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    Summary
    EudraCT Number:2017-003151-34
    Sponsor's Protocol Code Number:ET17-093
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-13
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-003151-34
    A.3Full title of the trial
    A multicenter, randomised, open-label Phase II study to evaluate the clinical benefit of a post-operative treatment associating radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy.
    Etude multicentrique de Phase II, randomisée, menée en ouvert visant à évaluer le bénéfice clinique d’un traitement post-opératoire associant radiothérapie + Nivolumab + Ipilimumab versus radiothérapie + Capécitabine chez des patientes atteintes d’un cancer du sein triple négatif et présentant une maladie résiduelle après chimiothérapie néoadjuvante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial evaluating the benefit of a post-operative treatment associating radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy.
    Essai évaluant le bénéfice clinique d’un traitement post-opératoire associant radiothérapie + Nivolumab + Ipilimumab versus radiothérapie + Capécitabine chez des patientes atteintes d’un cancer du sein triple négatif et présentant une maladie résiduelle après chimiothérapie néoadjuvante.
    A.3.2Name or abbreviated title of the trial where available
    BreastImmune03
    A.4.1Sponsor's protocol code numberET17-093
    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 SponsorCentre Léon Bérard
    B.1.3.4CountryFrance
    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 supportBristol-Myers Squibb
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33426556824
    B.5.5Fax number+33469856182
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameNivolumab
    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 INNNIVOLUMAB
    D.3.9.1CAS number NIVOLUMAB
    D.3.9.2Current sponsor codeET17-093
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Yes
    D.2.1.1.1Trade name Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameIpilimumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Capecitabine
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCapecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy
    Cancer du sein triple négatif et présentant une maladie résiduelle après chimiothérapie néoadjuvante
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Cancer du sein
    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 HLT
    E.1.2Classification code 10006292
    E.1.2Term Breast neoplasms unspecified malignancy
    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 evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in TNBC patients with residual disease after neoadjuvant chemotherapy.
    Evaluer le bénéfice clinique d’un traitement combinant Nivolumab + Ipilimumab + radiothérapie versus Capécitabine + radiothérapie chez des patientes atteintes de cancer du sein triple négatif avec une maladie résiduelle après chimiothérapie néoadjuvante en post opératoire.
    E.2.2Secondary objectives of the trial
    To further assess the clinical impact of the proposed combination in the target population.
    To further evaluate the safety profile of the proposed combination in the target population.
    To assess the impact of the proposed combinations on patient’ quality of life in the target population.
    Evaluer l’impact clinique de la combinaison proposée sur la population cible
    Définir le profil de tolérance de la combinaison sur la population cible
    Evaluer l’impact de la combinaison proposée sur la qualité de vie de la population cible
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To define the molecular characteristics of the tumor’ patients (Mutational profiles of tumors (Whole Exome seq), Copy Number alterations and LOH (WES and CytoscanHD microarrays), Mutational burden and neo-epitope, Molecular Subtyping of TNBC (RNAseq). Circulating tumor DNA detection and anlysis will be also performed.
    - To assess the Immune infiltration using RNAseq (immune signature) and multiparametric immunofluorescence
    - To perform Immune monitoring of circulating immune cells and circulating tumor cells ( frequency and phenotype of immune cell subsets, functional competence of immune cell subsets, levels of circulating growth factors and cytokines, presence in plasma of soluble PDL1 and PDL2.
    Identification des profils mutationnels et transcriptomiques (Whole exome sequencing, CytoscanHD microarrays),
    Caractérisation de l’infiltrat immunitaire par immunofluorescence.
    Les analyses suivantes sont prévues sur les échantillons sanguins collectés au cours du traitement afin d’évaluer l’impact de la stratégie thérapeutique proposée sur :
    1.La fréquence, le phénotype et la fonction des cellules immunes circulantes,
    2.Les taux de cytokines et de facteurs de croissance plasmatiques,
    3.les taux de PDL1 et PDL2 soluble,
    4.Le taux d’ADN tumoral circulant
    E.3Principal inclusion criteria
    Female patient > 18 years of age on day of signing informed consent form.
    Histologically proven TNBC defined as follows:
    HER2 negativity must be confirmed by one of the following:
    - Fluorescence in situ hybridization (FISH) negative (FISH ratio <2.2), or
    - Immunohistochemistry (IHC): 0-1+, or
    - IHC 2-3+ and FISH-negative (FISH ratio <2.2).
    Less than 1% of cells stained by immunohistochemestry (IHC) for ER and PR as per ASCO guidelines.
    TNBC previously treated by :
    Standard neoadjuvant chemotherapy containing anthracycline and taxanes (other drugs may be acceptable following discussion with the Sponsor, with the exclusion of Capecitabine), and
    Surgery.
    TNBC patients currently treated by post-operative radiotherapy as per standard and/or institutional guidelines: radiotherapy has to be initiated one week (± 3 days) before C1D1.
    No radiological evidence of metastatic disease documented by a CT-Scan of Chest abdomen and pelvis.
    Residual disease with RCB of Class III documented before randomisation using the surgery specimen.
    Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report.
    Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
    Adequate end organ and bone marrow function.
    Femme âgée d’au moins 18 ans à la date de signature du consentement.
    Diagnostic de cancer du sein triple négatif confirmé histologiquement et défini par :
    Un statut HER2 négatif selon les critères ci-dessous :
    - Hybridation in situ en fluorescence (FISH) négative (FISH ratio < 2.2), ou
    - Immunohistochimie (IHC): 0-1+, ou
    - IHC 2-3 + et FISH-négative (FISH ratio < 2.2).
    Moins d’1% des cellules marquées pour les récepteurs aux œstrogènes (RO) et à la progestérone (RP) par ICH selon les recommandations de l’ASCO.
    Patiente atteinte de cancer du sein triple négatif précédemment traitée par :
    Chimiothérapie néoadjuvante standard à base d’anthracycline et de taxane (d’autres chimiothérapies peuvent être acceptées après discussion avec le promoteur à l’exception de la capécitabine), et Chirurgie.
    Patiente atteinte d’un cancer du sein triple négatif actuellement traitée ou devant être traitée par radiothérapie en post opératoire (la radiothérapie doit commencer 1 semaine (± 3 jours) avant le C1J1).
    Aucune évidence radiologique de métastases documentées par un scanner thoraco-abdomino-pelvien.
    Maladie résiduelle avec un RCB de classe III documentée avant la randomisation après analyse de la pièce opératoire.
    Disponibilité de matériel tumoral représentatif archivé fixé en formol et inclus en paraffine (FFPE) issu de la pièce opératoire et de son compte rendu histologique.
    Statut de performance (PS) de 0 ou 1 selon l’échelle ECOG.
    Fonction normale des organes majeurs et de la moelle osseuse selon les critères définis dans le protocole.
    E.4Principal exclusion criteria
    Patient has a metastatic breast cancer.
    Patient has previously received therapy with an anti- PD-1, anti- PD-L1, or anti-CTLA4 or any other immunotherapies.
    Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone curative therapy and other completely treated prior malignancy if no evidence of disease for ≥ 2 years.
    Patient presents a contraindication to Nivolumab or Ipilimumab treatment as per respective SPC including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody.
    Patient presents a contraindication to Capecitabine treatment as per SPC including i) History of severe and unexpected reactions to fluoropyrimidine therapy, 2) Hypersensitivity to Capecitabine or to any of the excipients listed in SPC or fluorouracil, 3) Patients with known complete absence of dihydropyrimidine dehydrogenase activity, 4) Treatment with sorivudine or its chemically related analogues, such as brivudine, 5) any contraindication listed in respective SPC.
    Patient has active autoimmune disease that has required systemic treatment in the past 3 months before C1D1 or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents.
    Patiente présentant un cancer du sein métastatique.
    Patiente ayant déjà reçu un anti- PD-1, anti- PD-L1, ou anti-CTLA4 ou toute autre immunothérapie.
    Patiente présentant un autre type de cancer en progression ou nécessitant un traitement à l’exception des carcinomes basocellulaires, cancers de la peau non mélanomateux ou cancers du col de l’utérus in situ traités à visée curative ou tout autre cancer complètement guéri et sans évidence de maladie depuis au moins 2 ans.
    Patiente présentant une contre-indication au Nivolumab ou à l’Ipilimumab selon leur RCP respectifs, ou une hypersensibilité connue à l’un de ces traitements ou un antécédent de réaction d’hypersensibilité sévère à un anticorps monoclonal.
    Patiente présentant une contre-indication à la capécitabine incluant : 1) antécédent de réaction sévère et inattendue au fluoropyrimidine, 2) hypersensibilité à la Capécitabine ou tout excipient listé dans le RCP ou au fluorouracile, 3) déficit en dihydropyrimidine déshydrogénase (DPD), 4) traitement concomitant par Sorivudine ou par un analogue comme la brivudine, 5) toute contre-indication listée sur le RCP .
    Patiente présentant une maladie autoimmune active nécéssitant/ayant nécessité un traitement systémique dans les 3 derniers mois avant le C1J1 ou maladie autoimmune connue ou syndrome qui nécessite un traitement par des stéroïdes à une dose supérieure à 10 mg/jour de prednisone ou un corticostéroïde équivalent ou tout autre traitement immunosuppresseur.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival
    Survie sans maladie
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 ans
    E.5.2Secondary end point(s)
    Overall Survival .
    Local-regional recurrence rate.
    Distant metastasis rate.
    Incidence of AEs, related AEs, irAE, Grade ≥ 3 AEs, AESI, SAEs, SUSARs graded using NCI CTCAE 5.0
    Patients reported outcomes EORTC QLQ-C30, EORTC QLQ BR-23, EORTC QLQ FA-13 Fatigue, GAD7 patient self-rating mood scale.
    Survie globale, Taux de rechute local, Taux de rechute à distance.
    Incidence de tous les EI, des EI reliés au traitement, les EI liés à l’immunité, EI d’intérêt particulier, EIG, et EIGI gradés selon la classification NCI CTCAE 5.0, scores des questionnaires suivants: EORTC QLQ-C30, EORTC QLQ BR-23, EORTC QLQ FA-13 Fatigue, GAD7 patient self-rating mood scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 ans
    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 Yes
    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) 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 concerned8
    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 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
    Last Patient Last Visit (defined as either the date of the last visit of the
    last patient to complete the study, or the date at which the last data
    point from the last patient, which is required for statistical analysis is
    received, whichever is the later date)
    Dernière visite du dernier patient (définie comme la date la plus
    tardive soit de visite du dernier patient dans l'étude soit la date de
    réception des données du dernier patient au dernier temps requis pour
    l'analyse statistique)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days
    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: 70
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 28
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state98
    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)
    At the physician discretion
    A la discrétion du médecin
    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 Decision2019-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
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