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    Summary
    EudraCT Number:2018-002939-21
    Sponsor's Protocol Code Number:AARON
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-04
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-002939-21
    A.3Full title of the trial
    An Open-Label Phase II Study of Relatlimab (BMS-986016) with Nivolumab (BMS- 936558) in Combination with 5-Azacytidine for the Treatment of Patients with Refractory/Relapsed Acute Myeloid Leukemia and Newly Diagnosed Older Acute Myeloid Leukemia Patients
    Open-Label-Phase II-Studie zur Anwendung von Relatlimab (BMS-986016) und Nivolumab (BMS-936558) in Kombination mit 5-Azacitidin zur Behandlung von Patienten mit refraktärer/rezidivierter Akuter Myeloischer Leukämie und von älteren Patienten mit neu diagnostizierter Akuter Myeloischer Leukämie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Relatlimab, Nivolumab and 5-Azacytidine in Patients with AML
    Relatlimab, Nivolumab und 5-Azacitidin bei Patienten mit AML
    A.3.2Name or abbreviated title of the trial where available
    AARON
    AARON
    A.4.1Sponsor's protocol code numberAARON
    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 SponsorKlinikum der Universität München
    B.1.3.4CountryGermany
    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 GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Universität München
    B.5.2Functional name of contact pointTranslational Cancer Immunotherapy
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989440073133
    B.5.5Fax number+4989440076133
    B.5.6E-mailveit.buecklein@med.uni-muenchen.de
    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 nameRelatlimab
    D.3.2Product code BMS-986016
    D.3.4Pharmaceutical form Concentrate for dispersion 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 INNRelatlimab
    D.3.9.2Current sponsor codeBMS-986016
    D.3.9.4EV Substance CodeSUB168199
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Subjects with Acute myeloid leukemia
    Patienten mit akuter myeloischer Leukämie
    E.1.1.1Medical condition in easily understood language
    Subjects with relapsed or refractory (r/r) Acute myeloid leukemia (AML) or Patients aged ≥65 years with previously untreated AML who are unfit for or decline standard induction therapy.
    Patienten mit rezidivierter oder refraktärer akuter myeloischer Leukämie (AML) oder Patienten ≥65 Jahre mit AML, die für eine Standard-Induktionschemotherapie nicht in Frage kommen oder diese ablehnen
    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 LLT
    E.1.2Classification code 10001941
    E.1.2Term AML
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Lead-in-phase:
    Maximum tolerated dose and dose-limiting toxicities of relatlimab in combination with nivolumab and 5-azacytidine in patients with R/R AML
    Expansion phase:
    • Objective response rate to treatment with relatlimab + nivolumab + 5- azacytidine in patients with R/R AML
    • ORR to treatment with relatlimab + nivolumab + 5- azacytidine in older patients (≥65 years) with newly diagnosed AML
    Lead-in-Phase:
    • Bestimmung der maximal tolerablen Dosis (MTD) und dosislimitierender Toxizitäten (DLT) von Relatlimab in Kombination mit Nivolumab und 5-Azacitidin bei Patienten mit r/r AML.
    Expansionsphase:
    • Bestimmung der Gesamtansprechrate (overall response rate, ORR) unter Therapie mit Relatlimab + Nivolumab + 5- Azacitidin bei Patienten mit r/r AML.
    • Bestimmung der ORR unter Therapie mit Relatlimab + Nivolumab + 5-Azacitidin bei Patienten ≥65 Jahren mit neu diagnostizierter AML.
    E.2.2Secondary objectives of the trial
    • % of grade I/II and grade III/IV toxicities for patients with R/R AML on therapy with relatlimab + nivolumab + 5- azacytidine
    • % of grade I/II and grade III/IV toxicities for older patients with newly diagnosed AML on therapy with relatlimab + nivolumab + 5-azacytidin
    • Number of patients with R/R AML who achieve a HI in platelets, hemoglobin, or ANC on therapy with relatlimab + nivolumab + 5-azacytidine
    • Number of patients with R/R AML who achieve ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine.
    • Number of older patients with newly diagnosed AML who achieve an HI in platelets, hemoglobin, or ANC on therapy with relatlimab + nivolumab + 5-azacytidine
    • Number of older patients with newly diagnosed AML who achieve ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine
    • Duration of response, DFS, and OS of patients with R/R AML treated with relatlimab + nivolumab + 5-azacytidine
    • Bestimmung der Sicherheit der Therapie mit Relatlimab + Nivolumab + 5-Azacitidin bei Patienten mit r/r AML
    • Bestimmung der Sicherheit der Therapie mit Relatlimab + Nivolumab + 5-Azacitidin bei Patienten ≥65 Jahren mit neu diagnostizierter AML
    • Bestimmung der Anzahl an Patienten mit r/r AML, die eine hämatologische Verbesserung (hematologic improvement, HI) oder eine Reduktion des Blastenanteils um ≥50% unter Therapie mit Relatlimab + Nivolumab + 5-Aza erreichen.
    • Bestimmung der Anzahl an Patienten ≥65 Jahren mit neu diagnostizierter AML, die eine HI oder eine Reduktion des Blastenanteils um ≥50% unter Therapie mit Relatlimab + Nivolumab + 5-Aza erreichen.
    • Bestimmung der Dauer des Ansprechens, des erkrankungsfreien Überlebens und des Gesamtüberlebens bei Pat. mit r/r AML unter Therapie mit Relatlimab + Nivolumab + 5-Aza.
    • Bestimmung der Dauer des Ansprechens, DFS und OS bei Pat. ≥65 Jahren mit neu diagnostizierter AML unter Therapie mit Relatlimab + Nivolumab + 5-Aza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort 1 (R/R AML):
    • Patients with AML who have failed first line therapy (other than hydroxyurea) or patients who have relapsed after achieving a CR, CRp, or CRi.
    • Patients with AML who have failed up to one prior salvage therapy (i.e. salvage 1 or 2 status) will also be eligible. Allogeneic stem cell transplant for patients in remission at the time of transplant will not be considered a salvage regimen. Hydroxyurea if used alone will not be considered a salvage regimen.
    Cohort 2 (frontline older AML):
    • Patients aged ≥65 years with previously untreated AML who are unfit for or decline standard induction therapy.
    • Prior therapy with hydroxyurea, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however, prior therapy with chemotherapy agents for the disease under study is not allowed.
    All Cohorts:
    • Age ≥18 years
    • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
    • Adequate organ function
    • Patients must provide written informed consent
    Kohorte 1 (r/r AML):
    • Patienten mit AML, die unter Erstlinientherapie (ausgenommen Hydroxyurea) ein Therapieversagen zeigen oder Patienten, die ein Rezidiv nach Erreichen einer CR/CRi erleiden und unter bis zu einer vorhergehenden Salvagetherapie ein Therapieversagen zeigen
    Kohorte 2 (Erstlinientherapie bei älteren AML-Patienten):
    • Patienten mit ≥65 Jahren mit unbehandelter AML, die für eine Standardinduktionstherapie nicht in Frage kommen oder diese verweigern
    Allgemeine Einschlusskriterien:
    • Alter ≥18 Jahre
    • ECOG Performance Status ≤2
    • Adäquate Organfunktion:
    – Gesamtbilirubin ≤2 x ULN (≤3 × ULN, falls durch leukämische Infiltration oder M. Meulengracht bedingt)
    – AST und ALT ≤2.5 × ULN (≤5.0 × ULN falls durch leukämische Infiltration bedingt)
    – Serumkreatinin ≤2 × ULN oder glomeruläre Filtrationsrate (GFR) ≥50 mL/h
    • Adäquate Herzfunktion: TTE mit dokumentierter LVEF ≥50% innerhalb von sechs Monaten vor erster Studienmedikations-Gabe
    • Zeitabstand zur Vortherapie von mindestens zwei Wochen ODER mindestens 5 Halbwertszeiten
    • GvHD Grad ≤A unter Therapie mit ≤10 mg Prednison ohne weitere Immunsuppression (Tacrolimus, Ciclosporin, etc.)
    • Schriftliches Einverständnis
    • Negativer Schwangerschaftstest und adäquate Kontrazeptionsmethode für weibliche Studienteilnehmer in gebärfähigem Alter, adäquate Kontrazeptionsmethode für männliche Studienteilnehmer
    E.4Principal exclusion criteria
    • Patients with APL.
    • Patients with known allergy or hypersensitivity to nivolumab, 5-azacytidine, relatlimab, or any
    of their components.
    • Patients with a history of life-threatening toxicity related to prior immune therapy (e.g. anti- CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (e.g., hormone replacement after endocrinopathy).
    • Patients who have previously been treated with immunotherapeutic drugs targeting PD-1/PD-L1 in combination with 5-azacytidine.
    • Patients who have previously been treated with LAG-3 targeted agents.
    • Patients with a known history of severe interstitial lung disease or severe pneumonitis.
    • Patients with an active, known or suspected history of any autoimmune disease
    • Akute Promyelozytenleukemie (APL)
    • Biphänotypische oder bilineare Leukämie
    • Bekannte Allergie oder Unverträglichkeit gegen 5- Azacitidine, Nivolumab, Relatlimab, oder einen ihrer Bestandteile
    • Anamnestisch vorbekannte lebensgefährliche Nebenwirkung in Zusammenhang mit einer vorhergegangenen Immuntherapie
    • Vorhergegangene Therapie mit Immuntherapeutika gegen OD-1/PD-L1 in Kombination mit 5-Azacitidine
    • Vorhergegangene Therapie mit Medikamenten, die gegen LAG-3 gerichtet sind
    Anamnestisch vorbekannte schwere interstitielle Lungenerkrankung oder schwere Pneumonitis
    • Anamnestisch (aktive, vorbekannte oder vermutete) Vorerkrankung einer der folgenden Autoimmunerkrankungen:
    – Chronisch-entzündliche Darmerkrankung
    – Rheumatoide Arthritis
    – Progressive systemische Sklerose
    – Systemischer Lupus erythematodes
    – Autoimmunvaskulitis
    • Aktive
    • Aktive
    unkontrollierte Pneumonitis unkontrollierte Infektion
    • Symptomatischer oder unzureichend kontrollierter
    leukämischer ZNS-Befall
    • Anamnestisch vorbekannte Encephalitis, Meningitis oder unkontrolliertes Krampfleiden im Jahr vor Einwilligung zur Studienteilnahme
    • Unkontrollierte oder signifikante kardiovaskuläre V orerkrankung
    • Troponin T (TnT) oder I (TnI) > 2 × institutionelle ULN
    • Z.n. Organtransplantation
    • Allgene hämatopoetische Stammzelltransplantation innerhalb der letzten 100 Tage vor Erstgabe der Studienmedikation
    • aktive GvHD > Grad A
    • Vorbekannte Seropositivität für Humanes Immundefizienz-
    Virus (HIV)
    • Anamnestisch vorbekannte Positivität für Hepatitis B mit nachweisbarem HBs-Antigen oder aktive Hepatitis C- Infektion
    • Anderer medizinischer, psychologischer oder sozialer Zustand, der mit der Studienteilnahme oder Compliance interferieren, oder die Patientensicherheit gefährden könnte
    • Patienten, die nicht bereit oder in der Lage sind, sich an die Vorgaben des Studienprotokolls zu halten
    Schwangere oder stillende Patientinnen
    • Gefängnisinsassen oder Patienten, die gegen ihren Willen untergebracht sind
    E.5 End points
    E.5.1Primary end point(s)
    Lead-in phase: MTD and DLT of relatlimab in combination with nivolumab and 5-azacytidine in patients with R/R AML
    Expansion phase: ORR to treatment with relatlimab + nivolumab + 5-azacytidine in patients with R/R AML
    Expansion phase: ORR to treatment with relatlimab + nivolumab + 5-azacytidine in older patients (≥65 years) with newly diagnosed AML
    E.5.1.1Timepoint(s) of evaluation of this end point
    Lead-in phase: after completion of 1st cycle of treatment and evaluation of DLTs in 6-12 patients (number of subjects depending on DLT occurrence)
    Expansion phase: after completion of study (30 patients)
    E.5.2Secondary end point(s)
    • To determine the safety of therapy with relatlimab + nivolumab + 5-azacytidine for patients with R/R AML
    • To determine the safety of therapy with relatlimab + nivolumab + 5-azacytidine for older patients with newly diagnosed AML
    • To determine the number of patients with R/R AML who achieve a hematologic improvement (HI) in platelets, hemoglobin, or absolute neutrophil count (ANC) and the number of patients with R/R AML who achieve ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine.
    • To determine the number of older patients with newly diagnosed AML who achieve an HI in platelets, hemoglobin, or ANC and the number of older patients with newly diagnosed AML who achieve ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine.
    • To assess the duration of response, disease-free survival (DFS), and overall survival (OS) of patients with R/R AML treated with relatlimab + nivolumab + 5-azacytidine.
    • To assess the duration of response, DFS, and OS in older patients with newly diagnosed AML treated with relatlimab + nivolumab + 5-azacytidine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after completion of study (30 patients)
    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 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 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.8.3 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 30
    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)
    treatment according to clinical routine, which might include approved agents (e.g. cytarabine), participation in another clinical trial or best supportive care.
    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 Decision2020-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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