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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-000587-28
    Sponsor's Protocol Code Number:BGB-A317-306
    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:2019-03-27
    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 number2018-000587-28
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment in Patients with Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.
    Estudio de fase 3, aleatorizado, controlado con placebo y en doble ciego, para evaluar la eficacia y la seguridad de Tislelizumab (BGB-A317) en combinación con quimioterapia como tratamiento de primera línea en pacientes con carcinoma esofágico epidermoide recurrente localmente avanzado o metastásico, no resecable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study compares the effects and safety of Tislelizumab (BGB-A317) plus chemotherapy with placebo (an inactive substance) plus chemotherapy for locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
    Estudio que compara los efectos y la seguridad de Tislelizumab (BGB-A317) más quimioterapia con placebo (una sustancia inactiva) más quimioterapia para carcinoma esofágico epidermoide recurrente localmente avanzado o metastásico.
    A.4.1Sponsor's protocol code numberBGB-A317-306
    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 SponsorBeiGene, Ltd.
    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 supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Ltd.
    B.5.2Functional name of contact pointClinical Trial Information Email
    B.5.3 Address:
    B.5.3.1Street Address2929 Campus Drive, Suite 300
    B.5.3.2Town/ citySan Mateo
    B.5.3.3Post codeCA 94403
    B.5.3.4CountryUnited States
    B.5.4Telephone number----
    B.5.5Fax number----
    B.5.6E-mailclinicaltrials@beigene.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 nameTislelizumab (BGB-A317)
    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 INNTislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
    Carcinoma esofágico epidermoide (ESCC) recurrente localmente avanzado o metastásico, no resecable
    E.1.1.1Medical condition in easily understood language
    Unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
    Carcinoma esofágico epidermoide (ESCC) recurrente localmente avanzado o metastásico, no resecable
    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 10055476
    E.1.2Term Esophageal squamous cell carcinoma
    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 evaluate and compare the PFS assessed per RECIST version (v) 1.1 following treatment with tislelizumab in combination with chemotherapy compared to placebo in combination with chemotherapy when given as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC

    - To evaluate and compare the overall survival (OS) following treatment with tislelizumab in combination with chemotherapy compared to placebo in combination with chemotherapy when given as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC
    -Evaluar y comparar la supervivencia sin progresión (PFS) de acuerdo a los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) versión (v) 1.1, tras el tratamiento con tislelizumab en combinación con quimioterapia, frente a placebo en combinación con quimioterapia, en su administración como tratamiento de primera línea en pacientes con carcinoma esofágico epidermoide (ESCC) recurrente localmente avanzado o metastásico, no resecable.

    -Evaluar y comparar la supervivencia global (OS) tras el tratamiento con tislelizumab en combinación con quimioterapia, frente a placebo en combinación con quimioterapia, en su administración como tratamiento de primera línea en pacientes con ESCC recurrente localmente avanzado o metastásico, no resecable.
    E.2.2Secondary objectives of the trial
    - To evaluate and compare the efficacy of tislelizumab in combination with chemotherapy compared to placebo in combination with chemotherapy as a first-line treatment in unresectable, locally advanced recurrent or metastatic ESCC as measured by ORR and DOR assessed per RECIST v1.1

    - To evaluate and compare Patient Reported Outcomes (PROs) of health-related quality of life (HRQoL) between tislelizumab in combination with chemotherapy compared to placebo in combination with chemotherapy

    - To compare the safety between tislelizumab in combination with chemotherapy and placebo in combination with chemotherapy
    -Evaluar y comparar la eficacia de tislelizumab en combinación con quimioterapia, frente a placebo en combinación con quimioterapia, como tratamiento de primera línea en el ESCC recurrente localmente avanzado o metastásico, no resecable, en su medición mediante la tasa de respuesta objetiva (ORR) y la duración de la respuesta (DOR) según el BIRC de acuerdo a RECIST v1.1.
    -Evaluar y comparar los resultados comunicados por los pacientes (PROs) de la calidad de vida relacionada con la salud (HRQoL) de tislelizumab en combinación con quimioterapia, frente a placebo en combinación con quimioterapia.
    - Comparar la seguridad entre tislelizumab en combinación con quimioterapia, frente a placebo en combinación con quimioterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pathologically (histologically) confirmed diagnosis of ESCC
    • Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease with a treatment free interval of at least 6 months after definitive treatment - Staging by AJCC 7th Edition
    -Diagnóstico de ESCC confirmado anatomopatológicamente (histológicamente).
    -ESCC en Estadio IV, según AJCC 7th Edition (Edge et al 2010), no resecable en el diagnóstico inicial O BIEN enfermedad recurrente localmente avanzada o metastásica, no resecable, con un intervalo sin tratamiento de como mínimo 6 meses si hubiera recibido tratamiento con intención curativa.
    E.4Principal exclusion criteria
    • Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
    • Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
    • Received prior therapies targeting PD-1, PD-L1 or PD-L2
    • Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
    • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
    • Evidence of complete esophageal obstruction not amenable to treatment
    • Unintentional weight loss >=5% within one month prior to randomization or other indicators of severe malnutrition - Severe malnutrition may be determined using the Nutritional Risk Index (Shirasu, et al. 2018)
    • Patients receiving chemotherapy doublet C (platinum and paclitaxel) must not have peripheral neuropathy >=Grade 2 at baseline
    • Patients who recur after definitive surgery and are eligible for non-palliative radiation therapy and/or chemoradiotherapy.
    -Radioterapia paliativa por ESCC en el plazo de las 4 semanas anteriores al inicio del tratamiento del estudio
    -Tratamiento sistémico previo por ESCC no resecable, recurrente localmente avanzado o metastásico
    -Pacientes con evidencia de fístula (esofágica/bronquial o esofágica/aorta)
    -Derrame pleural, pericárdico o ascitis no controlables que precisan drenajes frecuentes o intervención médica (recurrencia clínicamente importante que requiere intervención adicional en el plazo de las 2 semanas siguientes a la intervención)
    -Evidencia de obstrucción esofágica completa no susceptible de tratamiento
    -Recepción de tratamientos previos dirigidos frente a PD-1, PD-L1 o PD-L2
    - Pérdida de peso no intencionada >= 5% en el plazo de 1 mes antes de la aleatorización u otro indicador de desnutrición severa (la desnutrición severa puede determinarse mediante el Nutritional Risk Index, Shirasu, et al. 2018)
    E.5 End points
    E.5.1Primary end point(s)
    PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed per RECIST v1.1 or death, whichever occurs first

    OS - defined as the time from the date of randomization until the date of death due to any cause
    PFS - definida como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de la primera documentación de progresión de la enfermedad por el BIRC de acuerdo a RECIST v1.1 o la muerte, dependiendo de la primera de estas situaciones que tenga lugar
    OS - definida como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de la muerte por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS and OS – analysis will be carried out at approximately 31 months
    PFS y OS – los análisis se llevarán a cabo a los 31 meses aproximadamente
    E.5.2Secondary end point(s)
    - ORR - defined as the proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR)
    - DOR - defined as the time from the first determination of an objective response until the first documentation of progression
    - HRQoL assessment of the patient’s overall health status
    - PFS, ORR, and DOR
    - The incidence and severity of adverse events
    -ORR - definida como el porcentaje de pacientes cuya mejor respuesta global (best overall response, BOR) es respuesta completa (complete response, CR) o respuesta parcial (partial response, PR) según el BIRC de acuerdo a RECIST v1.1
    -DOR - definida como el tiempo transcurrido desde la primera determinación de una respuesta objetiva hasta la primera documentación de progresión de la enfermedad según el BIRC de acuerdo a RECIST v1.1 o la muerte, dependiendo de la primera de estas situaciones que tenga lugar
    -Evaluación de la HRQoL del estado general de salud del paciente mediante el índice europeo EORTC QLQ-C30, el módulo europeo específico para el cáncer de esófago EORTC QLQ-OES18 y el instrumento genérico del estado de salud EuroQol 5D (EQ-5D-5L)
    -PFS, ORR y DOR en su evaluación según el investigador de acuerdo a RECIST v1.1
    -Incidencia y severidad de los acontecimientos adversos (adverse events, AEs) de acuerdo a los National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR - As assessed per RECIST v1.1
    DOR - As assessed per RECIST v1.1 or death, whichever comes first
    HRQoL - European EORTC QLQ-C30 index, the European esophageal cancer specific module EORTC QLQ-OES18, and the generic health state instrument EuroQol 5D (EQ-5D-5L)
    PFS, ORR, and DOR- As assessed by the investigator per RECIST v1.1
    - The incidence and severity of adverse events according to NCI-CTCAE v4.03
    ORR - De acuerdo a RECIST v1.1
    DOR - De acuerdo a RECIST v1.1 o muerte, cualquiera que ocurra antes.
    HRQoL - Indice Europeo QLQ-C30, EORTC QLQ-OES18, EuroQol 5D (EQ-5D-5L)
    PFS, ORR, y DOR- De acuerdo al criterio del investigador por RECIST v1.1
    Incidencia y seriedad de los efectos adversos de acuerdo a NCI-CTCAE v4.03
    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
    Immunogenicity, Tolerability
    Inmunogenicidad, tolerabilidad
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    China
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    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
    LVLS
    Última visita del último paciente
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 312
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 480
    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)
    Patients assigned to tislelizumab, who in the opinion of the Investigator, continue to benefit from tislelizumab at study termination, may be offered the option to continue on treatment in a BeiGene clinical trial until it is commercially available in the country.
    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 Decision2019-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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