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    Summary
    EudraCT Number:2017-004417-42
    Sponsor's Protocol Code Number:MK3475-587
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-13
    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 number2017-004417-42
    A.3Full title of the trial
    A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.
    Sperimentazione di estensione di fase III, multicentrica, in aperto per valutare la sicurezza e l¿efficacia a lungo termine in pazienti con tumori avanzati attualmente in trattamento o in follow-up in una sperimentazione con pembrolizumab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension Study for Participants With Advanced Tumors in Pembrolizumab Trials
    Studio di estensione per pazienti con tumori avanzati partecipanti a sperimentazioni cliniche con pembrolizumab.
    A.3.2Name or abbreviated title of the trial where available
    Extension Study for Participants With Advanced Tumors in Pembrolizumab Trials
    Studio di estensione per pazienti con tumori avanzati partecipanti a sperimentazioni cliniche con pe
    A.4.1Sponsor's protocol code numberMK3475-587
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03486873
    A.5.4Other Identifiers
    Name:IND NumberNumber:110080
    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. UNA SUSSIDIARIA DI 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 supportMerckSharp&DohmeCorp, 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 organisationMSD Italia Srl
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00390636191371
    B.5.5Fax number00390636380371
    B.5.6E-mailgcto.italy@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 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 namePembrolizumab
    D.3.2Product code MK-3475
    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.3.9.4EV 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) 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.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
    Advanced Tumors
    Tumori avanzati
    E.1.1.1Medical condition in easily understood language
    Advanced Tumors/Cancer
    Tumori/Carcinomi avanzati
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the OS.
    Stimare la sopravvivenza globale (OS).
    E.2.2Secondary objectives of the trial
    - To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumab based combination.
    - To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment.
    -Stimare la durata della risposta (DOR) e la durata della risposta completa (DOCR) in base ai criteri di valutazione usati nella sperimentazione originale secondo la valutazione dello sperimentatore per i partecipanti che hanno ricevuto o stanno ricevendo il Primo Corso di trattamento sperimentale con pembrolizumab o una combinazione a base di pembrolizumab.
    -Valutare la sicurezza e la tollerabilit¿ di pembrolizumab o di una combinazione a base di pembrolizumab nei partecipanti che lo ricevono come trattamento sperimentale nella fase di Primo o Secondo Corso.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Merck will also analyse microbiome from stool.
    The broad objective of the stool microbiome sub-study is to explore new biomarkers predictive of pembrolizumab response.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Merck analizzer¿ anche il microbioma dalle feci.
    L'obiettivo generale del sottostudio del microbioma delle feci ¿ quello di identificare nuovi biomarcatori predittivi della risposta di pembrolizumab.
    E.3Principal inclusion criteria
    1. Participants that are currently enrolled in MSD-sponsored pembrolizumab trials and are receiving trial treatment or in a Follow-up Phase at the time KN587 is open. The parent trials must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into KN587.
    2. The participant (or legally acceptable representative if applicable) provides informed consent for the trial and agrees to follow study procedures.
    1. I partecipanti attualmente arruolati nelle sperimentazioni con pembrolizumab sponsorizzate da MSD e che ricevono il trattamento sperimentale o si trovano in una fase di follow-up al momento in cui KN587 è aperto. Le sperimentazioni originali devono aver completato tutte le eventuali richieste e sottomissioni regolatorie, o devono aver soddisfatto il/i relativo/i endpoint primario/i prima che tutti i loro partecipanti accedano a KN587.
    2.Il partecipante (o il rappresentante legalmente accettabile, se applicabile) fornisce il consenso informato per la sperimentazione e accetta di seguire le procedure dello studio.
    E.4Principal exclusion criteria
    There are no exclusion criteria to participate in KN587.
    Non vi sono criteri di esclusione per la partecipazione a KN587.
    E.5 End points
    E.5.1Primary end point(s)
    OS is defined as the time from randomization or start of trial treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last follow-up.
    La sopravvivenza globale (OS) è definita come l’intervallo di tempo dalla randomizzazione o dall’inizio del trattamento sperimentale per i partecipanti non randomizzati (nello studio originale) fino al decesso dovuto a qualsiasi causa. I partecipanti senza decesso documentato al momento dell’analisi saranno censiti alla data dell’ultimo follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    No planned interim analyses will be performed. Periodic summaries of study results will be produced. Subjects will be followed until death.
    Non saranno effettuate analisi ad interim pianificate. Saranno prodotti dei riassunti periodici dei risultati dello studio. I soggetti saranno seguiti fino alla morte.
    E.5.2Secondary end point(s)
    - DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response on the parent trial until
    earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment.
    -DOCR is determined by disease assessment and is defined as the time from the date of CR on the parent trial until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment.
    - Participants who experience SAEs, AEOSI or ECI.
    -La durata della risposta (DOR) ¿ determinata in base alla valutazione della malattia ed ¿ definita come l¿intervallo di tempo dalla prima data di risposta valida nella sperimentazione originale fino alla prima data di progressione della malattia o al decesso dovuto a qualsiasi causa, a seconda di quale evento si verifica prima in base alla valutazione dello sperimentatore.
    -La durata della risposta completa (DOCR) ¿ determinata in base alla valutazione della malattia ed ¿ definita come l¿intervallo di tempo dalla data della risposta completa (CR) nella sperimentazione originale fino alla prima data di progressione della malattia o al decesso dovuto a qualsiasi causa, a seconda di quale evento si verifica prima in base alla valutazione dello sperimentatore.
    -Partecipanti che manifestano eventi avversi seri (SAE), eventi avversi di interesse speciale (AEOSI) o eventi di interesse clinico (ECI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    No planned interim analyses will be performed. Periodic summaries of study results will be produced. Subjects will be followed until death.
    Non saranno effettuate analisi ad interim pianificate. Saranno prodotti dei riassunti periodici dei risultati dello studio.I soggetti verranno seguiti fino alla morte.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Chile
    Colombia
    Israel
    Korea, Republic of
    New Zealand
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The overall study ends when the last participant completes the last study-related phone-call or visit, withdraws from the study or is lost to follow-up (ie, the participant is unable to be contacted by the investigator).
    Lo studio complessivo termina quando l'ultimo partecipante completa l'ultima telefonata o visita dello studio, si ritira dallo studio o ¿ irreperibile
    al follow-up (cio¿, il partecipante non pu¿ essere contattato dallo sperimentatore).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 2100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 345
    F.4.2.2In the whole clinical trial 1955
    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)
    None
    Nessuno
    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 Decision2018-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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