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    Summary
    EudraCT Number:2018-001517-32
    Sponsor's Protocol Code Number:MS200647-0037
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-25
    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 number2018-001517-32
    A.3Full title of the trial
    A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 versus
    Pembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer
    Estudio en fase II, multicéntrico, aleatorizado, abierto y controlado de M7824 frente a pembrolizumab como tratamiento de primera línea en pacientes con cáncer de pulmón no microcítico avanzado con expresión de PD-L1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    1L NSCLC Phase II RCT M7824 vs Pembrolizumab
    ECA en fase II de M7824 frente a pembrolizumab en el tratamiento de 1L del CPNM
    A.4.1Sponsor's protocol code numberMS200647-0037
    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 KGaA
    B.1.3.4CountryGermany
    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 KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151 72 5200
    B.5.5Fax number+496151 72 2000
    B.5.6E-mailservice@merckgroup.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 M7824
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeMSB0011359C
    D.3.9.3Other descriptive nameM7824
    D.3.9.4EV Substance CodeSUB179957
    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 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 KEYTRUDA 25 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp &Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNPEMBROLIZUMAB
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive name-
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name KEYTRUDA 50 mg Powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp &Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number -
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive name-
    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 number50
    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
    Non-small Cell Lung Cancer
    Cáncer de pulmón no microcítico
    E.1.1.1Medical condition in easily understood language
    Non-small Cell Lung Cancer
    Cáncer de pulmón no microcítico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 whether M7824 improves ORR compared with pembrolizumab in
    first-line participants with advanced NSCLC with high PD-L1 tumor expression

    To evaluate whether M7824 improves PFS compared with pembrolizumab in
    first-line participants with advanced NSCLC with high PD-L1 tumor expression
    Evaluar si M7824 mejora la TRO en comparación con pembrolizumab en pacientes en primera línea con CPNM avanzado con una elevada expresión tumoral de PD-L1.

    Evaluar si M7824 mejora la SSP en comparación con pembrolizumab en pacientes en primera línea con CPNM avanzado con una elevada expresión tumoral de PD-L1
    E.2.2Secondary objectives of the trial
    Safety
    -To evaluate the safety and tolerability of M7824 compared with pembrolizumab

    Efficacy
    -To evaluate whether M7824 improves overall survival time compared with pembrolizumab
    - ORR assessed by Investigators
    - PFS assessed by Investigators
    - DOR

    PK
    -To characterize PK profile of M7824

    Immunogenicity
    -To characterize the immunogenicity
    of M7824
    Seguridad
    -Evaluar la seguridad y tolerabilidad de M7824 en comparación con pembrolizumab

    Eficacia
    -Evaluar si M7824 mejora el tiempo de supervivencia general en comparación con pembrolizumab
    -TRO evaluada por los investigadores
    -SSP evaluada por los investigadores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. >= 18 years of age inclusive, at the time of signing the informed consent

    2. histologically confirmed diagnosis of advanced NSCLC and:
    a. Have not received prior systemic therapy treatment for their advanced/Stage IV
    NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy,
    and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy
    was completed at least 6 months prior to the diagnosis of metastatic disease.
    Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant
    chemotherapy therapy to Grade ≤ 1. For radiation toxicity or prior major surgeries,
    participants should have recovered from side effects and/or complications.
    b. Have measurable disease based on RECIST 1.1
    c. Have a life expectancy of at least 3 months
    d. Availability of either tumor archival material (< 6 months old) or fresh biopsies
    collected within 28 days (excluding bone biopsies) before the first dose is mandatory
    to determine PD-L1 expression level prior to enrollment
    e. PD-L1 high status is required

    (other protocol defined criteria could apply)
    1.>= 18 años al tiempo de firma del consentimiento informado
    2. Diagnóstico confirmado histológicamente de CPNM avanzado y:
    a. No han recibido tratamiento de terapia sistémica previo para su etapa avanzada / IV
    CPNM. Finalización del tratamiento con quimioterapia citotóxica, terapia biológica,
    y / o la radiación como parte de la terapia neoadyuvante / adyuvante está permitida siempre que la terapia se completó al menos 6 meses antes del diagnóstico de enfermedad metastásica.
    Confirmación de la resolución de los efectos tóxicos de neoadyuvante previo / adyuvante
    terapia de quimioterapia de Grado ≤ 1. Para toxicidad por radiación o cirugías mayores previas,
    los participantes deberían haberse recuperado de los efectos secundarios y / o complicaciones.
    segundo.
    b.Tener una enfermedad mensurable basada en RECIST 1.1
    c. Tener una esperanza de vida de al menos 3 meses
    d. Disponibilidad de material de archivo tumoral (<6 meses de edad) o biopsias frescas
    recogidos dentro de los 28 días (excluidas las biopsias óseas) antes de que la primera dosis sea obligatoria para determinar el nivel de expresión de PD-L1 antes de la inscripción
    mi.
    e. El estado alto de PD-L1 es requerido

    (se pueden aplicar otros criterios definidos por el protocolo)
    E.4Principal exclusion criteria
    1. The participant’s tumor harbors an EGFR sensitizing (activating) mutation, ALK
    translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is
    locally approved
    2. Has received major surgery within 4 weeks prior to the first dose of study intervention;
    received thoracic RT of > 30 Gy within 6 months prior to the first dose of study
    7. Known severe hypersensitivity reactions to mAB
    8. Receipt of any organ transplantation
    9. Has interstitial lung disease (ILD) OR has had a history of pneumonitis that has required
    oral or IV steroids
    10. Significant acute or chronic infections
    11. Has a history or current evidence of any condition, therapy, or laboratory abnormality
    that might confound the results of the study, interfere with participation for the full
    duration of the study, or is not in the best interest of the participant, in the opinion of the
    treating Investigator
    12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
    anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
    ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or
    checkpoint pathways)
    intervention.
    13. Previous malignant disease
    14. Has active CNS metastases causing clinical symptoms or metastases that require
    therapeutic intervention and/or carcinomatosis meningitis
    15. Active autoimmune disease that has required systemic treatment in past 1 year OR is
    receiving systemic steroid therapy < 3 days prior to the first dose of study intervention or
    receiving any other form of immunosuppressive medication.
    16. Is expected to require any other form of systemic or localized antineoplastic therapy
    while on study (including maintenance therapy with another agent for NSCLC, RT,
    and/or surgical resection)

    (other protocol defined criteria could apply)
    1. El tumor del participante alberga una mutación sensibilizante (activadora) de EGFR, ALK
    translocación, reordenamiento ROS1 o mutación BRAF V600E, si la terapia dirigida es
    Aprobado localmente
    2. Ha recibido una cirugía mayor dentro de las 4 semanas anteriores a la primera dosis de la intervención del estudio;recibió RT torácica de> 30 Gy en los 6 meses previos a la primera dosis del estudio
    7. Reacciones de hipersensibilidad graves conocidas a mAB
    8. Recibo de cualquier trasplante de órgano
    9. Tiene enfermedad pulmonar intersticial (EPI) O ha tenido un historial de neumonitis que ha requerido esteroides orales o IV
    10. Agudo agudo significativo
    E.5 End points
    E.5.1Primary end point(s)
    1) BOR according to RECIST 1.1
    assessed by IRC

    2) PFS according to RECIST 1.1
    assessed by IRC
    1) MRG según RECIST 1.1 evaluada por el CRI
    2)SSP según RECIST 1.1 evaluada por el CRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Time from randomization to planned final assessment for unconfirmed BOR, expected at
    26 months.

    2) Time from randomization to planned final assessment for PFS after 192 events expected
    at 37 months.
    1) Tiempo desde la aleatorización hasta la evaluación final planificada para la MRG no confirmada, prevista a los 26.

    2) Tiempo desde la aleatorización hasta la evaluación final planificada para la SSP después de 192 acontecimientos, prevista a los 37 meses.
    E.5.2Secondary end point(s)
    1) Occurrence of TEAEs and treatment-related AEs according
    to NCI-CTCAE v5.0
    2) OS
    3) BOR according to RECIST 1.1 assessed by Investigator
    4) PFS according to RECIST 1.1 assessed by Investigator
    5) DOR assessed from CR or PR according to RECIST 1.1 assessed by IRC until PD, death,
    or last tumor assessment
    6) PK profile of M7824 in terms of Ceoi
    7) PK profile of M7824 in terms of
    Ctrough
    8) Immunogenicity as measured by ADA assays at Baseline and ontreatment
    1) Aparición de AAST y AA relacionados con el tratamiento conforme a CTCAE del NCI v 5.0
    2) SG
    3) MRG según RECIST 1.1 evaluada por el investigador
    4) SSP según RECIST 1.1 evaluada por el investigador
    5) DdR evaluada a partir de RC o RP según RECIST 1.1, evaluada por el CRI hasta la PE, la muerte o la última evaluación del tumor
    6) Perfil FC de M7824 en términos de Cfdi
    7)Perfil FC de M7824 en términos de Cvalle
    8) La inmunogenicidad se determinará mediante análisis de AAF al inicio y durante el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Time from random. to the last 12-week safety follow-up visit, expected at 47 months.
    2) From random. to assessment when 200 OS events occur, OS PA exp. at 49 months from first participant in the study
    3) Time from random. to planned final assessment for unconfirmed BOR, exp. 26 months.
    4) Time from random. to final assessm.PFS after 192 events at 37 months.
    5) Time from CR or PR to planned assessment after 192 PFS events, expected at 37 months.
    6,7) Predose samples at Weeks 1,3,5,7, then 6 weekly during treatment; postdose (within 30 min) samples at 6 weekly during treatment and up to study’s Safety Follow-up Visit at 28 days after last study intervention administ.
    8) From random. up to study’s Safety Folup Visit, defined as 28 days after last study intervention administr.
    1) Tpo dsd la aleator hasta la última VSeg de la seguridad, 47m.
    2) Tpo dsd la aleator hasta que se hayan producido 200 acontecimientos de SG; AP de SG, 49m desde la inclusión del 1 part.
    3) Tpo dsd la aleator hasta la eva. final planificada para la MRG no confr, 26m
    4) Tpo dsd la aleator hasta la evaluación final planificada para la SSP después de 192 acontecimientos, 37m
    5) Tpo desde RC o RP hasta el criterio de valor plan dps de 192 acontecimientos de SSP, 37m
    6,7 ) Muestras anteriores a la dosis en las semanas 1, 3, 5 y 7, y posteriormente cada 6sms durante el tto; muestras posteriores a la dosis (30 min) cada 6sem durante el tto y hasta la VSG de la seguridad al cabo de 28d dsd ultm adm
    8) Tiempo desde la aleatorización hasta la VSG de la seguridad, 28d después de la utl adm
    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 Yes
    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 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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    European Union
    Japan
    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 the study is defined as the date when 67% of participants have had an OS event.
    El final del estudio esta definido como la fecha en la que el 67% de pacientes han tenido un evento adverso
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 300
    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)
    After a participant has completed the study or has withdrawn early, participants may receive the care they and their physicians agree upon. Participants will be followed for survival and AEs as specified in the protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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