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    Summary
    EudraCT Number:2017-003479-78
    Sponsor's Protocol Code Number:SGN22E-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-28
    Trial results View 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 number2017-003479-78
    A.3Full title of the trial
    A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy.
    Studio a braccio singolo, in aperto, multicentrico su enfortumab vedotin (ASG-22CE) per il trattamento di pazienti con tumore uroteliale localmente avanzato o metastatico precedentemente sottoposti a terapia con inibitore del checkpoint immunitario (immune checkpoint inhibitor, CPI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of enfortumab vedotin in patients with locally advanced or metastatic urothelial bladder cancer
    Studio su enfortumab vedotin in pazienti con tumore uroteliale localmente avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberSGN22E-001
    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 SponsorSEATTLE GENETICS, INC.
    B.1.3.4CountryUnited States
    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 supportSeattle Genetics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeattle Genetics Trial Information Support
    B.5.2Functional name of contact pointSeattle Genetics Trial Information
    B.5.3 Address:
    B.5.3.1Street Address21823 30th Drive SE
    B.5.3.2Town/ cityBothell
    B.5.3.3Post codeWA 98021
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018663337436
    B.5.5Fax number000000
    B.5.6E-mailEU-Regulatory@seagen.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 nameEnfortumab vedotin
    D.3.2Product code ASG-22CE
    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 INNENFORTUMAB VEDOTIN
    D.3.9.2Current sponsor codeAGS-22CE
    D.3.9.4EV Substance CodeSUB185524
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Patients with locally advanced or metastatic urothelial cancer.
    Pazienti con tumore uroteliale metastatico o localmente avanzato.
    E.1.1.1Medical condition in easily understood language
    Locally advanced or metastatic urothelial cancer
    Tumore uroteliale metastatico o localmente avanzato
    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 10077056
    E.1.2Term Urothelial carcinoma recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046714
    E.1.2Term Urothelial carcinoma bladder
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046722
    E.1.2Term Urothelial carcinoma bladder stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046726
    E.1.2Term Urothelial carcinoma ureter recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046721
    E.1.2Term Urothelial carcinoma bladder stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046731
    E.1.2Term Urothelial carcinoma urethra recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046723
    E.1.2Term Urothelial carcinoma ureter
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077840
    E.1.2Term Urothelial cancer of renal pelvis
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046715
    E.1.2Term Urothelial carcinoma bladder recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046725
    E.1.2Term Urothelial carcinoma ureter metastatic
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10046730
    E.1.2Term Urothelial carcinoma urethra metastatic
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046728
    E.1.2Term Urothelial carcinoma urethra
    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 determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed ORR in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy with a CPI and either previously received platinum-containing chemotherapy or are platinum-naïve and cisplatin-ineligible
    Determinare l'attivita' antitumorale del singolo agente enfortumab vedotin misurata come conferma ORR in pazienti con carcinoma uroteliale localmente avanzato o metastatico che hanno ricevuto in precedenza una sistemica terapia con un CPI e precedentemente sottoposti a chemioterapia a base di platino oppure naïve al platino e non idonei al cisplatino.
    E.2.2Secondary objectives of the trial
    ¿ To assess DOR
    ¿ To assess disease control rate (DCR)
    ¿ To assess PFS
    ¿ To assess OS
    ¿ To assess the safety and tolerability of enfortumab vedotin
    ¿ To assess the pharmacokinetics (PK) of enfortumab vedotin
    ¿ To assess the incidence of antitherapeutic antibodies (ATA)
    ¿ Valutare DOR
    ¿ Valutare il tasso di controllo della malattia (DCR)
    ¿ Valutare PFS
    ¿ Valutare OS
    ¿ Valutare la sicurezza e la tollerabilit¿ di enfortumab vedotin
    ¿ Valutare la farmacocinetica (PK) di enfortumab vedotin
    ¿ Valutare l'incidenza degli anticorpi anti-terapeutici (ATA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically documented urothelial (previously known as transitional cell) carcinoma (squamous differentiation or mixed cell types allowed).
    • Metastatic disease or locally advanced disease that is not resectable.
    • Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy
    completion are eligible. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
    • Must be one of the following:
    a. Platinum-treated (Cohort 1): Patients who received prior treatment with platinum-containing chemotherapy defined as those who received platinum in the adjuvant/neoadjuvant setting and had recurrent or progressive disease within
    12 months of completion OR received treatment with platinum in the locally advanced (defined as unresectable with curative intent) or metastatic setting;
    OR
    b.Platinum-naïve and cisplatin ineligible (Cohort 2): Patients who have not received prior treatment with platinum-containing or other chemotherapy in the locally advanced or metastatic setting and are ineligible for treatment with cisplatin at time of enrollment due to one of the following: ECOG performance status score of 2; impaired renal function (defined as creatinine clearance
    [CrCl] =30 and <60 mL/min), or a > = Grade 2 hearing loss. Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within12 months of completion will be considered platinum-naïve.
    • Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
    • Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
    • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
    • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of <= 1 for Cohort 1, or <= 2 for Cohort 2.
    • Carcinoma (differenziazione squamosa o tipi di cellule miste consentite) uroteliale documentato istologicamente (noto precedentemente come cellule di transizione)
    • Malattia metastatica o malattia localmente avanzata che non è resecabile.
    • Deve aver ricevuto un trattamento preventivo con un CPI in loco in una impostazione avanzata o metastatica del cancro uroteliale. Sono ammissibili quei pazienti che hanno ricevuto la terapia CPI in ambiente neoadiuvante / adiuvante con una recidiva o progressione della malattia durante la terapia o entro 3 mesi dal completamento della terapia.
    Un CPI è definito come una proteina di morte cellulare programmata 1 (PD-1) o inibitore del ligando di morte programmato 1 (PD-L1).
    • Il paziente deve essere uno dei seguenti:
    Trattamento con platino (Coorte 1): I pazienti sottoposti a un precedente trattamento con chemioterapia a base di platino ovvero coloro che sono stati sottoposti a terapia con platino nel contesto adiuvante/neoadiuvante e che hanno presentato progressione di malattia o malattia ricorrente entro 12 mesi dal completamento O sono stati sottoposti al trattamento con platino nel contesto localmente avanzato (definito come non resecabile con intento curativo) o metastatico;
    O
    b. Naïve al platino e non idonei al cisplatino (Coorte 2): Pazienti non precedentemente sottoposti a chemioterapia a base di platino o altra chemioterapia nel contesto localmente avanzato o metastatico e non idonei al trattamento con cisplatino al momento dell’arruolamento a causa di una delle seguenti condizioni: punteggio di prestazioni ECOG (PS) pari a 2 ,ridotta funzionalità renale (definita come clearance della creatinina >=30 e <60 ml/min), o > = Grado 2. Pazienti sottoposti a platino nel contesto adiuvante/neoadiuvante e senza progressione entro 12 mesi dal completamento saranno considerati naïve al platino.
    • Deve avere un precedente trattamento con il platino-chemioterapia o essere non idoneo per il trattamento con cisplatino al momento dell’arruolamento.
    • Deve aver avuto progressione o una recidiva del cancro uroteliale durante o dopo il ricevimento della terapia più recente.
    • I campioni di tessuto tumorale devono essere disponibili per la presentazione al Promotore prima del trattamento in studio.
    • Deve avere una malattia misurabile in base alla Response Evaluation Criteria in Solid Tumors (RECIST) (Versione 1.1).
    • Status della performance Eastern Cooperative Oncology Group (ECOG) (ECOG) <=1 per Coorte 1 o <= 2 per Coorte 2.
    E.4Principal exclusion criteria
    • Ongoing sensory or motor neuropathy Grade =2.
    • Active central nervous system (CNS) metastases.
    • Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
    • Prior enrollment in an enfortumab vedotin study or prior treatment with monomethyl auristatin E (MMAE)-based antibody-drug
    conjugates (ADCs).
    • Neuropatia motoria o sensoriale in corso Grado =2.
    • metastasi del sistema nervoso centrale attivo (SNC).
    • Miocardite correlata a immunoterapia, colite, uveite o polmonite.
    • Arruolamento precedente in uno studio con enfortumab vedotin o precedente trattamento con monometili coniugati anticorpo-farmaco a base di auristatina E (MMAE) (ADC).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the confirmed Objective Response Rate (ORR) per IRF. The ORR is defined as the proportion of patients with confirmed CR or PR according to RECIST
    Version 1.1 . Patients who do not have at least 2 (initial response and confirmation scan) post-baseline response assessments as described in Section 7.2 of the protocol will be counted as non-responders.
    L'endpoint primario di questo studio è la Objective Response Rate (ORR) per IRF. L'ORR è definito come la proporzione di pazienti con CR o PR confermati secondo RECIST Versione 1.1. Pazienti che non hanno almeno 2 (risposta iniziale e scansione di conferma) valutazioni della risposta post-baseline come descritto in Sezione 7.2 del il protocollo verrà conteggiato come non-rispondenti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to protocol
    In accordo al protocollo
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    - Duration of Response (DOR);
    - Disease Control Rate at Week 16 (DCR16);
    - Progression-free Survival (PFS);
    - Overall Survival (OS);
    -ORR per investigator.
    Gli endpoint secondari chiave sono:
    - Durata della risposta (DOR);
    - Tasso di controllo della malattia alla settimana 16 (DCR16);
    - Sopravvivenza senza progressione (PFS);
    - Sopravvivenza generale (OS);
    -ORR per sperimentatore..
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to protocol
    In accordo al protocollo
    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 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 No
    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.8.2.4Number of treatment arms in the trial1
    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 EEA17
    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
    Japan
    Korea, Republic of
    United States
    France
    Germany
    Italy
    Netherlands
    Spain
    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
    The study will be closed 5 years after enrollment of the last patient, or when no patients remain in long-term follow-up, whichever occurs first.
    Lo studio si concluder¿ 5 anni dopo l'arruolamento dell'ultimo paziente, o quando nessun paziente rimane in follow-up a lungo termine, a seconda di quale caso si verifichi per primo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 No
    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 44
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2018-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-26
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