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    Summary
    EudraCT Number:2019-004770-25
    Sponsor's Protocol Code Number:D7310C00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-28
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-004770-25
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination with Cetuximab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
    Międzynarodowe, randomizowane, prowadzone metodą podwójnie ślepej próby, wieloośrodkowe badanie fazy III, oceniające terapię monalizumabem lub placebo w skojarzeniu z cetuksymabem u pacjentów z nawrotowym lub przerzutowym rakiem płaskonabłonkowym regionu głowy i szyi uprzednio leczonych inhibitorem punktu kontrolnego układu odpornościowego
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Monalizumab Given With Cetuximab or Placebo Given with Cetuximab in Patients With Head and Neck Cancer that has come back or spread to other parts of the body
    Badanie terapii monalizumabem podawanym w skojarzeniu z cetuksymabem lub placebo podawanym w skojarzeniu z cetuksymabem prowadzonej u pacjentów z nawracającym lub przerzutowym rakiem okolicy głowy i szyi
    A.3.2Name or abbreviated title of the trial where available
    INTERLINK-1
    INTERLINK-1
    A.4.1Sponsor's protocol code numberD7310C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 nameMonalizumab
    D.3.2Product code IPH2201
    D.3.4Pharmaceutical form Powder for 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 INNMonalizumab
    D.3.9.1CAS number 1228763-95-8
    D.3.9.2Current sponsor codeIPH2201
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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 Cetuximab
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    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 nameCetuximab
    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 INNCetuximab
    D.3.9.1CAS number 205923-56-4
    D.3.9.3Other descriptive nameCetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Yes
    D.2.1.1.1Trade name Cetuximab
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    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 nameCetuximab
    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 INNCetuximab
    D.3.9.1CAS number 205923-56-4
    D.3.9.3Other descriptive nameCetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
    Pacjenci z nawracającym lub przerzutowym rakiem płaskonabłonkowym okolicy głowy i szyi wcześniej leczeni inhibitorem punktu kontrolnego układu odpornościowego
    E.1.1.1Medical condition in easily understood language
    Patients who had received prior immunotherapy treatment for specific type of head and neck cancer that has come back or spread to other parts of the body
    Pacjenci, którzy otrzymywali uprzednio leczenie immunoterapią w odniesieniu do określonego rodzaju raka głowy i szyi, który powrócił lub rozprzestrzenił się na inne części ciała
    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 10067821
    E.1.2Term Head and neck cancer
    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 compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) in terms of overall survival (OS).
    Porównanie wpływu monalizumabu i cetuksymabu (grupa terapeutyczna A) oraz placebo i cetuksymabu (grupa terapeutyczna B) poprzez ocenę ogólnego przeżycia (OS)
    E.2.2Secondary objectives of the trial
    To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by:
    1. assessment of PFS, ORR, DoR;
    2. assessment of disease-related symptoms, functioning and quality of life;
    3. characterization of the association between clinical outcome and protein expression in the tumor;
    4. assessment of safety and tolerability.

    To investigate PK and immunogenicity of monalizumab.
    Porównanie wpływu monalizumabu i cetuksymabu (grupa terapeutyczna A) oraz placebo i cetuksymabu (grupa terapeutyczna B) poprzez:
    1. ocenę czas przeżycia bez progresji choroby (PFS), wskaźnika odpowiedzi obiektywnej (ORR), czasu odpowiedzi (DoR)
    2. ocenę objawów związanych z chorobą, funkcjonowania i jakości życia związanej ze zdrowiem fizycznym (HRQoL)
    3. charakterystykę powiązania wyników klinicznych i ekspresji białek w mikrośrodowisku guza
    4. ocenę bezpieczeństwa i tolerancji
    Ocena farmakokinetyki (PK) i immunogeniczności monalizumabu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are aged 18 years and over
    2. Recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
    3. Received treatment using a PD-(L)1 inhibitor
    4. Prior platinum failure
    5. Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
    6. At least one measurable lesion at baseline that qualifies RECIST 1.1
    7. A fresh or recently acquired tumor tissue for the purpose of biomarker testing
    8. WHO/ECOG PS of 0 or 1
    1. Uczestnik musi być w wieku ≥18 lat
    2. Histologicznie lub cytologicznie potwierdzony R/M SCCHN jamy ustnej, części ustnej gardła, części krtaniowej gardła lub krtani
    3. Konieczność uprzedniego odbycia leczenia z zastosowaniem ogólnoustrojowego inhibitora PD-(L)1
    4. Niepowodzenie uprzedniego leczenia związkami platyny
    5. Wcześniejsze otrzymanie 1 lub 2 schematów ogólnoustrojowego leczenia R/M SCCHN
    6. Co najmniej jedna zmiana kwalifikująca się jako zmiana mierzalna TL wg kryteriów RECIST 1.1
    7. Dostarczenie świeżej lub ostatnio pozyskanej tkanki guza w celu wykonania badań biomarkerów
    8. Ocena WHO/ECOG PS wynosząca 0 lub 1 w momencie włączenia do badania
    E.4Principal exclusion criteria
    1. Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies
    2. Had prior cetuximab therapy (unless it was administered in curative LA setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
    3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis
    4. Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)
    1. Histologicznie lub cytologicznie potwierdzony rak okolicy głowy i szyi lub umiejscowiony w innej głównej lokalizacji anatomicznej w rejonie głowy i szyi nieokreślony w kryteriach włączenia, w tym uczestnicy z rakiem płaskonabłonkowym o nieznanym ognisku początkowym lub cechach niepłaskonabłonkowych
    2. Uprzednie leczenie cetuksymabem (chyba że stosowane w przypadku lokalnie zaawansowanej choroby w terapii z intencją wyleczenia w skojarzeniu z radioterapią i nie obserwowano progresji choroby przez co najmniej 6 miesięcy po otrzymaniu ostatniej dawki cetuksymabu)
    3. Aktywne lub wcześniej udokumentowane zaburzenia autoimmunologiczne lub zapalne (w tym zapalna choroba jelit (np. zapalenie okrężnicy lub choroba Leśniowskiego-Crohna), zapalenie uchyłków
    4. Równoczesne stosowanie jakiegokolwiek leczenia przeciwnowotworowego. Terapia hormonalna stosowana równocześnie w leczeniu chorób innych niż nowotworowa (np. hormonalna terapia zastępcza) jest dozwolona
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival, defined as the time from the date of randomization until date of death due to any cause.
    Ogólne przeżycie zdefiniowane jako czas od daty randomizacji do daty zgonu z dowolnej przyczyny
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments of survival status must be made periodically from enrollment.
    Ocena statusu przeżycia musi być przeprowadzania okresowo począwszy od włączenia do badania
    E.5.2Secondary end point(s)
    - PFS is defined as time from randomization until disease progression, per RECIST 1.1 as assessed by the investigator at local site or death due to any cause, whichever occurs first.

    - ORR is defined as the proportion of participants with measurable disease who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1.

    - DoR is defined as the time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.

    - Patient questionnaires regarding wellbeing and symptom change in baseline scores across visits

    - Concentration of monalizumab in the blood

    - Presence of antibodies to monalizumab in the blood

    - Measurement of specific biomarkers in the tumor sample(s)

    - AEs, vital signs, clinical laboratory results, ECGs
    • PFS definiuje się jako czas od randomizacji do progresji choroby wg kryteriów RECIST 1.1, na podstawie oceny badacza w ośrodku lokalnym, lub do zgonu z dowolnej przyczyny, zależnie od tego, co nastąpi wcześniej.
    • ORR definiuje się jako odsetek pacjentów z mierzalną chorobą, u których potwierdzono CR lub PR, według oceny badacza w lokalnym ośrodku na podstawie kryteriów RECIST 1.1.
    • DoR definiuje się jako czas od daty uzyskania pierwszej udokumentowanej odpowiedzi do daty udokumentowanej progresji choroby lub zgonu w przypadku braku progresji choroby.
    • Kwestionariusze pacjenta dotyczące oceny samopoczucia i objawów zmiany wyników od badania wyjściowego obserwowana podczas wizyty
    • Stężenie monalizumabu we krwi
    • Obecność przeciwciał przeciwko lekowi (ADA) we krwi
    • Ekspresja specyficznych biomarkerów w próbkach guza
    • Zdarzenia niepożądane (AE), parametry życiowe, wyniki badań laboratoryjnych, EKG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Periodically from enrollment
    Okresowo począwszy od włączenia do badania
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Greece
    Italy
    Japan
    Korea, Democratic People's Republic of
    Netherlands
    Peru
    Philippines
    Romania
    Russian Federation
    Spain
    Switzerland
    Taiwan
    United Kingdom
    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
    „LVLS” (Last Visit Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 400
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Caregiver
    opiekun ustawowy
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 256
    F.4.2.2In the whole clinical trial 600
    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 end of treatment with study drug, patients may be managed according to local standard of care or may continue study treatment for as long as receiving benefit.
    Po zakończeniu leczenia badanym lekiem pacjenci mogą być leczeni zgodnie z lokalnymi standardami opieki lub mogą otrzymywać leczenie przewidziane protokołem tak długo, jak długo odnosić będą korzyści z leczenia.
    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 Decision2021-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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