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    Summary
    EudraCT Number:2015-003694-15
    Sponsor's Protocol Code Number:3475-189
    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:2015-12-10
    Trial 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 number2015-003694-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).
    Estudio de fase III, aleatorizado y doble ciego de quimioterapia con platino + pemetrexed con o sin pembrolizumab (MK 3475) en sujetos con cáncer de pulmón no microcítico, no epidermoide, metastásico en primera línea de tratamiento (KEYNOTE 189)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III study of Pemetrexed+Platinum with or without Pembrolizumab in first line (1L) metastatic non-squamous NSCLC.
    Estudio de fase III de pemetrexed+platino con o sin pembrolizumab en CPNM no epidermoide metastásico como tratamiento en primera línea (1L)
    A.4.1Sponsor's protocol code number3475-189
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02578680
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme, 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 namePembrolizumab
    D.3.2Product code MK-3475 (SCH 900475)
    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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCisplatin
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 Cisplatin Teva
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCisplatin
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 4
    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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCarboplatin
    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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 5
    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 Carboplatin Actavis
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namecarboplatin
    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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 6
    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 ALIMTA
    D.2.1.1.2Name of the Marketing Authorisation holderLilly USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePemetrexed
    D.3.4Pharmaceutical form Powder for injection
    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 INNPEMETREXED
    D.3.9.1CAS number 137281-23-3
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 7
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePemetrexed
    D.3.4Pharmaceutical form Powder for injection
    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 INNPEMETREXED
    D.3.9.1CAS number 137281-23-3
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 8
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePemetrexed
    D.3.4Pharmaceutical form Powder for injection
    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 INNPEMETREXED
    D.3.9.1CAS number 137281-23-3
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-squamous non-small cell lung cancer
    Cáncer de pulmón no microcítico, no epidermoide
    E.1.1.1Medical condition in easily understood language
    lung cancer
    Cáncer de pulmón
    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
    Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central imaging.
    Comparar la supervivencia sin progresión (SSP) conforme a los criterios RECIST 1.1 según la evaluación del laboratorio central de imagen sometido a enmascaramiento.
    E.2.2Secondary objectives of the trial
    Overall response rate (ORR) and response duration (DOR) per RECIST 1.1 by central imaging vendor review; Overall Survival (OS); PFS per RECIST 1.1 in subjects with PD-L1 Tumor Proportion Score > or = 1% as assessed by blinded central imaging vendor; PFS per investigator-assessed immune-related RECIST response criteria; Safety and tolerability profile of pembrolizumab combined with platinum-pemetrexed chemotherapy in subjects with 1L mestatatic non-squamous NSCLC.
    - Tasa de respuesta global (TRG) y duración de la respuesta (DR) conforme a los criterios RECIST 1.1 según la revisión del laboratorio central de imagen
    - Supervivencia global (SG)
    - En sujetos con PD L1 con PPT > o = 1 %, la SSP conforme a los criterios RECIST 1.1 según la evaluación del laboratorio central de imagen sometido a enmascaramiento.
    - La supervivencia sin progresión (SSP) según la respuesta evaluada por el investigador conforme a los criterios RECISTri.
    - Perfil de seguridad y tolerabilidad de pembrolizumab combinado con quimioterapia a base de platino y pemetrexed en sujetos con CPNM no epidermoide metastásico como 1L.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck realizará investigaciones biomédicas futuras con las muestras obtenidas para tal finalidad durante este ensayo clínico. Estas investigaciones tendrán por objeto el análisis de biomarcadores con el fin de abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del ensayo principal) y solo se llevarán a cabo en muestras de los pacientes que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para investigaciones biomédicas futuras es estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades y sus tratamientos. El objetivo último es utilizar tal información para desarrollar fármacos más seguros y eficaces o para garantizar que los sujetos reciban la dosis correcta del fármaco en el momento preciso.
    E.3Principal inclusion criteria
    ?Have a histologically-confirmed or cytologically-confirmed diagnosis of stage IV (M1a or M1b AJCC 7th edition) non-squamous NSCLC.
    ?Confirmation that EGFR or ALK-directed therapy is not indicated.
    ?Have measurable disease based on RECIST 1.1 as determined by the local site
    investigator/radiology assessment. Target lesions situated in a previously irradiated
    area are considered measurable if progression has been demonstrated in such lesions.
    ?Have not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant therapy are eligible if the adjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
    ?Have provided tumor tissue from locations not radiated prior to biopsy; formalin-fixed specimens after the subject has been diagnosed with metastatic disease will be preferred for determination of PD-L1 status prior to randomization. Biopsies obtained prior to receipt of adjuvant chemotherapy will be permitted if recent biopsy is not feasible.
    ?Life expectancy of at least 3 months.
    ?ECOG performance status of 0 or 1
    ?Have adequate organ function as indicated by in the protocol specified laboratory values
    ?If female of childbearing potential (Section 5.7.2), have a negative urine or serum
    pregnancy test within 72 hours prior to receiving the first dose of study medication.
    If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
    will be required.
    ?If female of childbearing potential (Section 5.7.2), be willing to use an adequate
    method of contraception as outlined in Section 5.7.2-Contraception, for the course of
    the study through 120 days after the last dose of study medication or through 180
    days after last dose of chemotherapeutic agents as specified in the protocol.
    Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for
    the subject.
    ?If male subject with a female partner(s) of child-bearing potential, must agree to use
    an adequate method of contraception as outlined in Section 5.7.2-Contraception,
    starting with the first dose of study therapy through 120 days after the last dose of
    study therapy or through 180 days after last dose of chemotherapeutic agents as
    specified in the protocol. Males with pregnant partners must agree to use a condom;
    no additional method of contraception is required for the pregnant partner.
    Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for
    the subject.
    ?Subject has voluntarily agreed to participate by giving written informed
    consent/assent for the trial. The subject may also provide consent/assent for Future
    Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    - Tener un diagnóstico con confirmación histológica o citológica de CPNM no epidermoide en estadio IV (M1a o M1b AJCC 7ª edición).
    - Tener la confirmación de que en su caso no está indicado el tratamiento dirigido al EGFR o a ALK .
    - Tener enfermedad mensurable conforme a los criterios RECIST 1.1 según la evaluación radiológica/del investigador del centro local. Las lesiones tumorales diana ubicadas en una zona previamente irradiada se considerarán mensurables siempre que se haya demostrado progresión en dichas lesiones.
    - No haber recibido previamente tratamiento sistémico para el CPNM avanzado o metastásico. Los sujetos que hayan recibido tratamiento adyuvante podrán participar en el estudio si dicho tratamiento se completó al menos 12 meses antes del desarrollo de la enfermedad metastásica.
    - Haber proporcionado tejido tumoral procedente de focos no irradiados antes de la biopsia; a fin de determinar el estado relativo a PD L1 antes de la aleatorización se preferirá las muestras fijadas en formol después de que se haya diagnosticado al sujeto de afectación metastásica. Se admitirán biopsias obtenidas antes de que el paciente reciba la quimioterapia adyuvante si no es factible una biopsia reciente.
    - Tener una esperanza de vida de al menos 3 meses.
    - Estado funcional del ECOG de 0 o 1.
    - Tener una función orgánica adecuada, conforme a los valores analíticos indicados en el protocolo.
    - Las mujeres en edad fértil (sección 5.7.2) deberán tener una prueba de embarazo en orina o suero negativa en las 72 horas previas a la administración de la primera dosis de medicación del estudio. Cuando el resultado de la prueba en orina sea positivo o no pueda confirmarse que es negativo, será necesario hacer una prueba de embarazo en suero.
    - Las pacientes en edad fértil (sección 5.7.2) deben estar dispuestas a utilizar un método anticonceptivo adecuado como se indica en la sección 5.7.2 Anticoncepción, durante el estudio y hasta 120 días después de la última dosis del medicamento del estudio o hasta 180 días después de la última dosis de quimioterápicos indicados en el protocolo.
    Nota: la abstinencia es aceptable si es el estilo de vida habitual y preferido del sujeto.
    - Si el sujeto es varón con pareja mujer en edad fértil debe acceder a utilizar un método anticonceptivo adecuado como se indica en la sección 5.7.2 Anticoncepción, desde la primera dosis del tratamiento del estudio y hasta 120 días después de la última dosis del medicamento del estudio o hasta 180 días después de la última dosis de quimioterápicos indicados en el protocolo. Los varones con parejas embarazadas deberán comprometerse a utilizar preservativo; no se exigirá ningún otro método anticonceptivo en la pareja embarazada.
    Nota: la abstinencia es aceptable si es el estilo de vida habitual y preferido del sujeto.
    - El sujeto ha accedido voluntariamente a participar dando su consentimiento o asentimiento informado por escrito. También podrán otorgar su consentimiento o asentimiento para las investigaciones biomédicas futuras. No obstante, podrá participar en el ensayo principal sin necesidad de hacerlo en las investigaciones biomédicas futuras.
    E.4Principal exclusion criteria
    ?Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible.
    ?Before the first dose of trial treatment:
    a)Has received prior systems cytotoxic chemotherapy for metastatic disease
    b)Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab)
    c)Had major surgery <3 weeks prior to first dose
    ?Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment
    ?Completed palliative radiotherapy within 7 days of the first dose of trial treatment
    ?Expected to require any other form of antineoplastic therapy while on study
    ?Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
    ?Clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis
    ?Known history of prior malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of the therapy.
    Note: The time requirement for no evidence of disease for 5 years does not apply to the NSCLC tumor for which a subject is enrolled in the study. The time requirement also does not apply to subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
    ?Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Patients with asymptomatic brain metastases may participate but will require regular imaging of the brain as a site of disease.
    ?Previously had a severe hypersensitivity reaction to treatment with another mAb.
    ?Has a known sensitivity to any component of cisplatin, carboplatin or pemetrexed
    ?Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    ?Is on chronic systemic steroids. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
    ?Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ? 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
    ?Is unable or unwilling to take folic acid or vitamin B12 supplementation.
    ?Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Has participated in any other MK-3475 trial and has been treated with MK-3475.
    Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, GITR
    ?Has an active infection requiring therapy
    ?Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    ?Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
    ?Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
    ?Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
    - Tiene CPNM de histología predominantemente epidermoide. Los tumores mixtos se clasificarán por el tipo de célula predominante; si hay elementos microcíticos presentes, el sujeto no será candidato a participar
    - Antes de la primera dosis del tratamiento del ensayo:
    a)Ha recibido quimioterapia citotóxica sistémica previa para la metástasis
    b)Ha recibido tratamiento biológico antineoplásico (p. ej., erlotinib, crizotinib, cetuximab)
    c)Se sometió a cirugía mayor (< 3 semanas antes de la primera dosis)
    - Recibió radioterapia en el pulmón de > 30 Gy en los 6 meses previos a la primera dosis del tratamiento del ensayo
    - Finalizó la radioterapia paliativa en los 7 días previos a la primera dosis del tratamiento del ensayo
    - Está previsto que necesite cualquier otra modalidad de tratamiento antineoplásico local o sistémico durante el estudio
    - Ha recibido una vacuna de virus vivos en los 30 días previos al comienzo previsto del tratamiento. Se permiten las vacunas contra la gripe estacional que no contengan virus vivos
    - Tiene diverticulitis, absceso intra-abdominal, obstrucción GI o carcinomatosis abdominal clínicamente activos
    - Tiene antecedentes conocidos de neoplasias malignas previas, salvo si el sujeto se ha sometido a un tratamiento potencialmente curativo y no ha habido indicios de recidiva de la enfermedad durante 5 años desde el comienzo del tratamiento
    Nota: el requisito temporal de cinco años de ausencia de datos de enfermedad no se aplica al CPNM que motive la inclusión del sujeto en el ensayo. Dicho requisito temporal tampoco se aplica a los sujetos que se hayan sometido a una resección definitiva satisfactoria de un carcinoma basocelular de piel, cáncer de vejiga superficial, carcinoma espinocelular de piel, cáncer cervicouterino localizado u otros cánceres localizados
    - Presentar metástasis activas en el sistema nervioso central (SNC) y/o meningitis carcinomatosa. Los sujetos con metástasis cerebrales tratadas previamente podrán participar si llevan al menos 2 semanas clínicamente estables y no muestran indicios de metástasis nuevas o que hayan aumentado de tamaño y además no toman esteroides desde 3 días antes de la administración del medicamento del estudio. Las metástasis cerebrales estables conforme a esta definición deberán determinarse antes de la primera dosis del medicamento del estudio. Los sujetos con metástasis cerebrales asintomáticas pueden participar, pero deberán someterse a estudios de imagen periódicos del cerebro como foco de enfermedad
    - Ha tenido previamente reacciones grave de hipersensibilidad al tratamiento con otro AcM
    - Tiene una alergia conocida a algún componente del cisplatino, carboplatino o pemetrexed
    - Tiene una enfermedad autoinmunitaria activa que ha necesitado tratamiento sistémico en los dos años precedentes (es decir, fármacos modificadores de la enfermedad, corticosteroides o inmunosupresores). El tratamiento de sustitución (p. ej., tiroxina, insulina, o terapia de sustitución de corticosteroides en dosis fisiológicas para una insuficiencia suprarrenal o hipofisaria, etc.) no se considera una forma de tratamiento sistémico
    - Recibe tratamiento crónico con esteroides sistémicos. No se excluirá del estudio a los sujetos con asma que necesiten un uso intermitente de broncodilatadores, esteroides inhalados o inyecciones locales de esteroides
    - No puede interrumpir el tratamiento con ácido acetilsalicílico u otros antiinflamatorios no esteroideos (AINEs) excepto una dosis de aspirina ? 1,3 g al día, durante un periodo de 5 días (8 días para agentes de acción prolongada, como piroxicam)
    - No puede o no está dispuesto a tomar un suplemento de ácido fólico o vitamina B12
    - Ha recibido tratamiento previo con algún otro fármaco anti PD 1 o dirigido a PD L1 o PD L2 o con un anticuerpo dirigido a otros mecanismos o receptores inmunoreguladores. Ha participado en algún otro ensayo de MK 3475 y ha sido tratado con MK 3475. Los ejemplos de anticuerpos de este tipo incluyen, entre otros, anticuerpos contra IDO, PD L1, IL 2R, GITR
    - Presenta una infección activa que requiere tratamiento
    - Tiene antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) (anticuerpos VIH 1/2)
    - Tiene hepatitis B o C conocidas. La hepatitis B activa se define como un resultado positivo para HBsAg conocido. La hepatitis C activa se define por un resultado positivo demostrado de anticuerpos contra el VHC y por un resultado cuantitativo de ARN del VHC por encima del límite inferior de detección del análisis
    - Presenta ascitis o derrame pleural sintomáticos. Podrán participar los sujetos que se encuentren clínicamente estables tras recibir tratamiento por estas enfermedades (como toracocentesis o paracentesis terapéuticas)
    - Tiene una enfermedad pulmonar intersticial o antecedentes de neumonitis que requirió el uso de glucocorticoides por vía oral o intravenosa como parte del tratamiento. La diseminación linfangítica del CPNM no es excluyente
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central imaging.
    Supervivencia sin progresión (SSP) conforme a los criterios RECIST 1.1, según lo determinado por el laboratorio central de imagen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks (C3D1), 12 weeks (C5D1), 21 weeks (C8D1), 30 weeks (C11D1), 39 weeks (C14D1), 48 weeks (C17D1), 60 weeks (C21D1), 72 weeks (C25D1), 84 weeks (C29D1), 96 weeks (C33D1), End of Treatment, Safety Follow-up.
    6 semanas (C3D1), 12 semanas (C5D1), 21 semanas (C8D1), 30 semanas (C11D1), 39 semanas (C14D1), 48 semanas (C17D1), 60 semanas (C21D1), 72 semanas (C25D1), 84 semanas (C29D1), 96 semanas (C33D1), Fin de Tratamiento, Seguimiento de Seguridad.
    E.5.2Secondary end point(s)
    ?Overall response rate (ORR) and response duration (DOR) per RECIST 1.1 by central
    imaging vendor review
    ?Overall Survival (OS)
    ?In subjects with PD-L1 TPS > or = 1%, PFS per RECIST 1.1 as assessed by blinded central
    imaging vendor
    ?Progression Free Survival (PFS) per investigator assessed irRECIST response criteria
    ?Safety and tolerability profile of pembrolizumab combined with platinum-pemetrexed
    chemotherapy in subjects with 1L metastatic non-squamous NSCLC.
    - Tasa de respuesta global (TRG) y duración de la respuesta (DR) conforme a los criterios RECIST 1.1 según la revisión del laboratorio central de imagen
    - Supervivencia global (SG)
    - En sujetos con PD L1 con PPT > o = 1 %, la SSP conforme a los criterios RECIST 1.1 según la evaluación del laboratorio central de imagen sometido a enmascaramiento.
    - La supervivencia sin progresión (SSP) según la respuesta evaluada por el investigador conforme a los criterios RECISTri.
    - Perfil de seguridad y tolerabilidad de pembrolizumab combinado con quimioterapia a base de platino y pemetrexed en sujetos con CPNM no epidermoide metastásico como 1L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks (C3D1), 12 weeks (C5D1), 21 weeks (C8D1), 30 weeks (C11D1), 39 weeks (C14D1), 48 weeks (C17D1), 60 weeks (C21D1), 72 weeks (C25D1), 84 weeks (C29D1), 96 weeks (C33D1), End of Treatment, Safety Follow-up.
    6 semanas (C3D1), 12 semanas (C5D1), 21 semanas (C8D1), 30 semanas (C11D1), 39 semanas (C14D1), 48 semanas (C17D1), 60 semanas (C21D1), 72 semanas (C25D1), 84 semanas (C29D1), 96 semanas (C33D1), Fin de Tratamiento, Seguimiento de Seguridad.
    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 No
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Austria
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Japan
    Netherlands
    Spain
    United Kingdom
    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 overall trial ends when the last subject completes the last study-related phone call or visit, discontinues from the trial or is lost to follow-up (i.e., the subject is unable to be contacted by the investigator).
    El fin del estudio ocurrirá cuando el último paciente complete la última de las llamadas telefónicas o visita relacionada con el estudio, discontinúe el ensayo o se produzca una pérdida de seguimiento (por ejemplo, el sujeto es incapaz de ser contactado por el investigador).
    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 months1
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 302
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 268
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 570
    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)
    Subjects will be followed for up to 2 years. If the subject experienced a CR, PR, or SD during the Treatment Phase on pembrolizumab, and then experiences PD at any time during that two year follow-up period, he/she will be eligible to receive up to 12 months of therapy with pembrolizumab monotherapy in the Second Course Phase. After the Second Course Phase, subjects should be followed for up to two years, with no option for retreatment with pembrolizumab on study.
    Los sujetos serán seguidos durante un máximo de 2 años. Si el sujeto experimenta una RC, RP o PE durante la fase de tratamiento con pembrolizumab y después presenta PE en algún momento del seguimiento de 2 años, será candidato a recibir un máximo de 12 meses de tratamiento con pembrolizumab en la segunda fase de tratamiento. Después de la segunda fase de tratamiento, los sujetos deberían ser seguidos un máximo de dos años, sin opción de repetir el tratamiento con pembrolizumab durante 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 Decision2016-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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