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    Summary
    EudraCT Number:2018-001517-32
    Sponsor's Protocol Code Number:MS200647-0037
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio controllato di fase II, multicentrico, randomizzato, in aperto di M7824 rispetto a pembrolizumab come trattamento di prima linea in pazienti con carcinoma polmonare non a piccole cellule esprimente PD-L1 in stadio avanzato
    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
    RCT di fase II su M7824 vs pembrolizumab nel NSCLC 1L
    A.3.2Name or abbreviated title of the trial where available
    1L NSCLC Phase II RCT M7824 vs Pembrolizumab
    RCT di fase II su M7824 vs pembrolizumab nel NSCLC 1L
    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+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.com
    D. IMP Identification
    D.IMP: 1
    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 (EU/1/15/1024/001)
    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.3.1Product name.
    D.3.2Product code [.]
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 (EU/1/15/1024/002)
    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.3.1Product namePembrolizumab
    D.3.2Product code [Pembrolizumab]
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameM7824
    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.3.9.2Current sponsor codeMSB0011359C
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    carcinoma polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Non-small Cell Lung Cancer
    carcinoma polmonare non a piccole cellule
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    Valutare se M7824 migliora l’ORR rispetto a pembrolizumab nei partecipanti di prima linea con NSCLC avanzato con elevata espressione tumorale di PD-L1

    Valutare se M7824 migliora la PFS rispetto a pembrolizumab nei partecipanti di prima linea con NSCLC avanzato con elevata espressione tumorale di 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
    Sicurezza
    - Valutare la sicurezza e la tollerabilità di M7824 rispetto a pembrolizumab

    Efficacia
    - Valutare se M7824 migliora il tempo di sopravvivenza complessiva rispetto a
    pembrolizumab
    - ORR valutato dagli sperimentatori
    - PFS valutata dagli sperimentatori
    - Durata della risposta (DOR)

    Farmacocinetica (PK)
    - Caratterizzare il profilo PK di M7824

    Immunogenicità
    - Caratterizzare l’immunogenicità di M7824
    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 anni inclusi al momento della firma del consenso informato
    2. Diagnosi istologicamente confermata di NSCLC in stadio avanzato e:
    a. Non avere ricevuto precedente trattamento di terapia sistemica per il loro NSCLC di stadio avanzato/stadio IV. Il completamento del trattamento con chemioterapia citotossica, terapia biologica e/o radiazioni come parte di una terapia neoadiuvante/adiuvante è consentito finché la terapia non sia stata completata almeno 6 mesi prima della diagnosi di malattia metastatica.
    Conferma di risoluzione di effetti tossici della precedente chemioterapia neoadiuvante/adiuvante di grado = 1. In relazione a tossicità delle radiazioni o interventi chirurgici precedenti maggiori, i partecipanti dovranno essersi ripresi dagli effetti collaterali e/o dalle complicazioni.
    b. Avere una malattia misurabile in base ai criteri di valutazione della risposta nei tumori solidi (RECIST) 1.1
    c. Avere un’aspettativa di vita di almeno 3 mesi
    d. La disponibilità di materiale tumorale archiviato (< 6 mesi) o biopsie fresche prelevate nei 28 giorni (escluse le biopsie ossee) precedenti la prima dose è obbligatoria per determinare il livello di espressione di PD-L1 prima dell’arruolamento
    e. È necessario uno stato elevato di PD-L1
    (possono essere applicati altri criteri definiti dal protocollo)
    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 costimulation 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. Il tumore del partecipante presenta una mutazione sensibilizzante nel recettore del fattore di crescita epidermico (EGFR) (attivante),
    una traslocazione ALK, un riarrangiamento ROS1 o una mutazione BRAF V600E, se la terapia mirata è approvata a livello locale
    2. Ha subito un intervento chirurgico maggiore nelle 4 settimane precedenti la prima dose dell’intervento dello studio;
    ha subito una RT toracica di > 30 Gy nei 6 mesi precedenti la prima dose dello studio
    7. Reazioni note di grave ipersensibilità a mAB
    8. Ricezione di un trapianto di organo
    9. Presenta malattia polmonare interstiziale (ILD) O ha avuto un’anamnesi di polmonite che ha richiesto steroidi per via orale o EV
    10. Infezioni acute o croniche significative
    11. Presenta un’anamnesi o una prova corrente di qualsiasi condizione, terapia o anomalia di laboratorio che potrebbe confondere i risultati dello studio, interferire con la partecipazione per l’intera durata dello studio o non è nel migliore interesse del partecipante secondo il parere dello sperimentatore curante
    12. Ha ricevuto una precedente terapia con l’intervento di un anticorpo anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 o anti-antigene 4 dei linfociti T citotossici associati (CTLA-4)
    (inclusi ipilimumab o qualsiasi altro anticorpo o farmaco che mira specificamente alla costimolazione delle cellule T oppure vie di segnalazione del checkpoint).
    13. Precedente neoplasia maligna
    14. Presenta metastasi attive nel sistema nervoso centrale (SNC) che causano sintomi clinici o metastasi che necessitano di intervento terapeutico, e/o meningite carcinomatosa
    15. Malattia autoimmune attiva che ha richiesto un trattamento sistemico nell’ultimo anno O che sta ricevendo una terapia steroidea sistemica < 3 giorni precedenti la prima dose dell’intervento dello studio o qualsiasi altra forma di farmaco immunosoppressore.
    16. Si prevede che richiederà qualsiasi altra forma di terapia antineoplastica sistemica o localizzata durante lo studio (inclusa la terapia di mantenimento con un altro agente per NSCLC, RT e/o resezione chirurgica)
    (possono essere applicati altri criteri definiti dal protocollo)
    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) Migliore risposta complessiva (BOR) secondo i criteri RECIST 1.1 valutata dal Comitato di revisione indipendente (IRC)
    2) Sopravvivenza libera da progressione (PFS) secondo i criteri RECIST 1.1 valutata dall’IRC
    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) Tempo trascorso dalla randomizzazione alla valutazione finale programmata della
    BOR non confermata, prevista a 26 mesi.
    2) Tempo trascorso dalla randomizzazione alla valutazione finale programmata della PFS dopo 192 eventi prevista a 37 mesi.
    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) Comparsa di eventi avversi emergenti dal trattamento (TEAE) ed eventi avversi (EA) correlati al trattamento secondo i criteri terminologici comuni per gli eventi avversi del National Cancer Institute (NCI-CTCAE), v5.0
    2) Sopravvivenza complessiva (OS)
    3) BOR valutata dallo sperimentatore secondo i criteri RECIST 1.1
    4) PFS valutata dallo sperimentatore secondo i criteri RECIST 1.1
    5) Durata della risposta (DOR) valutata a partire dalla risposta completa (CR) o risposta parziale (PR) secondo i criteri RECIST 1.1 in base alla valutazione dell’IRC
    fino a progressione di malattia (PD), decesso
    o ultima valutazione del tumore
    6) Profilo farmacocinetico (PK) di M7824 in termini di concentrazione alla fine dell’infusione (Ceoi)
    7) Profilo PK di M7824 in termini di concentrazione alla fine dell’intervallo di somministrazione (Ctrough)
    8) Immunogenicità misurata mediante dosaggi degli anticorpi anti-farmaco (ADA) al basale e durante il trattamento
    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)Tempo trasc dalla rand all’ult vis di f-up di sicurez a 12 sett,prev a 47 mesi2) Dalla random alla valutaz una volta verific200 ev di OS,[PA]OS prev a 49mesi dal primo partecip allo studio3) Tempo trasc dalla randomiz alla valutaz fin program della BOR non conferm, prev a 26 mesi4) Tempo trasc dalla random alla valutaz fin della PFS dopo 192 ev a 37 mesi5) Tempo trasc dalla CR o PR alla valut program dopo 192 ev di PFS, prev a 37 mesi.6,7) Camp pre-dose alle Sett 1,3,5,7 e successiv ogni 6 sett durante il tratt;camp post-dose (entro 30 min) ogni 6 sett dur il trattam e fino alla vis di f-up di sicurez dello studio a 28 g dopo l’ult somministr dell’interv dello studio8) Dalla rand fino alla vis di f-up di sicurez dello studio, indicata a 28 g dopo l’ult somministr dell’interv dello studio
    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 Yes
    E.8.1.7.1Other trial design description
    Other medicinal product(s)
    Other medicinal product(s)
    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 concerned7
    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 Information not present in EudraCT
    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.
    La fine dello studio è definita come la data in cui il 67% dei partecipanti ha presentato un evento di OS.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 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 state14
    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.
    Una volta che un partecipante abbia completato lo studio o si sia ritirato anticipatamente, i partecipanti possono ricevere la cura concordata con i propri medici.
    I partecipanti saranno seguiti per la sopravvivenza e gli EA come specificato nel Protocollo.
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-05-07
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