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    Summary
    EudraCT Number:2015-000269-30
    Sponsor's Protocol Code Number:MO29518
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-27
    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 number2015-000269-30
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICOHORT, PHASE II STUDY OF MPDL3280A IN ADVANCED SOLID TUMORS
    ESTUDIO DE FASE II, ABIERTO, MULTICOHORTE DE MPDL3280A EN TUMORES SÓLIDOS AVANZADOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, multicohort, phase II study of MPDL3280A in advanced solid tumors
    Estudio abierto, multicohorte, fase II de MPDL3280A en tumores sólidos avazanzados.
    A.3.2Name or abbreviated title of the trial where available
    Basket
    A.4.1Sponsor's protocol code numberMO29518
    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., que representa en España a 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 organisationGenentech Inc. c/o F. 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+34 91 325 73 00
    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.3.1Product nameMPDL3280A -RO5541267-F03-01
    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.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
    Patients affected by solid tumors other than hematologic malignancies, non small cell lung cancer , triple-negative breast cancer, urothelial bladder cancer, renal cell carcinoma, melanoma, and glioblastoma that are advanced and have progressed following at least one line of prior systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator.
    Pacientes afectados por tumores sólidos otros que malignidades hematológicas, cáncer de pulmón no microcítico, cáncer de mama triple negativo, cancer urotelial de vejiga, carcinoma de celulas renales, melanoma y glioblastoma que sean avanzados y hayan progresado tras al menos un linea de terapia sistémica previa o para los que no exista terapia estandard o curativa o no se considere apropiada por el investigador.
    E.1.1.1Medical condition in easily understood language
    Study for evaluation of activity of MPDL3280A in different types of tumors
    Estudio para la evaluación de la actividad de MPDL3280A en diferentes tipos de tumores.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the percentage of patients that do not experience progression during the first 18 weeks of treatment with MPDL3280A in patients affected by advanced solid tumors.
    El objetivo principal es evaluar lel porcentaje de pacientes que no experimentan progresión durnate las primeras 18 semanas de tratamiento con MPDL3280A en pacientes afectados por tumores sólidos avanzados.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the percentage of patients that do not progress during the first 24 weeks of treatment with MPDL3280A, the percentage of patients that achieve a response, the best response achieved, the duration of response and the progression free survival; these variables will be evaluated according to RECIST criteria v1.1. and according to modified RECIST criteria. Moreover OS will be evaluated as secondary endpoint.
    Los objetivos secundarios son evaluar el porcentaje de pacientes que no progresan durante las 24 primeras semanas de tratamiento con MPDL3280A, el porcentaje de pacientes que alcanzan respuesta, la mejor respuesta alcanzada, la duración de la respuesta y la supervivencia libre de progresión; estas variables se evaluarán de acuerdo a los criterios RECIST v1.1 y de acuerdo a los criterios RECIST modificados. Además se evaluará la supervivencia global como objetivo secundario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Ability to comply with protocol
    2.Male or female, 18 years of age or older
    3.Histologically- or cytologically-documented solid tumors that are advanced and have progressed following at least one line of prior systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
    4.Representative formalin-fixed paraffin-embedded tumor specimens in paraffin blocks or, in exceptional cases, 15 unstained slides, with an associated pathology report, for central testing. Detection of tumor in the provided block needs to be confirmed by the central pathology laboratory prior to study enrollment. Patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with the Sponsor
    Only tissue from core needle, punch or excisional biopsy sample collection will be accepted. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. Fine-needle aspiration, brushing, bone tissue, and lavage samples are not acceptable
    Patients who do not have tissue specimens meeting eligibility requirements must undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions
    5.Measurable disease as defined by RECIST, v1.1. (except for prostate cancer and malignant pleural mesothelioma) and disease-specific criteria for patients with prostate cancer (see Appendix 6) and malignant pleural mesothelioma (see Appendix 7)
    6.ECOG Performance Status of 0 or 1
    7.Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):
    -Absolute neutrophil count (ANC) ? 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks before Cycle 1, Day 1)
    -Lymphocyte count ? 500/µL
    -White blood cell counts > 2500/?L
    -Platelet count ? 100,000/µL (without transfusion within 2 weeks before Cycle 1, Day 1)
    -Hemoglobin ? 9.0 g/dL (patients may be transfused or receive erythropoyetic treatment to meet this criterion)
    -Serum bilirubin < 1.5 × upper limit of normal (ULN), with the following exception:
    Patients with known Gilbert disease who have serum bilirubin level ? 3 × ULN may be enrolled
    -Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ? 2.5 × ULN, with the following exceptions:
    Patients with liver involvement: AST and/or ALT ? 5 × ULN
    Patients with liver or bone metastases: alkaline phosphatase ? 5 × ULN
    -Serum creatinine ? 1.5 × ULN
    -International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ? 1.5 × ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low?molecular weight heparin or warfarin) should be on a stable dose
    8.Women who are not postmenopausal (? 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
    9.For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of MPDL3280A
    1. Capacidad para cumplir los requisitos del protocolo.
    2. Varón o mujer de 18 años o más de edad.
    3. Tumores sólidos confirmados mediante histología o citología que estén avanzados y que hayan mostrado progresión tras recibir al menos una línea de tratamiento sistémico previo o para los que no exista tratamiento de referencia o curativo o no lo considere adecuado el investigador.
    4. Muestras tumorales fijadas en formol e incluidas en parafina (FFIP) representativas en bloques de parafina (de elección) o, en casos excepcionales, 15 extensiones sin teñir, con un informe anatomopatológico acompañante, para su examen centralizado. La detección de tumor en el bloque (o extensiones) proporcionado deberá confirmarse en el laboratorio central de anatomía patológica antes de la inclusión del paciente en el estudio. Los pacientes con menos de 15 extensiones sin teñir disponibles en el momento basal (pero no menos de 10) podrán participar después de consultar al promotor.
    Solo se aceptará tejido procedente de muestras de biopsia con aguja gruesa, con sacabocados o por escisión. En el caso de las muestras de biopsia con aguja gruesa, deberá enviarse un mínimo de tres núcleos para evaluación. Las muestras de aspiración con aguja fina, cepillado, tejido óseo y lavado no serán aceptables.
    Los pacientes que no cuenten con muestras de tejido tumoral que cumplan los requisitos para participar en el estudio deberán someterse a una biopsia durante el período de selección. Entre las muestras aceptables figurarán las obtenidas mediante biopsia con aguja gruesa para recoger tejido tumoral profundo (mínimo de 3 núcleos) o mediante biopsia por escisión, incisión, con sacabocados o con pinzas para obtener tejido de lesiones cutáneas, subcutáneas o mucosas.
    5. Enfermedad mensurable, definida conforme a los criterios RECIST, v1.1 (salvo cáncer de próstata y mesotelioma pleural maligno) y conforme a criterios específicos de la enfermedad en los pacientes con cáncer de próstata (véase el apéndice 6) y mesotelioma pleural maligno (véase el apéndice 7).
    6. Estado funcional del ECOG de 0 o 1.
    7. Función hematológica y de órganos efectores adecuada, definida por los resultados analíticos siguientes obtenidos en los 14 días previos a la administración de la primera dosis del tratamiento del estudio (día 1 del ciclo 1):
    - Recuento absoluto de neutrófilos (RAN) ? 1500 células/µl (sin apoyo con factor estimulador de las colonias de granulocitos durante las 2 semanas previas al día 1 del ciclo 1).
    - Recuento de linfocitos ? 500/µl.
    - Recuento de leucocitos > 2500/µl.
    - Recuento de plaquetas ? 100.000/µl (sin transfusiones durante las 2 semanas previas al día 1 del ciclo 1).
    - Hemoglobina ? 9,0 g/dl (los pacientes podrán recibir transfusiones o tratamiento eritropoyético para cumplir este criterio).
    - Bilirrubina sérica < 1,5 veces el límite superior de la normalidad (LSN), con la siguiente excepción:
    Se podrá incluir a pacientes con síndrome de Gilbert documentado que presenten una concentración sérica de bilirrubina ? 3 veces el LSN.
    - Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) y fosfatasa alcalina ? 2,5 veces el LSN, con las siguientes excepciones:
    Pacientes con afectación hepática: AST o ALT ? 5 veces el LSN.
    Pacientes con metástasis hepáticas u óseas: fosfatasa alcalina ? 5 veces el LSN.
    - Creatinina sérica ? 1,5 veces el LSN
    - Índice internacional normalizado (INR) y tiempo de tromboplastina parcial activado (TTPa) ? 1,5 veces el LSN. Esto es aplicable únicamente a los pacientes que no reciban anticoagulación terapéutica; los pacientes que reciban anticoagulación terapéutica (como heparina de bajo peso molecular o warfarina) deberán estar recibiendo una dosis estable.
    8. Las mujeres que no sean posmenopáusicas (? 12 meses de amenorrea no inducida por tratamiento) ni hayan sido esterilizadas quirúrgicamente deben dar negativo en una prueba de embarazo en suero realizada en los 14 días previos al inicio de la administración del fármaco del estudio
    9. Las mujeres en edad fértil y los varones con parejas en edad fértil deben comprometerse a utilizar (por su parte o por la de su pareja) métodos anticonceptivos sumamente eficaces (es decir, aquellos con una tasa baja de fracasos [< 1% al año] cuando se emplean de manera constante y correcta) y a seguir utilizándolos hasta 90 días después de recibir la última dosis de MPDL3280A.
    E.4Principal exclusion criteria
    1.Hematologic malignancies, NSCLC, triple-negative breast cancer, urothelial bladder cancer, renal cell carcinoma, melanoma, and glioblastoma
    2.Malignancies other than disease under study 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
    3.Uncontrolled tumor-related pain
    4.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    5.Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
    6.Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
    7.Leptomeningeal disease
    8.Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ? 2 weeks prior to Cycle 1, Day 1
    9.Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: hormone-replacement therapy or oral contraceptives and palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day. Acute toxicities from previous therapy that have not resolved to Grade ? 1, except for alopecia
    10.Pregnant and lactating women
    11.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
    12.Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina
    13.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
    14.Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day. Patients receiving prophylactic antibiotics are eligible
    15.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
    16.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    17.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the MPDL3280A formulation
    18.History of autoimmune disease. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
    Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
    19.Prior allogeneic bone marrow transplantation or prior solid organ transplantation
    20.History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted
    21.Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
    22.Positive test for HIV
    23.Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
    24.Active tuberculosis
    25.Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
    26.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.
    27.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti?PD1, or anti?PDL1 therapeutic antibodies. Patients who have received prior treatment with anti?CTLA-4 may be enrolled, provided at least 5 half-lives have elapsed from the last dose of anti-CTLA-4 to the first dose of MPDL3280A and there was no history of severe immune-mediated adverse effects from anti?CTLA-4
    28.Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug prior to Cycle 1, Day 1
    29.Treatment with an investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer)
    30.Known tumor PD-L1 expression status from other clinical trials
    31.Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial
    1-Neoplasias hematológicas malignas,CPNM,cáncer de mama triple negativo,cáncer urotelial de vejiga,carcinoma renal,melanoma y glioblastoma.2-Neoplasias malignas distintas de enfermedad en estudio en los 5 años previos al D1C1,salvo aquellas con riesgo insignificante de metástasis o muerte tratadas con resultado curativo previsto.3-Dolor relacionado con tumor,no controlado.4-Derrame pleural,derrame pericárdico o ascitis no controlados que requieran procedimientos de drenaje repetidos.5-Hipercalcemia no controlada o sintomática que requiera administración continuada de bifosfonatos o denosumab.6-Metástasis en SNC activas o no tratadas,evidenciadas en evaluación con TC o RM durante selección y en evaluaciones radiológicas previas.7-Afectación leptomeníngea.8-Compresión medular no tratada definitivamente mediante cirugía o radioterapia o diagnosticada y tratada previamente,sin datos de estabilización clínica de la enfermedad durante?2semanas previas al D1C1.9-Cualquier tratamiento antineoplásico aprobado,incluidas quimioterapia,hormonoterapia,radioterapia,en las 3 semanas previas al inicio de administración de tratamiento de estudio;se permitirá:tratamiento hormonal sustitutivo o anticonceptivos orales y radioterapia paliativa de metástasis ósea>2semanas antes del D1C1.Toxicidad aguda del tratamiento previo no resuelta hasta grado?1,salvo alopecia.10-Mujeres embarazadas o en período de lactancia.11-Datos de enfermedades concomitantes importantes no controladas que podrían afectar a cumplimiento del protocolo o interpretación de los resultados,como hepatopatías importantes.12-Enfermedades cardiovasculares importantes,como cardiopatías en clase II o superior de la NYHA,infarto de miocardio en los 3 meses previos al D1C1,arritmias inestables o angina de pecho inestable.13-Infecciones graves en las 4 semanas previas al D1C1,entre ellas,infecciones complicadas que requieran hospitalización,bacteriemia o neumonía grave.14-Administración de antibióticos vía oral o IV en las 2 semanas previas al D1C1.Pacientes que estén recibiendo antibióticos con fines profilácticos podrán participar.15-Intervención de cirugía mayor en los 28 días previos al D1C1 o previsión de necesidad de intervención de este tipo durante estudio.16-Antecedentes de reacciones alérgicas,anafilácticas u otras reacciones de hipersensibilidad graves a anticuerpos quiméricos o humanizados o a proteínas de fusión.17-Hipersensibilidad o alergia documentada a biofármacos elaborados en células de ovario de hámster chino o a cualquiera de los componentes de formulación de MPDL3280A.18-Antecedentes de enfermedades autoinmunitarias.Pacientes con antecedentes de hipotiroidismo autoinmunitario que estén recibiendo dosis estables de tratamiento hormonal sustitutivo permitidos.Pacientes con diabetes mellitus de tipo 1 controlada que estén recibiendo dosis estables de insulina permitidos.19-Alotrasplante de médula ósea o trasplante de órgano sólido previo.20-Antecedentes de fibrosis pulmonar idiopática,neumonitis por fármacos,neumonía organizada o datos de neumonitis activa en TC de tórax en selección. Permitidos antecedentes de neumonitis por radiación en campo irradiado.21-Cualquier otra enfermedad,disfunción metabólica,hallazgo en exploración física o resultado analítico que haga sospechar de forma razonable enfermedad o proceso que contraindique uso de fármaco experimental o que pueda afectar a interpretación de los resultados o que suponga alto riesgo de sufrir complicaciones del tratamiento para los pacientes.22-Resultado positivo prueba de VIH.23-Pacientes con hepatitis B activa(definida por resultado positivo en análisis de antígeno de superficie de virus de hepatitis B[HBsAg] realizado en selección)o hepatitis C.24-Tuberculosis activa.25-Signos o síntomas de infección en las 2 semanas previas a D1C1.26-Administración de vacuna de microorganismos vivos atenuados en las 4 semanas previas al D1C1 o previsión de necesidad de vacuna de ese tipo durante estudio.27-Tratamiento previo con agonistas de CD137 o terapias para bloquear puntos de control inmunológicos,con anticuerpos terapéuticos antiPD1 o antiPDL1.Pacientes que hayan recibido tratamiento previo con anti CTLA 4 permitidos,siempre que hayan transcurrido al menos 5 semividas entre última dosis del antiCTLA4 y primera dosis de MPDL3280A y no existan antecedentes de efectos adversos inmunitarios intensos del anti CTLA 4.28-Tratamiento con inmunoestimuladores sistémicos en las 4 semanas,o en el período equivalente a 5 semividas del fármaco previas al D1C1.29-Tratamiento con un fármaco en investigación en las 4 semanas previas al D1C1(o en el período equivalente a 5 semividas del producto en investigación,lo que suponga más tiempo).30-Estado conocido de expresión tumoral de PDL1 a partir de otros ensayos clínicos.31-Tratamiento con corticosteroides u otros inmunodepresores sistémicos en las 2 semanas previas al D1C1 o previsión de la necesidad de tratamiento con inmunodepresores sistémicos durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate non-progression rate (NPR) at 18 weeks in patients with advanced solid tumors treated with MPDL3280A, defined as the percentage of patients with complete response (CR) partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1) (except for prostate cancer and malignant pleural mesothelioma) and disease-specific criteria for patients with prostate cancer and malignant pleural mesothelioma
    Evaluar la tasa sin progresión (TSP) a las 18 semanas, definida como el porcentaje de pacientes con RC, RP o EE al cabo de 18 semanas, según lo determinado por el investigador conforme a los criterios RECIST, v1.1 (salvo en caso de cáncer de próstata y mesotelioma pleural maligno) y conforme a criterios específicos de la enfermedad en los pacientes con cáncer de próstata y mesotelioma pleural maligno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 weeks
    18 semanas.
    E.5.2Secondary end point(s)
    To evaluate NPR at 24 weeks, overall response rate (ORR), best overall response (BOR), clinical benefit rate (CBR), duration of response (DOR), time to tumor progression (TTP) and progression-free survival (PFS), as assessed by the Investigator using RECIST, v1.1 (except for prostate cancer and malignant pleural mesothelioma) and disease-specific criteria for patients with prostate cancer and malignant pleural mesothelioma
    To evaluate NPR at 18 and 24 weeks, ORR, BOR, CBR, DOR, TTP and PFS, as assessed by the Investigator using modified RECIST
    To evaluate overall survival (OS)
    Evaluar la tasa sin progresión (TSP) a las 24 semanas, tasa de respuesta global (TRG), mejor respuesta global (MRG), tasa de beneficio clínico (TECB), duración de la respuesta objetiva (DR), tiempo hasta la progresión (THP) y supervivencia sin progresión (SSP), según lo determinado por el investigador conforme a los criterios RECIST, v1.1 (salvo en caso de cáncer de próstata y mesotelioma pleural maligno) y conforme a criterios específicos de la enfermedad en los pacientes con cáncer de próstata y mesotelioma pleural maligno.
    Evaluar la TSP a las 18 y 24 semanas, TRG, MRG, TECB, SSP y THP también serán determinados por el investigador conforme a los criterios RECIST modificados.
    Evaluar la supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    NPR at 24 weeks according to RECIST v1.1
    NPR at 18 and 24 weeks according to modified RECIST
    TSP a las 24 semanas de acuerdo a RECIST v1.1
    TSP a las 18 y 24 semanas de acuerdo a los criterios RECIST modificados.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 EEA32
    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
    Brazil
    Canada
    China
    Denmark
    Finland
    France
    Germany
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 for each cohort will occur when all patients have been followed for survival for a minimum of 24 months after the last patient has been enrolled or until all patients have died, withdrawn consent or are lost to follow up, whichever occurs first.
    El final del estudio en cada cohorte tendrá lugar cuando todos los pacientes hayan sido objeto de seguimiento en cuanto a supervivencia durante un mínimo de 24 meses después de que el último paciente haya sido incluido o hasta que todos los pacientes hayan fallecido, hayan retirado su consentimiento o se hayan perdido para el seguimiento, lo que ocurra antes.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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)
    The Sponsor will offer post-trial access to the study drug (MPDL3280A) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product. The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following Web site:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    El promotor ofrecerá acceso gratuito al fármaco del estudio (MPDL3280A) después del estudio a los pacientes que reúnan los requisitos de conformidad con la política internacional de Roche sobre el acceso continuo a productos en investigación. La política internacional de Roche sobre el acceso continuo a productos en investigación se puede consultar en el sitio web siguiente:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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