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    Summary
    EudraCT Number:2019-004895-21
    Sponsor's Protocol Code Number:WO42017
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004895-21
    A.3Full title of the trial
    A PHASE II, SAFETY, AND EFFICACY STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB AND ATEZOLIZUMAB MONOTHERAPY IN PATIENTS WITH METASTATIC AND/OR RECURRENT PD-L1-POSITIVE CERVICAL CANCER.
    STUDIO DI FASE II VOLTO A VALUTARE LA SICUREZZA E L’EFFICACIA DI TIRAGOLUMAB IN ASSOCIAZIONE AD ATEZOLIZUMAB E ATEZOLIZUMAB IN MONOTERAPIA NEL TRATTAMENTO DEL CARCINOMA CERVICALE PD-L1-POSITIVO METASTATICO E/O RECIDIVANTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Tiragolumab plus Atezolizumab and Atezolizumab Monotherapy in Patients with Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer.
    Studio con Tiragolumab in associazione ad Atezolizumab e Atezolizumab in monoterapia in pazienti affetti da Carcinoma Cervicale PDL-1 positivo metastatico e/o recidivante.
    A.3.2Name or abbreviated title of the trial where available
    SKYSCRAPER-04
    SKYSCRAPER-04
    A.4.1Sponsor's protocol code numberWO42017
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04300647
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasilea
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameTiragolumab
    D.3.2Product code [RO7092284/F03-01]
    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 INNTiragolumab
    D.3.9.1CAS number 1918185-84-8
    D.3.9.2Current sponsor codeRO709-2284
    D.3.9.3Other descriptive nameTIRAGOLUMAB, MTIG7192A, anti-TIGIT, aTIGIT, PRO400402, 4.1D3
    D.3.9.4EV Substance CodeSUB197861
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) 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 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 TECENTRIQ®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH - EU/1/17/1220/001
    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 nameAtezolizumab
    D.3.2Product code [RO5541267]
    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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameATEZOLIZUMAB, MPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic and/or recurrent PD-L1 positive cervical cancer
    Carcinoma cervicale positivo a PD-L1 (PD-L1+) metastatico e/o recidivante
    E.1.1.1Medical condition in easily understood language
    Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors.
    Il carcinoma cervicale è una malattia in cui le cellule della cervice diventano anormali e cominciano a crescere in maniera incontrollata, formando tumori.
    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 10055094
    E.1.2Term Cervix cancer metastatic
    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 evaluate the efficacy of tiragolumab in combination with atezolizumab and of atezolizumab monotherapy based on the objective response rate
    • To evaluate the safety and tolerability of tiragolumab in combination with atezolizumab and of atezolizumab monotherapy.
    • Valutare l’efficacia dell’associazione atezolizumab e tiragolumab e di atezolizumab in monoterapia sulla base del tasso di risposta obiettiva (Objective Response Rate, ORR)
    • Valutare la sicurezza e la tollerabilità dell’associazione atezolizumab e tiragolumab e di atezolizumab in monoterapia
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of tiragolumab in combination with atezolizumab and of atezolizumab based on the duration of response, disease control rate, best clinical response rate, progression-free survival (PFS) and overall survival (OS) after randomization, PFS rate at 6 months, and OS rate at 6 months and 12 months
    • To characterize the pharmacokinetics of tiragolumab and atezolizumab
    • To evaluate the immune response to tiragolumab and atezolizumab
    • Valutare l’efficacia dell’associazione atezolizumab e tiragolumab e di atezolizumab in monoterapia sulla base di: Durata della risposta (DOR), Tasso di controllo della malattia (DCR), Migliore risposta clinica (BCR), Sopravvivenza libera da progressione (PFS) e Sopravvivenza globale (OS) dopo la randomizzazione, tasso di PFS a 6 mesi, e tasso di OS a 6 mesi e a 12 mesi
    • Caratterizzare il profilo farmacocinetico dell’associazione di atezolizumab + tiragolumab
    • Valutare la risposta immunitaria all’associazione atezolizumab e tiragolumab e ad atezolizumab in monoterapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Life expectancy >= 12 weeks
    - Ability to comply with the study protocol
    - Eastern Cooperative Oncology Group Performance Status of 0 or 1
    - Histologically confirmed primary Stage IVB, recurrent, or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after at least 1 line of prior systemic chemotherapy that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
    - Measurable disease
    - Adequate hematologic and end-organ function obtained within 14 days prior to randomization
    - Recovery from the effects of surgery, radiotherapy, or chemoradiotherapy
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period.
    - Età >= 18 anni
    - Aspettativa di vita >= 12 settimane
    - Capacità di rispettare il protocollo dello studio
    - PS secondo ECOG pari a 0 o 1
    - Carcinoma a cellule squamose, carcinoma adenosquamoso o adenocarcinoma della cervice primitivo, recidivante o persistente, confermato all’esame istologico (istologie neuroendocrina, a cellule chiare e sarcome non sono consentite), dopo 1- 2 linee precedente di chemioterapia sistemica, non assoggettabile a trattamento curativo con chemioterapia sistemica, chirurgia e/o radioterapia.
    - Malattia misurabile
    - Adeguata funzionalità ematologica, epatica e renale in base ai seguenti risultati di laboratorio ottenuti nei 14 giorni prima della randomizzazione
    - Ripresa dagli effetti dell’intervento chirurgico, della radioterapia o della chemioradioterapia
    - Nelle pazienti in età fertile: consenso a praticare l’astinenza dai rapporti eterosessuali ad adottare metodi contraccettivi che garantiscano un tasso di insuccesso < 1% all’anno durante il periodo di trattamento.
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding or intending to become pregnant during study
    - Treatment with invest. therapy with therapeutic intent within 28 d prior to random.
    - Planned surgery during the study
    - Current treat. with anti-viral therapy for HBV or HCV
    - Subst. abuse within 12 m prior to screening, in the investigator's judgment
    - Any serious medical condition or abnormality in clinical lab tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
    - Bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
    - History of other malignancy within 5 y prior to screening, except for those with an expected negligible risk for metastases or death after curative treatment
    - Any CNS or brain metastases
    - Spinal cord compress. not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 1 week prior to randomization
    - Leptomeningeal disease
    - Uncontrolled or symptomatic hypercalcemia
    - Known, clinically significant liver disease, including act. viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
    - Active or history of autoimm. disease or imm. def., including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
    - Active tuberculosis
    - Severe infection at the time of randomization
    - Significant cardiovascular disease, such as cardiac disease New York Heart Association Class-II or greater, myocardial infarction, or cerebrovascular accident within 3 m prior to randomization, unstable arrhythmias, or unstable angina
    - Major surgical procedure other than for diagnosis within 28 d prior to randomization or anticipation of need for a major surgical procedure during the study
    - Prior allogeneic bone marrow transplantation or solid organ transplant
    - Any other diseases, metabolic dysfunction, physical examination finding, or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
    - Illnesses or conditions that interfere with the patient’s capacity to understand, follow, and/or comply with study procedures
    - Administration of a live, attenuated vaccine within 4 w before randomization or anticipation that such a live attenuated vaccine will be required during the study
    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic ab
    - Treatment with systemic immunostimulatory agents within 4 w or 5 drug-elimination half-lives prior to randomization
    - Treatment with systemic immunosuppressive medications within 1 w prior to randomization or anticipation of need for systemic immunosuppressive medication during study treatment
    - History of severe allergic anaphylactic reactions to chimeric, fully humanized, or humanized antibodies or fusion proteins
    - Known hypersensitivity to Chin. hamster ovary cell products or to any component of the tiragolumab or atezo formulations.
    - Gravid. o allatt. o intenzione di iniziare una gravid. durante lo studio
    - Tratt. con qualsiasi farmaco sperim. con intento terapeutico nei 28 gg precedenti la random.
    - Procedura chir. in progr. nel corso dello studio
    - Attuale terapia con farmaci antivirali per l’HBV o l’HCV
    - Abuso di sostanze nei 12 mm prec.i lo screening, secondo giudizio dello sperim.
    - Q.siasi grave condizione med. o anomalia negli esami clinici di lab. che, secondo il parere dello sperim., precluda alla paz. di partecipare allo studio e portarlo a termine in sicurezza
    - Idronefrosi bilat. i cui sintomi non possono essere alleviati con il posiz. di stent ureterali o di drenaggio percutaneo
    - Anamnesi positiva per altra neoplasia maligna nei 5 aa precedenti lo screening, fatta eccezione per i casi che presentano un rischio trascurabile di metastasi o decesso dopo tratt. con intento curativo
    - Presenza di metastasi a carico del SNC o cerebrali
    - Compress. del mid. spinale non definitivamente trattata con chir. e/o radiot., o diagnosticata e trattata in prec. senza evidenze di malattia clinicam. stabile per >= 1 settimana prima della random.
    - Malattia leptomeningea
    - Ipercalcemia non controllata o sintomatica
    - Epatopatia nota e clinic. significativa, tra cui epatite virale attiva, alcolica o di altro tipo, cirrosi, epatopatia ereditaria o abuso corrente di alcol
    - Pres. att. di o anamnesi pos. per malattia autoimm. o imm.def., tra cui, a mero titolo es., miastenia grave, miosite, epatite autoimm., lupus eritem. sist., artrite reum., malattia infiamm. intestinale, sindrome da ab antifosfolipidi, granulomatosi di Wegener, sindr. di Sjo¨gren, sindr. di Guillain-Barré o scl. Multipla
    - Infez. cronica att. nota o sospetta da EBV allo screen.
    - Tubercolosi att.
    - Infezione severa al momento della random izzazione
    - Cardiovasculop. significativa, quale mal. cardiaca (di classe II o superiore) secondo i criteri della NYHA, infarto del miocardio o acc. cerebrovascolare nei 3 mm precedenti la random., aritmie inst.o angina inst.
    - Proced. chir. magg., non a scopo diagn., nei 28 gg precedenti la random. o necessità prevista di una proced. chirur. magg. durante lo studio
    - Prec. trapianto allog. di mid. osseo o di organi solidi
    - Q.siasi altra malattia, disf. metabolica, obiettività o referto di lab. che ponga il ragionevole sospetto di una malattia, che rappresenti una controindicaz. all’uso di un farmaco sper., che possa interferire con l’interpretaz. dei risultati o che esponga la paz. ad alto rischio di compl. correlate al tratt.
    - Malattia o cond. med. che interferisca con la capacità della paz. di comprendere, seguire e/o rispettare le proc. previste dallo studio
    - Somm. di un vaccino vivo attenuato nelle 4 sett. precedenti la random. o necessità prevista di somm. un tale vaccino durante lo studio
    - Precedente tratt. con agon. di CD137 o terapie che blocc. i checkpoint immunitari, tra cui ab terapeutici anti-CTLA-4, anti-TIGIT, anti-PD-1 e anti-PD-L1
    - Tratt. con immunostim.sistemici nelle 4 sett. o nelle 5 emivite del farmaco precedenti la random.
    - Tratt. con immunosoppr. sistemici nella sett. precedente la random. o necessità prevista di immunosoppr. sistemici durante il tratt. sperim.
    - Anamnesi positiva per reazioni allergiche o anafilattiche severe agli ab chimerici, compl.umani o umanizz. o alle prot. di fusione
    - Ipersensibilità nota ai prodotti sint. a partire da cellule ovariche di criceto cinese o a qualsiasi componente della formul. di tiragolumab o di atezo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Objective response rate as determined by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    2. Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) and the American Society for Transplantation and Cellular Therapy cytokine release syndrome (CRS) consensus grading scale.
    1. Tasso di risposta obiettiva (ORR), secondo quanto stabilito da un comitato radiologico indipendente (IRC) in funzione dei criteri di valutazione della risposta nei tumori solidi, versione 1.1. (RECIST v1.1).
    2. Incidenza e severità degli eventi avversi, con severità stabilita in base ai criteri comuni di terminologia per gli eventi avversi del National Cancer Institute, versione 5.0 (NCI CTCAE v5.0). L’attribuzione del grado di severità della sindrome da rilascio di citochine (CRS) si baserà inoltre sui criteri definiti dalla consensus conference dell’American Society for Transplantation and Cellular Therapy (ASTCT CRS Consensus Grading).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 36 months
    2. Up to 90 days after the final dose of study treatment or until initiation of another anti-cancer therapy.
    1. Fino a 36 mesi
    2. Fino a 90 giorni dopo l’ultima dose del trattamento in studio o fino all’inizio di un’altra terapia antitumorale
    E.5.2Secondary end point(s)
    1. Duration of Response as determined by the IRC according to RECIST v1.1
    2. Disease control rate as determined by the IRC according to RECIST v1.1
    3. Best clinical response rate and Duration of Response as determined by the investigator
    4. PFS after randomization as determined by the IRC according to RECIST v1.1
    5. PFS rate at 6 months as determined by the IRC according to RECIST v1.1
    6. OS after randomization
    7. OS rate at 6 months and 12 months
    8. Minimum serum concentration (Cmin) of tiragolumab
    9. Maximum serum concentration (Cmax) of tiragolumab
    10. Minimum serum concentration(Cmin) of atezolizumab
    11. Maximum serum concentration (Cmax) of atezolizumab
    12. Prevalence of ADAs at baseline and incidence of ADAs to tiragolumab and to atezolizumab during the study.
    1. Durata della risposta (DOR), valutata dall’IRC in funzione dei criteri RECIST v1.1
    2. Tasso di controllo della malattia (DCR), secondo quanto stabilito dall’IRC in funzione dei criteri RECIST v1.1.
    3. Migliore risposta clinica (BCR) e Durata della risposta (DOR), in funzione della valutazione clinica a cura dello sperimentatore.
    4. PFS dopo la randomizzazione valutata dall’IRC in funzione dei criteri RECIST v1.1
    5. Tasso di PFS a 6 mesi valutata dall’IRC in funzione dei criteri RECIST v1.1
    6. OS dopo la randomizzazione
    7. Tasso di OS a 6 mesi e a 12 mesi
    8. Minima concentrazione sierica (Cmin) di tiragolumab
    9. Massima concentrazione sierica (Cmax) di tiragolumab
    10. Minima concentrazione sierica (Cmin) di atezolizumab
    11. Massima concentrazione sierica (Cmax) di atezolizumab
    12. Prevalenza di anticorpi anti-farmaco (ADA) al basale e incidenza degli ADA diretti contro tiragolumab e contro atezolizumab durante lo studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Up to 36 months
    5. At 6 months
    6. Up to 36 months
    7. At 6 and 12 months
    8-12. Day 1 of Cycle 1-4, 8, 12 and 16 and at treatment discontinuation (TD) visit
    1-4. Fino 36 mesi
    5. A 6 mesi
    6. Fino a 36 mesi
    7. A 6 e 12 mesi
    8-12. Giorno 1 dei Cicli 1-4, 8, 12 e 16 e alla visita di interruzione del trattamento (TD )
    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 Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity and Biomarker
    Tollerabilità, Immunogenicità e Biomarcatori
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Costa Rica
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    Thailand
    United States
    France
    Italy
    Poland
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 160
    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)
    If the Sponsor decided to terminate the study, patients who are still receiving study treatment or undergoing survival follow-up may be enrolled in an extension study. (see the Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf).
    Se lo Sponsor decide di interrompere lo studio, i pazienti che stanno ancora ricevendo il trattamento in studio o si stanno sottoponendo a follow-up di sopravvivenza possono essere arruolati in uno studio di estensione (vedere la Politica globale di Roche sull'accesso continuato al medicinale in fase di sperimentazione, disponibile sul seguente sito: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf).
    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 Decision2020-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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