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    EudraCT Number:2019-001310-42
    Sponsor's Protocol Code Number:BL.13
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-09
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-001310-42
    A.3Full title of the trial
    A randomized phase II trial assessing trimodality therapy with or without adjuvant Durvalumab (MEDI4736) to treat patients with muscle-invasive bladder cáncer
    Estudio fase II aleatorizado para evaluar la terapia trimodal con o sin adyuvancia con durvalumab (MEDI4736) en pacientes con cáncer de vejiga músculo-invasivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trimodality therapy with or without adjuvant Durvalumab to treat patients with bladder cancer
    Terapia trimodal con o sin adyuvancia con durvalumab en pacientes con cáncer de vejiga
    A.4.1Sponsor's protocol code numberBL.13
    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 SponsorCanadian Cancer Trials Group (CCTG)
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca Inc.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Antonio López, 16 - 1A
    B.5.3.2Town/ cityPinto (Madrid)
    B.5.3.3Post code28320
    B.5.4Telephone number34918166804100
    B.5.5Fax number34918169172
    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 nameDURVALUMAB
    D.3.2Product code MEDI4736
    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 INNDURVALUMAB
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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
    Muscle-invasive bladder cancer
    Cáncer de vejiga músculo-invasivo
    E.1.1.1Medical condition in easily understood language
    Bladder cancer
    Cáncer de vejiga
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066753
    E.1.2Term Bladder transitional cell carcinoma stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066754
    E.1.2Term Bladder transitional cell carcinoma stage III
    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 determine whether durvalumab given after standard trimodality therapy improves disease-free survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer
    Determinar si la administración de durvalumab después de la terapia trimodal mejora la supervivencia libre de enfermedad en comparación con solo seguimiento en pacientes con cáncer de vejiga músculo-invasivo estadio T2 o mayor y que sean candidatos para tratamientos para preservar la vejiga.
    E.2.2Secondary objectives of the trial
    - Compare non muscle-invasive bladder cancer recurrence rate (< T2).
    - Comparison of loco-regional control rate (LCR) between study arms at the 12 week visit.
    - Compare overall and bladder intact disease-free survival between study arms.
    - Compare patterns of disease recurrence between study arms.
    - Compare metastasis-free survival between arms.
    - Compare safety between study arms.
    - Compare quality of life between study arms.
    - Compare cost effectiveness and health economics between study arms.
    Comparar la tasa de recurrencia de cáncer de vejiga no musculo-invasivo.
    Comparación de la tasa de control locoregional (TCL) entre los brazos del estudio a la visita de la semana 12.
    Comparar supervivencia global y la supervivencia libre de enfermedad con la vejiga intacta entre los brazos del estudio.
    Comparar patrones de recurrencia de la enfermedad entre los brazos del estudio.
    Comparar la supervivencia libre de metástasis entre los brazos del estudio.
    Comparar la seguridad entre los brazos del estudio.
    Comparar la calidad de vida entre los brazos del estudio.
    Comparar coste/efectividad y gasto sanitario entre ambos brazos del estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologic diagnosis of urothelial carcinoma of the bladder
    2. Stage T2-T4a N0M0 at time of diagnosis (AJCC-TNM version 8
    3. CT scan of the chest/abdomen/pelvis within 8 weeks from enrollment, showing no evidence of metastatic disease
    4. Patients must be ≥ 18 years of age
    5. Patients must have a life expectancy greater than 6 months
    6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix I) and a body weight of > 30kg
    7. Patients must have adequate hematologic reserve
    8. Patients must have an estimated creatinine clearance ≥ 30 ml/min
    9. Patients must have adequate liver function
    10. All patients must have a tumour block from their primary tumour available and consent to release for correlative analyses
    11. Patients have completed prior trimodality therapy (TMT) consisting of surgery, chemotherapy and radiation therapy treatment prior to enrollment on the BL.13 study
    Patients should begin protocol treatment within 42 days after completion of TMT
    12. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires
    13. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
    14. Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
    15. In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment
    16. Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 3 months following treatment.
    Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation
    17. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
    1. Diagnóstico histológico de carcinoma urotelial de vejiga
    2. Estadio T2-T4a N0M0 al momento del diagnóstico (AJCC-TNM versión 8)
    3. Escáner TAC del tórax/abdomen/pelvis en las 8 semanas desde el reclutamiento sin mostrar evidencias de enfermedad metastásica
    4. Los pacientes deben ser ≥ 18 años
    5. Los pacientes deben tener una esperanza de vida superior a 6 meses
    6. Los pacientes deben tener un estado funcional ECOG de 0-2 y un peso corporal de > 30Kg
    7. Los pacientes deben tener una reserva hematológica adecuada
    8. Los pacientes deben tener un aclaramiento de creatinina estimado
    9. Los pacientes deben tener una función hepática adecuada
    10. Todos los pacientes deben disponer de una muestra tumoral de su tumor primario y consentir la utilización
    11. Los pacientes deben haber completado la terapia trimodal (TTM) previa consistente en cirugía, quimioterapia y radioterapia antes del reclutamiento en el estudio
    Los pacientes deben empezar el tratamiento del estudio en los 42 días posteriores a completar la TTM
    12. El paciente debe comprometerse y ser capaz de completar los cuestionarios de calidad de vida
    13. El consentimiento del paciente debe ser obtenido de forma apropiada de acuerdo con los requisitos aplicables locales y regulatorios
    14. Los pacientes deben estar accesibles para el tratamiento y seguimiento
    15. De acuerdo con la política de CCTG, el tratamiento del estudio empezará durante los 2 días laborables posteriores a la inclusión del paciente
    16. Las mujeres u hombres con capacidad de procrear deben comprometerse a usar un anticonceptivo de alta eficacia durante el tratamiento y en los 3 meses siguientes al mismo. Las mujeres con capacidad de quedarse embarazadas deben realizar un test de embarazo que determine la elegibilidad como parte de la evaluación antes del estudio
    17. Los pacientes con cánceres previos o concomitantes cuya historia natural o tratamiento no tiene potencial para interferir en la seguridad o eficacia de la evaluación del tratamiento en investigación, son candidatos para este estudio
    E.4Principal exclusion criteria
    1. Pre-existing medical conditions precluding treatment
    2. Pregnancy or lactating mothers
    3. Received prior therapy with anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137, anti-CTLA-4) antibody
    4. Active or prior documented autoimmune or inflammatory disorders, diverticulitis with the exception of diverticulosis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener síndrome, rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment.
    5. Patients with active or uncontrolled intercurrent illness including, but not limited to:
    • cardiac dysfunction
    • active peptic ulcer disease or gastritis
    • active bleeding diatheses
    • psychiatric illness
    • Tuberculosis
    • HIV virus infection
    • known active hepatitis B infection
    • known active hepatitis C infection
    6. History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction
    7. Current or prior use of immunosuppressive medication within 28 days of study entry
    8. Peripheral neuropathy ≥ grade 2
    9. History of allergic or hypersensitivity reactions to any study drug or their excipients
    10. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥ 470 msec in screening ECG or history of familial long QT syndrome
    11. History of interstitial lung disease
    12. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy
    13. Any condition that does not permit compliance with the protocol
    14. Live attenuated vaccination administered within 30 days prior to randomization.
    1. Condiciones médicas preexistentes que impidan el tratamiento
    2. Madres en periodo de lactancia o mujeres embarazadas
    3. Haber recibido tratamiento previo con un anti-PD-1, anti-PD-L1,anti-PD-L2), anti-CD137 asociado a linfocitos T citotóxicos (CTLA-4) o cualquier otro anticuerpo
    4. Enfermedad inflamatoria o autoinmune activa o previa documentada,lupus eritematoso sistémico, síndrome de sarcoidosis, o síndrome de Wegner, artritis reumatoide, hipofisitis, uveítis, etc., durante los 3 años previos al inicio del tratamiento.
    5. Los pacientes con enfermedad intercurrente activa o no controlada incluyendo, pero no limitado a:
    • Disfunción cardiaca
    • Úlcera péptica activa o gastritis
    • Diatesis activa sangrante
    • Enfermedad psiquiátrica
    • Infección por el virus de la inmunodeficiencia humana HIV
    • Infección activa por hepatitis B
    • Infección por hepatitis C activa
    6. Historial de inmunodeficiencia primaria, trasplante de un órgano alogénico que requiera terapia inmunosupresora y el uso de agentes inmunosupresores en los 28 días desde la aleatorización (están permitidos los corticoides inhalados/intranasales o sistémicos que no excedan los 10 mg/día de prednisona o dosis equivalente de un corticoide alternativo) o historial previo de toxicidad inmunológica grave causada por otra terapia inmune o reacción a la infusión grado 3 o más
    7. Uso actual o previo de medicación inmunosupresora en los 28 días previos a la entrada en el estudio
    8. Neuropatía periférica ≥ grado 2
    9. Historial de reacciones alérgicas o de hipersensibilidad a cualquier fármaco del estudio o sus excipientes.
    10. Intervalo QT medio corregido por el pulso cardiaco usando la fórmula de Fridericia (QTcF) ≥ 470 msec en ECG o historial de síndrome de QT largo familiar.
    11. Historial de enfermedad pulmonar intersticial
    12. Cualquier condición de enfermedad activa en la cual comprometa la seguridad del tratamiento del estudio o impida la posibilidad de que el paciente reciba el tratamiento del estudio
    13. Cualquier condición que no permita cumplimiento con el protocolo
    14. Administración de una vacuna viva atenuada en los 30 días previos a la aleatorización
    E.5 End points
    E.5.1Primary end point(s)
    Disease-free survival
    Supervivencia Libre de Enfermedad
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization to either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause
    Desde la aleatorización hasta recaída (local o a distancia), un nuevo cáncer de vejiga primario o muerte por cualquier causa
    E.5.2Secondary end point(s)
    Locoregional Control Rate (LCR)
    Bladder-intact Disease-Free Survival
    Overall Survival
    Evaluable for Adverse Events
    Evaluable for Quality of Life Assessment
    Evaluable for Economic Analysis
    Tasa de Control de enfermedad Locorregional
    Supervivencia Libre de Enfermedad con vejiga intacta
    Supervivencia Global
    Acontecimientos Adversos
    Evaluación de la Calidad de Vida
    Analisis Económicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Confirmed locoregional complete response at 3 months after randomization
    From the time of enrollment to the time of radical cystectomy.
    From randomization to death from any cause.
    From the time of their first treatment or visit.
    All subjects who have completed the quality of life questionnaires are evaluable for quality of life.
    All Canadian subject who have completed one patient visit will be assessed for cost effectiveness and health economics
    Respuesta completa locorregional confirmada a los 3 meses después de la aleatorización
    Desde el momento de la inclusión hasta el momento de la cistectomía radical.
    De la aleatorización a la muerte por cualquier causa.
    Desde el momento de su primer tratamiento o visita.
    Todos los sujetos que hayan completado los cuestionarios de calidad de vida son evaluables para calidad de vida.
    Todos los sujetos canadienses que hayan completado una visita de un paciente serán evaluados por su rentabilidad y economía de la salud
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    sin tratamiento
    no further treatment
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 138
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 238
    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)
    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 Decision2019-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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