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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2016-003819-36
    Sponsor's Protocol Code Number:MK3475-586
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-04-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003819-36
    A.3Full title of the trial
    Combining SBRT and pembrolizumab in early stage non-small cellular lungcancer patients planned for surgery: exploring safety and immunological proof of principle.
    De combinatie van stereotactische radiotherapie (SABR) en immuuntherapie bij patiënten met niet-kleincellig longkanker in een vroeg stadium – studie naar de veiligheid en de immunologische ‘proof of principle’.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combining radiotherapy and immunotherapy in early stage non-small-cell lung cancer patients: exploring safety and immunological proof of principle.
    De combinatie van hoge dosis radiotherapie (SABR) en immuuntherapie bij patiënten met een vroeg stadium niet-kleincellig longkanker
    A.4.1Sponsor's protocol code numberMK3475-586
    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 SponsorVU Medical Centre
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU Medical Centre
    B.5.2Functional name of contact pointSecretariaat Longziekten
    B.5.3 Address:
    B.5.3.1Street Addressde Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204444782
    B.5.5Fax number0031204444328
    B.5.6E-maillong@vumc.nl
    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.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    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) 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 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 name89Zr-pembrolizumab
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive namePembrolizumab
    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 number2
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early stage (T1N0 and T2N0) non-small cell lung cancer
    Vroeg stadium (T1N0 en T2N0) niet-kleincellig longcarcinoom
    E.1.1.1Medical condition in easily understood language
    Lungcancer
    Longkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify the immunological response to combined SBRT and pembrolizumab treatment in early stage NSCLC. Expression rates and activation states of immune effector subsets will be assessed in tumor core biopsy specimens, peripheral blood and tumor draining lymph nodes (TDLNs) by means of EBUS derived fine needle aspirates. Samples will be taken before and after SBRT +/- pembrolizumab treatment and at surgery.
    Het identificeren van de immunologische respons op combinatie behandeling met SABR en pembrolizumab in patiënten met vroeg stadium niet-kleincellig longkanker. De mate van expressie en activatie van immuun effector cellen wordt onderzocht in tumorweefsel biopten, perifeer bloed en tumor drainerende lymfeklieren (TDLNs) door middel van via EBUS verkregen fijne naald aspiraties. Het weefsel en bloed wordt afgenomen voor en na de combinatie behandeling met SBRT en pembrolizumab, en tijdens de operatie.
    E.2.2Secondary objectives of the trial
    To assess the safety of combined SBRT and pembrolizumab treatment.
    To assess uptake (visual and quantitatively, expressed as SUVmax, SUVmean and SUVpeak) of radiolabeled pembrolizumab in the tumor and lymph nodes by use of PET.
    To evaluate radiation induces changes to healthy lung tissue after combined SBRT and pembrolizumab treatment in the resected lung lobe.
    Het onderzoeken van de veiligheid van de combinatiebehandeling met radiotherapie (SABR) en pembrolzimab.
    Het meten van opname van radioactief gelabeld pembrolizumab (visueel en kwantitatief, uitgedrukt als SUVmac, SUVmean en SUVpeak) in de tumor en lymfeklieren met behulp van PET scans.
    Het evalueren van radiatie geïnduceerde veranderingen aan het gezonde longweefsel in geresecteerd longweefsel na combinatiebehandeling met SABR en pembrolizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    histologically histologically or cytologically confirmed diagnosis of early stage (T1bN0 and T2aN0) peripherally located NSCLC, eligible for surgical resection. Highly suspected NSCLC is defined as an a priori change of >85% that the lesion is malignant, according to the publication of Herder et al. (59)
    Be willing and able to provide written informed consent/assent for the trial.
    Be 18 years of age or older on day of signing imformed consent.
    Have measurable disease based on RECIST 1.1.
    Must provide tissue from a core or excisional biopsy of the primary tumor lesion.
    Have a performance status of 0-1 on the ECOG Performance Scale.
    Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
    Female subject of childbearing potential should have a negative urine or serum pregnancy 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.
    Female subjects of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not ben free form menses for >1 year.
    Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
    histologisch dan wel cytologisch bevestigde diagnose van vroeg stadium (T1nN0 en T2aN0) perifeer gelokaliseerde NSCLC, geschikt voor chirurgische resectie. Sterk verdachte NSCLC is gedefinieerd als een a priori verandering van >85% dat de laesie maligne is, volgens de publicatie van Herder et al. (59)
    Patienten dienen wilsbekwaam te zijn en in staat het informed consent te tekenen.
    18 jaar of ouder op de dag van het tekenen van informed consent.
    Bereid zijn tot het ondergaan van een biopt van de tumor.
    Een performance status van 0-2 hebben op de ECOG performance schaal.
    Adequate orgaanfunctie hebben, blijkend uit voldoende adequate labwaarden die getest zijn binnen 10 dagen voor de start van behandeling.
    Vrouwelijke proefpersonen die in potentie zwanger kunnen zijn zouden een negatieve urine of serum zwangerschapstest moeten hebben in de 72 uur voor aanvang van de eerste gift van het studie medicament. Indien de urine test positief is, of niet bevestigd kan worden als negatief, dan is een serum zwangerschapstest vereist.
    Vrouwelijke proefpersonen die in potentie zwanger kunnen zijn moeten bereid zijn om twee methoden van anticonceptie te gebruiken, of gesteriliseerd te zijn, of zich onthouden van heteroseksuele activiteit voor de duur van de studie tot 120 dagen na de laatste gift van de studie medicatie.
    Mannelijke patiënten moeten bereid zijn tot een adequate methode van anticonceptie gedurende de eerste gift van het studie medicament tot 120 dagen na de laatste gift van de studie medicatie.
    E.4Principal exclusion criteria
    Is currently participating in or has participated in a study of an investigational agent or using investigational device within 4 weeks of the first dose of treatment.
    Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days proor to the first dose of trial treatment.
    Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e. grade 1 or lower, or at baseling) from adverse events due to agents administered more than 4 weeks earlier.
    Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e. grade 1 or lower at baseline) from adverse events due to a previously administered agent.
    Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cel carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented histroy of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
    Has a history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
    Has an active infection requiring systemic therapy.
    Has a histroy or current evidence of any condition ,therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the bst interest of the subject to participate, in the opinion of the treating investigator.
    Has known psychiatric or substance abude disorders that would interfere with cooperation with the requirements of the trial.
    Is pregnant or breastfeedig, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
    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).
    Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected).
    Has received a live vaccine within 30 days prior to the first dose of trial treatment.
    Neemt deel aan of heeft deelgenomen aan een studie met een experimenteel middel of hulpmiddel in de vier weken voor de eerste gift van de studie.
    Heeft een immuundeficiëntie of ontvangt systemische steroïden in een dosis hoger dan een equivalent van 10 mg prednison per dag of elke andere vorm van immuunsuppressiva in de 7 dagen voorafgaand aan de eerste gift van het studiemedicament.
    Heeft een monoclonaal antilichaam gehad in de vier weken voorafgaand aan studie dag 1 of is niet hersteld van bijwerkingen van middelen die vier weken eerder zijn gegeven.
    Heeft chemotherapie, targeted small molecule therapie of radiotherapie gehad in de twee weken voor studie dag 1 of is niet hertseld van de bijwerkingen ten gevolge van die behandeling.
    Heeft een tweede primaire tumor die progressie vertoont of actieve behandeling vereist. Dit geldt niet voor basaalcelcarcinoom van de huid, plaveiselcelcarcinoom van de huid, of in situ cervix carcinoom, waarvoor in intentie curatieve therapie is gegeven.
    Heeft een actieve auto-immuunziekte welke systemische therapie heeft vereist in de afgelopen 3 maanden of bij een voorgeschiedenis met een klinisch ernstige auto-immuunziekte, of een syndroom dat behandeling met systemische steroïden of immunosuppressiva vereist. Patienten met vitiligo of voorbijgaande astma/atopie op kinderleeftijd vormen en uitzondering op deze regel. Patienten met intermitterend gebruik van bronchodilatoren of lokale steroid injecties worden niet geexcludeerd van de studie. Patienten met stabiele hypothyreoidie op hormoon substitutie of het syndroom van Sjögren worden niet geexcludeerd van de studie.
    Heeft een voorgeschiedenis van (niet-infectieuze) pneumonitis waarvoor steroïden waren vereist.
    Heeft aanwijzingen voor interstitiële longziekten of een actieve, niet infectieuze pneumonitis.
    Heeft een actieve infectie welke systemische therapie vereist.
    Heeft een voorgeschiedenis of momenteel aanwijzingen voor enige conditie, therapie of abnormale labuitslagen, welke de resultaten van deze studie kunnen beïnvloeden, interfereren met deelname aan de studie voor de gehele duur van de studie of is, volgens de behandelend onderzoeker, niet in het belang van de patient om deel te nemen.
    Is bekend met psychiatrische ziekte, of middelenmisbruik wat zou interfereren met de cooperatie van de vereisten van de studie.
    Is zwanger of geeft borstvoeding, of is in verwachting van kinderen binnen de projecteerde duur van de studie, te starten binnen de pre-screening of screening vsisite gedurende 120 dagen na de laatste gift van de studiemedicatie.
    Heeft eerdere therapie ontvangen met anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 of anti-cytotoxische T-lymfocyten-geassocieerd antigen-4 (CTLA-4) antilichaam (inclusief ipilimumab of andere antilichamen of medicijnen specifiek gericht op T-cellen co-stimulatie of checkpoint pathways).
    Heeft een voorgeschiedenis van HIV.
    Is bekend met actieve Hepatitis B of C.
    Is gevaccineerd met een levend vaccin in de 30 dagen voor de eerste gift van het studiemedicament.
    E.5 End points
    E.5.1Primary end point(s)
    Examination of tumor core biopsies and resection material. FACS analysis on EBUS-FNA of tumor draining lymphnodes (TDLNs) and peripheral blood to detect immunomodulation.
    Onderzoek van tumorbiopten en resectie materiaal.
    Het uitvoeren van een FASC analyse op door middel van EBUS verkregen fijne naald aspiraties van tumor drainerende lymfeklieren (TDLNs) en perifeer bloed om immuunmodulatie te detecteren.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 months after inclusion
    10 months after inclusion
    E.5.2Secondary end point(s)
    Assessment of clinical signs of radiation pneumonitis.
    The correlations of in-vivo PD-1 expression, quantified by immune-PET, with tissue and blood based immune-parameters.
    Onderzoek naar de klinische tekenen van radiatie pneumonitis.
    Het identificeren van een correlatie tussen in-vivo PD-1 expressie, gekwantificeerd met behulp van immuno-PET, en immuun-parameters uit weefsel en bloed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 months after inclusion
    10 months after inclusion
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 Yes
    E.8.2.3.1Comparator description
    SABR alleen
    SABR alone
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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
    Geen
    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 Decision2017-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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