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    Summary
    EudraCT Number:2014-003206-32
    Sponsor's Protocol Code Number:GO29537
    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:2015-06-01
    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 number2014-003206-32
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN - NAB-PACLITAXEL FOR CHEMOTHERAPY NAÏVE PATIENTS WITH STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
    ESTUDIO DE FASE III, ABIERTO, MULTICENTRICO, ALEATORIZADO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MPDL3280A (ANTICUERPO ANTI-PD-L1) EN COMBINACIÓN CON CARBOPLATINO + NAB-PACLITAXEL EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO ESTADIO IV, NO EPIDERMOIDE, QUE NO HAN RECIBIDO QUIMIOTERAPIA PREVIA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical study to evaluate the efficacy and safety of MPDL3280A in combination with carboplatin + nab-paclitaxel in stage IV non-squamous non-small cell lung cancer patients.
    Estudio de Fase III para evaluar la eficacia y seguridad de MPDL3280A en combinación con carboplatino + nab-paclitaxel en pacientes con cáncer de pulmón no microcítico estadio IV, no epidermoide.
    A.4.1Sponsor's protocol code numberGO29537
    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 SponsorF. 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.3.2Product code MPDL3280A-RO5541267-F-03
    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 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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene
    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 namenab-paclitaxel
    D.3.2Product code RO024-7506
    D.3.4Pharmaceutical form Powder for 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    STAGE IV NON-SQUAMOUS NON?SMALL CELL LUNG CANCER
    Cáncer de pulmón no microcítico estadio IV, no epidermoide.
    E.1.1.1Medical condition in easily understood language
    STAGE IV NON-SQUAMOUS NON?SMALL CELL LUNG CANCER
    Cáncer de pulmón no microcítico estadio IV, no epidermoide.
    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
    ?To evaluate the efficacy of MPDL3280A+ carboplatin + nab-paclitaxel compared withcarbopatin+ nab-paclitaxel in the ITT population as measured byinvestigator?assessed PFS according to RECIST v1.1
    ?To evaluate the efficacy of MPDL3280A+ carboplatin + nab-paclitaxel compared withcarbopatin+ nab-paclitaxel in the PD-L1?selected population as measured by investigator-assessed PFS according to RECIST v1.1
    - Evaluar la eficacia de MPDL3280A + carboplatino + nab-paclitaxel en comparación con carboplatino + nab-paclitaxel en la población por intención de tratar (IT), determinada mediante la supervivencia sin progresión (SSP) evaluada por el investigador conforme a los criterios RECIST v1.1.
    - Evaluar la eficacia de MPDL3280A + carboplatino + nab-paclitaxel en comparación con carboplatino + nab-paclitaxel en la población seleccionada por el PD-L1, determinada mediante la SSP evaluada por el investigador conforme a los criterios RECIST v1.1
    E.2.2Secondary objectives of the trial
    ?To evaluate the efficacy of MPDL3280A+ carboplatin + nab-paclitaxel compared withcarbopatin+ nab-paclitaxel as measured by investigator-assessed ORR according toRECIST v1.1 for both the ITT and PD-L1?selected populations
    ?To evaluate the efficacy of MPDL3280A+ carboplatin + nab-paclitaxel compared withcarbopatin+ nab-paclitaxel as measured by OS for both the ITT and PD-L1?selectedpopulations
    ?To evaluate the efficacy of MPDL3280A+ carboplatin + nab-paclitaxel compared withcarbopatin+ nab-paclitaxel as measured by investigator-assessed duration ofresponse (DOR) according to RECIST v1.1 for both the ITT and PD-L1?selected populations
    - Evaluar la eficacia de MPDL3280A + carboplatino + nab-paclitaxel en comparación con carboplatino + nab-paclitaxel, determinada mediante la tasa de respuestas objetivas (TRO) evaluada por el investigador conforme a los criterios RECIST v1.1 en las poblaciones IT y seleccionada por el PD-L1.
    - Evaluar la eficacia de MPDL3280A + carboplatino + nab-paclitaxel en comparación con carboplatino + nab-paclitaxel, determinada mediante la supervivencia global (SG) en las poblaciones IT y seleccionada por el PD-L1.
    - Evaluar la eficacia de MPDL3280A + carboplatino + nab-paclitaxel en comparación con carboplatino + nab-paclitaxel, determinada mediante la duración de la respuesta (DR) evaluada por el investigador conforme a los criterios RECIST v1.1 en las poblaciones IT y seleccionada por el PD-L1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? ECOG performance status of 0 or 1
    ? Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
    ? No prior treatment for Stage IV non-squamous NSCLC
    Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with erlotinib, gefitinib, or another EGFR tyrosine kinase inhibitor (TKI) appropriate for the treatment of EGFR-mutant NSCLC. Patients not previously tested for mutational status and who have not been previously treated with an EGFR TKI will be required to be tested at screening.
    Patients with an ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e., crizotinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene. Patients not previously tested for ALK status and who have not previously been treated with an ALK inhibitor will be requred to be tested at screening.
    ? Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy or chemoradiotherapy cycle.
    ?Measurable disease, as defined by RECIST v1.1
    ?Known PD-L1 tumor status as determined by an IHC assay performed by a centrallaboratory on previously obtained archival tumor tissue or tissue obtained from abiopsy at screening
    - Estado funcional del ECOG de 0 o 1
    - CPNM no epidermoide, confirmado mediante histología o citología, estadio IV.
    - Ausencia de tratamiento previo para el CPNM no epidermoide estadio IV.
    Los pacientes con una mutación sensibilizadora en el gen EGFR tendrán que haber presentado progresión de la enfermedad (durante o después del
    tratamiento) o intolerancia al tratamiento con erlotinib, gefitinib u otro inhibidor de la tirosina cinasa (ITC) EGFR adecuado para tratar el CPNM con mutación de EGFR. A los pacientes en que no se haya analizado previamente el estado mutacional y que no hayan sido tratados previamente con un ITC EGFR tendrán que someterse a este análisis en la visita de selección.
    Los pacientes con un oncogén de fusión ALK tendrán que haber presentado progresión de la enfermedad (durante o después del tratamiento) o intolerancia al tratamiento con uno o varios inhibidores de ALK (por ejemplo, crizotinib) adecuados para tratar el CPNM en pacientes con un oncogén de fusión ALK. A los pacientes en que no se haya analizado previamente el estado de ALK y que no hayan sido tratados previamente con un inhibidor de ALK tendrán que someterse a este análisis en la visita de selección.
    - Los pacientes que hayan recibido quimioterapia neoadyuvante o adyuvante previa o quimiorradioterapia con intención curativa para la enfermedad no metastásica tendrán que haber presentado un intervalo sin tratamiento de al menos 6 meses con respecto a la aleatorización desde el último ciclo de quimioterapia o quimiorradioterapia.
    - Enfermedad mensurable, definida conforme a los criterios RECIST v1.1.
    - Presencia de PD-L1 en el tumor, determinada mediante un análisis de IHQ realizado en un laboratorio central en tejido tumoral de archivo obtenido
    anteriormente o tejido obtenido a partir de una biopsia practicada en la visita de selección.
    E.4Principal exclusion criteria
    ?Active or untreated CNS metastases as determined by CT or MRI evaluation duringscreening and prior radiographic assessments
    ?Spinal cord compression not definitively treated with surgery and/or radiation orpreviously diagnosed and treated spinal cord compression without evidence thatdisease has been clinically stable for > 2 weeks prior to randomization
    ?Leptomeningeal disease
    ?Uncontrolled tumor-related pain
    Patients requiring pain medication must be on a stable regimen at study entry.
    Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
    Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for locoregional therapy, if appropriate, prior to randomization.
    ?Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures (once monthly or more frequently)
    ?Malignancies other than NSCLC within 5 years prior to randomization, with theexception of those with a negligible risk of metastasis or death (e.g., expected5-year OS> 90%) treated with expected curative outcome (such as adequatelytreated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localizedprostate cancer treated surgically with curative intent, ductal carcinoma in situtreated surgically with curative intent)
    ?Known tumor PD-L1 expression status from other clinical trials (e.g., patients whosePD-L1 expression status was determined during screening for entry into a trial withanti-programmed death-1 [PD-1] or anti-PD-L1 antibodies but were not eligible areexcluded)
    ?History of severe allergic, anaphylactic, or other hypersensitivity reactionsto chimeric or humanized antibodies or fusion proteins
    ?Positive test for HIV
    - Metástasis en el SNC activas o no tratadas, determinadas mediante TC o RM durante las evaluaciones radiológicas de selección y precedentes.
    - Compresión medular no tratada de forma definitiva con cirugía o radioterapia o compresión medular ya diagnosticada y tratada sin indicios de que la enfermedad haya permanecido clínicamente estable durante > 2 semanas antes de la aleatorización.
    - Afectación leptomeníngea.
    - Dolor no controlado relacionado con el tumor.
    Los pacientes que precisen analgésicos deberán estar recibiendo un régimen estable al incorporarse al estudio.
    Las lesiones sintomáticas susceptibles de radioterapia paliativa (por ejemplo, metástasis óseas o causantes de compresión de nervios) deberán tratarse
    antes de la aleatorización. Los pacientes deberán haberse recuperado de los efectos de la radiación. No se exigirá un período de recuperación mínimo.
    En las lesiones metastásicas asintomáticas cuyo crecimiento adicional es probable que cause déficit funcionales o dolor incontrolable (por ejemplo,
    metástasis epidural no acompañada en ese momento de compresión medular) deberá contemplarse el uso de tratamiento locorregional, según proceda, antes de la aleatorización.
    - Derrame pleural, derrame pericárdico o ascitis no controlados con necesidad de procedimientos de drenaje recurrentes (una vez al mes o con más frecuencia).
    - Tumores malignos distintos del CPNM en los 5 años previos a la aleatorización, salvo aquellos con un riesgo insignificante de metástasis o muerte (por ejemplo, SG a los 5 años prevista > 90 %) tratados con previsión de curación (como carcinoma in situ de cuello uterino debidamente tratado, cáncer basocelular o espinocelular de piel, cáncer de próstata localizado tratado mediante cirugía con intención curativa, carcinoma canalicular in situ tratado mediante cirugía con intención curativa).
    - Expresión tumoral conocida de PD-L1 a partir de otros ensayos clínicos (por ejemplo, quedarán excluidos los pacientes en que se determinó la expresión de PD-L1 durante la selección para participar en un ensayo con anticuerpos anti-PD-1 o anti-PD-L1, pero que no fueron aptos finalmente).
    - Antecedentes de reacciones alérgicas, anafilácticas o de hipersensibilidad intensas frente a proteínas de fusión o anticuerpos humanizados o quiméricos.
    - Resultado positivo en una prueba del VIH.
    E.5 End points
    E.5.1Primary end point(s)
    ?PFS, defined as the time from randomization to the first occurrence of diseaseprogression as determined by the investigator using RECIST v1.1 or death from anycause, whichever occurs first
    - SSP, definida como el tiempo transcurrido entre la aleatorización y el primer episodio de progresión de la enfermedad, determinada por el investigador conforme a los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.1.1
    Por favor consultar E.5.1.1
    E.5.2Secondary end point(s)
    ?Objective response, defined as partial response (PR) or complete response (CR) asdetermined by the investigator according to RECIST v1.1
    ?OS, defined as the time from randomization to death from any cause
    ?DOR, defined as the time interval from first occurrence of a documented objectiveresponse to the time of disease progression as determined by the
    - Respuesta objetiva, definida como una respuesta parcial (RP) o completa (RC) determinada por el investigador conforme a los criterios RECIST v1.1.
    - SG, definida como el tiempo transcurrido entre la aleatorización y la muerte por cualquier causa.
    - DR, definida como el tiempo transcurrido entre el primer episodio de respuesta objetiva documentada y la fecha de progresión de la enfermedad, determinada por el investigador conforme a los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2
    Por favor,consultar E.5.2
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    Spain
    United States
    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 is when the required number of deaths have been observed
    El final del estudio tendrá lugar cuando se haya observado el número exigido de muertes.
    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 months2
    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 months4
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 215
    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)
    The Sponsor will evaluate the appropriateness of continuing to provide MPDL3280A to patients assigned to this treatment after evaluating the primary and secondary efficacy outcome measures and safety data gathered in the study.
    El promotor valorará la conveniencia de seguir proporcionando MPDL3280A a los pacientes asignados a recibir dicho tratamiento tras evaluar los criterios de valoración principales y secundarios de la eficacia y los datos de seguridad recogidos en el estudio.
    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 Decision2015-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-18
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