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    Summary
    EudraCT Number:2014-003625-17
    Sponsor's Protocol Code Number:CA209-275
    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:2015-01-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-003625-17
    A.3Full title of the trial
    A phase II single arm clinical trial of nivolumab (BMS-936558) in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent
    Ensayo clínico Fase II, de brazo único, de nivolumab (BMS-936558) en sujetos con cáncer urotelial metastásico o irresecable que han progresado o recidivado tras tratamiento con un agente derivado del platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of nivolumab in participants with metastatic or unresectable bladder cancer
    Ensayo de nivolumab en sujetos con cáncer de vejiga metastásico o irresecable
    A.4.1Sponsor's protocol code numberCA209-275
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1160-7382
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number900 150 160
    B.5.6E-mailclinical.trials@bms.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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS936558
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    metastatic or unresectable urothelial cancer
    Cáncer urotelial metastásico o irresecable
    E.1.1.1Medical condition in easily understood language
    metastatic or unresectable urothelial cancer
    Cáncer urotelial metastásico o irresecable
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10046723
    E.1.2Term Urothelial carcinoma ureter
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10046714
    E.1.2Term Urothelial carcinoma bladder
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10046728
    E.1.2Term Urothelial carcinoma urethra
    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
    The purpose of the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.
    El objetivo de este ensayo es medir el efecto de Nivolumab (BMS 936558) en la reducción del tamaño del tumor en sujetos con cáncer de vejiga metastásico o quirúrgicamente irresecable
    E.2.2Secondary objectives of the trial
    -To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee
    -To evaluate overall survival in subjects as assessed by the investigator
    -To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator
    Evaluar la supervivencia libre de progresión (SLP) en sujetos (usando RECIST 1.1) basándose en las evaluaciones realizadas por un comité ce revisión independiente
    Evaluar la supervivencia global (SG) en sujetos de acuerdo a la evaluación del investigador
    Estimar la tasa de respuesta objetiva (TRO) (usando los RECIST 1.1) en sujetos evaluada por el investigador
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder, urethra, ureter, or renal pelvis.
    b. Measurable disease by CT or MRI
    c. Progression or recurrence after treatment
    i) with at least 1 platinum-containing chemotherapy regimen for metastatic or surgically-unresectable locally advanced urothelial cancer, or
    ii) within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer.
    d)Subjects that have received more than 2 prior lines of chemotherapy must not have liver metastases.
    e) tumor tissue (archived or new biopsy) must be provided for biomarker analysis
    f) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
    Evidencia de carcinoma de células transicionales del urotelio metastásico o quirúrgicamente irresecable que afecte a la vejiga, la uretra, el uréter o la pelvis renal.
    Enfermedad medible mediante TC o RM según los criterios RECIST 1.1.
    Los sujetos deben tener progresión o recurrencia después del tratamiento
    a.con al menos 1 régimen de quimioterapia con platino para cáncer urotelial metastásico o localmente avanzado quirúrgicamente irresecable, o
    b.dentro del plazo de 12 meses después del tratamiento peroperatorio (neo-adyuvante o adyuvante) con platino en el contexto de cistectomía para cáncer urotelial localizado con invasión muscular.
    Los sujetos que han recibido más de 2 líneas previas de quimioterapia no deben tener metástasis hepáticas.
    Debe facilitarse tejido tumoral evaluable (de archivo o de una nueva biopsia) para análisis de biomarcadores
    Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) 0 o 1.
    E.4Principal exclusion criteria
    a) Subjects with active cancer that has spread to the central nervous system
    b)Any serious or uncontrolled medical disorder, that in the opinion of the investigator, may increase the risk
    associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or
    interfere with the interpretation of study results.
    c. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
    d. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    e. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
    f. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
    g.Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.

    Exclusion laboratory criteria:
    -Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or
    hepatitis C antibody (HCV antibody) indicating acute or chronic infection.
    - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    -Sujetos con cáncer activo que se ha extendido al Sistema Nervioso Central
    -Cualquier trastorno médico grave o no controlado que, en opinión del investigador, pueda aumentar el riesgo asociado a la participación en el estudio o la administración del medicamento del estudio, deteriorar la capacidad del sujeto para recibir el tratamiento del protocolo o interferir en la interpretación de los resultados del estudio.
    -Tumor maligno previo activo dentro de los 3 años previos, excepto cánceres curables localmente que se hayan curado aparentemente
    -Sujetos con enfermedad autoinmunitaria activa, conocida o sospechada. Se permite reclutar a sujetos con vitiligo, diabetes mellitus de tipo I, hipotiroidismo residual debido a un problema autoinmunitario que sólo precisa sustitución hormonal, psoriasis que no requiere tratamiento sistémico o problemas que no se espera que recurran en ausencia de un desencadenante externo.
    -Sujetos con un problema que exija tratamiento sistémico con corticosteroides (> 10 mg de prednisona al día o equivalente) u otros medicamentos inmunosupresores dentro de los 14 días previos a la administración del medicamento del estudio. Se permiten esteroides inhalados o tópicos y dosis de reposición suprarrenal > 10 mg al día de prednisona o equivalentes en ausencia de enfermedad autoinmunitaria activa.
    -Tratamiento previo con un anticuerpo anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 o cualquier otro anticuerpo o medicamento dirigido específicamente a las vías de coestimulación de los linfocitos T o el punto de control inmunitario.
    -Tratamiento con cualquier quimioterapia, radioterapia, agentes biológicos para el cáncer o tratamiento en investigación dentro de los 28 días previos a la primera administración del tratamiento del estudio.
    Criterios de exclusión en pruebas de laboratorio
    Prueba positiva para antígeno de superficie del virus de la hepatitis B (AcS VHB) o ácido ribonucleico (ARN) del virus de la hepatitis C o anticuerpo frente al virus de la hepatitis C (anticuerpo VHC) que indique infección aguda o crónica.
    Historia conocida de resultado positivo para virus de la inmunodeficiencia humana (VIH) o síndrome de inmunodeficiencia adquirida (SIDA) conocido
    E.5 End points
    E.5.1Primary end point(s)
    The overall response rate (using RECIST 1.1) to nivolumab (BMS-936558) based on a independent review committee in subjects with metastatic or unresectable bladder cancer
    La tasa de respuesta global TRG ( usando RECIST 1.1) con nivolumab (BMS 936558) basada en la revisión por un comité independiente en sujetos con cancer de vejiga metastásico o irresecable
    E.5.1.1Timepoint(s) of evaluation of this end point
    Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug is discontinued
    8 semanas después de la primera dosis y luego cada 8 semanas en adelante hasta 48 semanas, luego será cada 12 semanas hasta la progresión de la enfermedad o suspensión del tratamiento.
    E.5.2Secondary end point(s)
    -To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee
    -To evaluate overall survival in subjects as assessed by the investigator
    -To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator
    Evaluar la supervivencia libre de progresión (SLP) en sujetos (usando RECIST 1.1) basándose en las evaluaciones realizadas por un comité ce revisión independiente
    Evaluar la supervivencia global (SG) en sujetos de acuerdo a la evaluación del investigador
    Estimar la tasa de respuesta objetiva (TRO) (usando los RECIST 1.1) en sujetos evaluada por el investigador
    E.5.2.1Timepoint(s) of evaluation of this end point
    -For progression free survival: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued.
    -For overall survival: Every 3 months during the survival follow-up phase up to a maximum of 5 years
    -for overall response rate: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued
    Para PFS: 8 semanas después de la primera dosis y luego cada 8 semanas en adelante hasta 48 semanas, luego será cada 12 semanas hasta la progresión de la enfermedad o suspensión del tratamiento.
    Para OS: cada 3 meses durante la fase de seguimiento de la supervivencia hasta un máximo de 5 años.
    Para TRG: 8 semanas después de la primera dosis y luego cada 8 semanas en adelante hasta 48 semanas, luego será cada 12 semanas hasta la progresión de la enfermedad o suspensión del tratamiento.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker Assessments, Outcomes Research Assessments,
    Immunogenicity Assessments
    Evaluaciones de biomarcadores, evaluaciones de resultados en salud, evaluaciones de inmunogenicidad
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Czech Republic
    Finland
    Germany
    Italy
    Japan
    Poland
    Spain
    Sweden
    United States
    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
    The study will end when survival follow-up has concluded.
    El estudio terminará cuando el seguimiento de la supervivencia haya concluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    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: 153
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 153
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 306
    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)
    At study end subjects who continue to demonstrate clinical benefit and tolerating study drug will be eligible to receive it. Study drug will be provided via study extension, rollover study or another mechanism.BMS can terminate access to study drug if:a) marketing application rejected by responsible HA;b) study terminated due to safety concerns;c) subject can obtain medication from a government sponsored or private health program; or d) therapeutic alternatives become available in local market
    Cuando concluya el EC, los sujetos demuestren benef.clín y toleren el mto. podrán recibir el mto. suministrado por BMS, mediante una extensión del EC, un estudio de continuación u otro mecanismo. BMS podrá terminar el acceso al fármaco si a) la solic. de AdC es rechazada por las CAs; b) el estudio termina por seguridad; c) se puede obtener el mto. a través de un programa del estado o un programa de salud privado; o d) aparecen alternat.terapéuticas en el mercado local.
    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 Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-09
    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
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