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    Summary
    EudraCT Number:2017-003479-78
    Sponsor's Protocol Code Number:SGN22E-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    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.
    Estudio multicéntrico, de un solo grupo y abierto, de enfortumab vedotin (ASG-22CE) en el tratamiento de pacientes con cáncer urotelial localmente avanzado o metastásico que han recibido previamente inhibidores de los puntos de control (checkpoint inhibitor, CPI) inmunológicos
    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
    Estudio de enfortumab vedotin en pacientes con cáncer urotelial localmente avanzado o metastásico
    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 number+1866 333 7436
    B.5.6E-mailclinicaltrials@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 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 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 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
    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.
    Pacientes con cáncer urotelial localmente avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Locally advanced or metastatic urothelial cancer
    Cáncer urotelial localmente avanzado o metastásico
    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 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 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046728
    E.1.2Term Urothelial carcinoma urethra
    E.1.2System Organ Class 100000004864
    E.1.2 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 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 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 20.0
    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 20.0
    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 20.0
    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 20.0
    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 20.0
    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 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 10046731
    E.1.2Term Urothelial carcinoma urethra recurrent
    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
    Determinar la actividad antitumoral de la monoterapia con enfortumab vedotin, determinada por la tasa de respuestas objetivas (ORR, objective response rate) en pacientes con cáncer urotelial localmente avanzado o metastásico que han recibido previamente inhibidores de los puntos de control.
    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)
    - Determinar la duración de la respuesta (DOR, duration of response)
    - Determinar la tasa de control de la enfermedad (DCR, Disease control rate)
    - Determinar la supervivencia sin progresión (PFS, Progression free survival)
    - Determinar la supervivencia global (OS, overall survival)
    - Determinar la seguridad y la tolerabilidad de enfortumab vedotin
    - Determinar la farmacocinética (PK, pharmacokinetics) de enfortumab vedotin
    - Determinar la incidencia de anticuerpos antitratamiento (ATA, antitherapeutic antibodies) adicionales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically documented transitional cell carcinoma of the urothelium (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. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
    - Must either have prior treatment with platinum-containing chemotherapy or be ineligible for treatment with cisplatin at time of enrollment.
    - 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 0 or 1.
    - Carcinoma de células transicionales del urotelio demostrado histológica o citológicamente (se admiten la diferenciación escamosa o los tipos celulares mixtos).
    - Enfermedad metastásica o localmente avanzada no resecable.
    - El paciente deberá haber recibido tratamiento previo con un CPI por cáncer urotelial localmente avanzado o metastásico. Se define como CPI un inhibidor de la proteína de la muerte celular programada 1 (PD-1) o de su ligando 1 (PD-L1).
    - El paciente deberá haber recibido tratamiento previo con una quimioterapia que incluía un derivado del platino o no ser elegible para tratamiento con cisplatino en el momento de su reclutamiento para el estudio.
    - El paciente deberá haber mostrado progresión o recidiva de su cáncer urotelial durante o después de su tratamiento más reciente.
    - Disponibilidad de muestras de tejido tumoral para su envío al promotor antes del tratamiento del estudio.
    - Enfermedad medible según los Response Evaluation Criteria in Solid Tumors (RECIST) (Versión 1.1).
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1
    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 treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
    - Neuropatía sensitiva o motora actual de Grado >=2.
    - Metástasis activas en sistema nervioso central.
    - Colitis, uveítis o neumonitis por inmunoterapia.
    - Tratamiento previo con enfortumab vedotina u otro conjugado de anticuerpo basado en la monometil auristatina E (MMAE, monomethyl auristatin E)-fármaco (ADC, antibody-drug conjugate).
    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.
    El criterio principal de valoración en este estudio es la tasa de respuesta objetiva (Objective Response Rate, ORR) confirmada por el centro de revisión independiente (IRF), que se define como el porcentaje de pacientes con respuesta completa o respuesta parcial confirmadas según RECIST Versión 1.1. Los pacientes sin como mínimo 2 evaluaciones posbasales de respuesta (respuesta inicial y estudio radiológico de confirmación) en la forma descrita en la Sección 7.2 del protocolo se calificarán como no respondedores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to protocol.
    De acuerdo al protocolo
    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.
    Los criterios secundarios clave de valoración son:
    - Duración de la respuesta (Duration of Response, DOR);
    - Tasa de control de la enfermedad en la Semana 16 (Disease Control Rate at Week 16, DCR16);
    - Supervivencia sin progresión (Progression-free Survival, PFS);
    - Supervivencia global (Overall Survival, (OS);
    - ORR según el investigador.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to protocol.
    De acuerdo al protocolo
    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 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.8.2.4Number 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Spain
    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
    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.
    El estudio se cerrará 5 años después del reclutamiento del último paciente o una vez que ya no haya ningún paciente en seguimiento a largo plazo, eligiéndose la primera de estas situaciones que tenga lugar.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 120
    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
    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 Decision2018-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
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