSN, a menos que se reciba una dosis estable de warfarina
    Seroalbúmina > 2,5 g/dl
    Aclaramiento de creatinina ? 30 ml/min (fórmula de Cockcroft Gault o basado en recogida de orina durante 24 horas)
    E.4Principal exclusion criteria
    ?No prior treatment with active or experimental systemic agents for treatment of RCC, including treatment in the neoadjuvant or adjuvant setting. Prior treatment with placebo in adjuvant setting is allowed.
    ?Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments
    ?Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated at least 14 days prior to Cycle 1, Day 1.
    ?Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    ?Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or Ca >12 mg/dL or corrected serum calcium greater than the upper limit of normal]) or symptomatic hypercalcemia refractory to bisphosphonate therapy or denosumab
    ?Pregnant and lactating , or intending to become pregnant during the study
    ?History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    ?Malignancies other than RCC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent). Contact the Medical Monitor if there are concerns or if clarification is needed.
    ?History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener?s granulomatosis, Sjögren?s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see the protocol for a more comprehensive list of autoimmune diseases)
    Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study.
    Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
    ?History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
    ?Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or Patients with active hepatitis C
    ?Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
    ?Ausencia de tratamiento previo con fármacos sistémicos activos o experimentales, incluido el tratamiento en el contexto neoadyuvante o adyuvante. Se permite el tratamiento previo con placebo en el contexto adyuvante.
    ?Metástasis activas o no tratadas en el SNC según lo determinado al evaluar las imágenes de tomografía computarizada (TC) o resonancia magnética durante la selección y los estudios radiológicos previos
    ?Las lesiones sintomáticas susceptibles de radioterapia paliativa (p. ej., metástasis óseas o metástasis que causen pinzamiento nervioso) deben tratarse al menos 14 días antes del día 1 del ciclo 1.
    ?Derrame pleural, derrame pericárdico o ascitis no controlados que requieran procedimientos de drenaje repetidos (una vez al mes o con más frecuencia)
    ?Hipercalcemia no controlada (calcio ionizado > 1,5 mmol/l o Ca > 12 mg/dl o calcio sérico corregido mayor que el límite superior de la normalidad]) o hipercalcemia sintomática resistente al tratamiento con bisfosfonatos o denosumab
    ?Embarazo o lactancia, o intención de quedarse embarazada durante el estudio
    ?Antecedentes de reacciones alérgicas, anafilácticas u otras reacciones de hipersensibilidad graves a anticuerpos quiméricos o humanizados o a proteínas de fusión
    ?Neoplasias malignas distintas del CCR en los 5 años previos al día 1 del ciclo 1, exceptuando aquellas que tengan un riesgo insignificante de metástasis o muerte y tratadas con intención curativa (tales como carcinoma in situ de cuello uterino o cáncer de piel basocelular o espinocelular tratados adecuadamente, cáncer de próstata localizado tratado con intención curativa o carcinoma ductal in situ de mama tratado quirúrgicamente con intención curativa). Contacte con el monitor médico si tiene alguna duda o necesita alguna aclaración.
    ?Antecedentes de enfermedades autoinmunitarias, entre ellas, miastenia grave, miositis, hepatitis autoinmunitaria, lupus eritematoso sistémico, artritis reumatoide, enfermedad inflamatoria intestinal, trombosis vascular asociada a síndrome antifosfolípidos, granulomatosis de Wegener, síndrome de Sjögren, síndrome de Guillain Barré, esclerosis múltiple, vasculitis o glomerulonefritis (en el protocolo se proporciona una lista más amplia de enfermedades autoinmunitarias)
    Podrán participar en este estudio pacientes con antecedentes de hipotiroidismo autoinmunitario que estén recibiendo dosis estables de tratamiento hormonal sustitutivo.
    También podrán participar pacientes con diabetes mellitus de tipo 1 controlada que estén recibiendo dosis estables de una pauta de insulina.
    ?Antecedentes de fibrosis pulmonar idiopática, neumonía organizada (p. ej., bronquiolitis obliterante, neumonitis inducida por fármacos, neumonitis idiopática o signos de neumonitis activa en la TC de tórax de la selección
    ?Pacientes con hepatitis B activa o crónica (definida por un resultado positivo en el análisis del antígeno de superficie de la hepatitis B [HBsAg] en la selección) o pacientes con Hepatitis C activa
    ?Infecciones graves en las 4 semanas previas al día 1 del ciclo 1, entre ellas, infecciones complicadas que requieran hospitalización, bacteriemia o neumonía grave
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    Supervivencia libre de progresión (SLP) conforme a los Criterios de evaluación de la respuesta en tumores sólidos versión 1.1 (RECIST v1.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of PFS is projected to occur at 300 PFS events
    El análisis del criterio de valoración principal de la SLP se realizará cuando se hayan producido aproximadamente 300 episodios de SLP
    E.5.2Secondary end point(s)
    ?PFS based on IRC assessment of radiographic progression per RECIST v1.1
    ?OS, defined as the time from randomization to death due to any cause
    ?Time to deterioration in tiredness on the basis of Question 3 on the BFI
    ?Change from baseline in the following scores:
    Fatigue interference (Question 4 on BFI)
    Symptom interference (from MDASI)
    Diarrhea severity (from the MDASI)
    Treatment side effects subscale (from the FKSI-19)
    ?ORR, defined as the proportion of patients with an objective response (either complete response or partial response, confirmation not required) as determined by investigator per RECIST v1.1
    ?DOR, defined as the time from the first documented response to documented disease progression as determined by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first
    ?ORR and DOR based on IRC assessment per RECIST v1.1
    ?PFS, ORR, and DOR based on investigator assessment per modified RECIST criteria
    ?PFS based on investigator assessment per RECIST v1.1 and OS in patients who have detectable PD-L1 expression, which is defined as IC1/2/3
    ?SLP basada en la evaluación de la progresión radiológica por el CRI conforme a los criterios RECIST v1.1
    ?SG, definida como el tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa
    ?Tiempo transcurrido hasta el empeoramiento del cansancio basándose en la pregunta 3 del BFI
    ?Variaciones de las puntuaciones siguientes con respecto a los valores basales:
    Interferencia del cansancio (pregunta 4 del BFI)
    Interferencia de los síntomas (a partir del MDASI)
    Intensidad de la diarrea (a partir del MDASI)
    Subescala de efectos secundarios del tratamiento (a partir del FKSI 19)
    ?TRO, definida como el porcentaje de pacientes con una respuesta objetiva (respuesta completa o respuesta parcial, no es necesaria la confirmación), según determine el investigador conforme a los criterios RECIST v1.1
    ?DR, definida como el tiempo transcurrido desde la primera respuesta documentada hasta la progresión documentada de la enfermedad, según determine el investigador mediante los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes
    ?TRO y DR basándose en la evaluación del CRI conforme a los criterios RECIST v1.1
    ?SLP, TRO y DR basándose en la evaluación del investigador según los criterios RECIST modificados
    ?SLP basándose en la evaluación del investigador según los criterios RECIST v1.1 y SG en los pacientes con expresión detectable de PD L1, que se define como CI1/2/3
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of study will occur when the number of deaths required for the final analysis of OS (307 deaths) in the ITT population have been observed
    El final del estudio tendrá lugar cuando el numero de muertes requeridas para el analisis final de SG (307 muertes) en la poblacion IT se hayan observado
    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 Yes
    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 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) 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Australia
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Turkey
    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
    The end of study will occur when the number of deaths required for the final analysis of OS (307 deaths) in the ITT population have been observed.
    El final del estudio tendrá lugar cuando el numero de muertes requeridas para el analisis final de SG (307 muertes) en la poblacion IT se hayan observado
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 385
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 165
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 550
    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)
    Patients will be eligible to receive the study drug (MPDL3280A) and bevacizumab free of charge after the end of the study if all of the following conditions are met:
    ?life-threatening or severe medical condition and require continued study drug treatment for your well-being
    ?There are no appropriate alternative treatments available to you
    ?You and your doctor comply with and satisfy any legal or regulatory requirements that apply to you
    Las pacientes podrán recibir el fármaco del estudio (MPDL3280A) y bevacizumab gratis depués del final del estudio si todas las condiciones siguientes se cumplen:
    -Enfermedad grave o amenazante para la vida y necesita acceso continuado al farmaco del estudio para su bienestar
    -No hay tratamientos alternativos apropiados disponibles para usted
    -Usted y su médico cumplen y satisfacen cualquier requerimiento legal o regulatorio que les aplique.
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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