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    Summary
    EudraCT Number:2017-003983-10
    Sponsor's Protocol Code Number:BGB-A317-208
    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:2018-01-26
    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 number2017-003983-10
    A.3Full title of the trial
    A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma
    Estudio en fase II, multicéntrico y abierto, para investigar la eficacia, la seguridad y la farmacocinética del anticuerpo monoclonal anti-PD-1, BGB-A317, en pacientes con carcinoma hepatocelular irresecable tratado anteriormente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study to investigate efficacy, safety and pharmacokinetics of BGB-A317 in patients with inoperable liver cancer
    Estudio en fase II para investigar la eficacia, la seguridad y la farmacocinética de BGB-A317 en pacientes con cáncer de hígado inoperable.
    A.4.1Sponsor's protocol code numberBGB-A317-208
    A.5.4Other Identifiers
    Name:INDNumber:135200
    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., c/o BeiGene USA, 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 supportBeiGene Ltd., c/o BeiGene USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene Ltd., c/o BeiGene USA, Inc.
    B.5.2Functional name of contact pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post code94608
    B.5.3.4CountryUnited States
    B.5.6E-mailBeigeneClinicalSupportUS@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 nameBGB-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 INN-
    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/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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Previously Treated Unresectable Hepatocellular Carcinoma
    carcinoma hepatocelular irresecable tratado anteriormente
    E.1.1.1Medical condition in easily understood language
    Unresectable Hepatocellular Carcinoma is a specific type of Liver cancer that is unable to be removed by surgery.
    El carcinoma hepatocelular irresecable es un tipo específico de cáncer de hígado que no se puede extirpar mediante cirugía.
    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 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    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 the efficacy of BGB-A317 through Independent Review Committee (IRC) assessed objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in previously treated, unresectable hepatocellular carcinoma (HCC)
    Evaluar la eficacia de BGB-A317 a través de la tasa de respuesta objetiva (TRO) evaluada por el Comité de revisión independiente (CRI) según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) Versión (v)1.1 en el carcinoma hepatocelular (CHC) irresecable tratado anteriormente
    E.2.2Secondary objectives of the trial
    * To assess the efficacy of BGB-A317 through duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), and clinical benefit rate (CBR) assessed by IRC and overall survival (OS)
    * To assess efficacy of BGB-A317 through ORR, DOR, PFS, DCR, and CBR assessed by the investigators
    * To further assess the safety and tolerability of BGB-A317 in patients with previously treated unresectable HCC
    * To assess the health-related quality of life (HRQoL) of BGB-A317 in patients with previously treated unresectable HCC
    *Evaluar la eficacia de BGB-A317 mediante la duración de la respuesta (DR), la supervivencia sin progresión (SSP), la tasa de control de la enfermedad (TCE) y la tasa de beneficio clínico (TBC) evaluadas por el CRI y la supervivencia general (SG)
    *Evaluar la eficacia de BGB-A317 a través de la TRO, la DR, la SSP, la TCE y la TBC
    evaluadas por los investigadores
    *Evaluar la seguridad y la tolerabilidad de BGB-A317 en pacientes con CHC irresecable tratado anteriormente
    *Evaluar la calidad de vida relacionada con la salud (CdVRS) de BGB-A317 en pacientes con CHC irresecable tratado anteriormente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed HCC
    2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
    3. Has received at least 1 line of systemic therapy for unresectable HCC Measurable disease
    4. Child-Pugh score A
    5. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
    6. Adequate organ function
    1. CHC confirmado histológicamente
    2. Que se clasifique como enfermedad en estadio C del Barcelona Clinic Liver Cancer (BCLC) o estadio B del BCLC que no es susceptible de tratamiento locorregional o con recidiva después del mismo, y no es susceptible de un enfoque de tratamiento curativo.
    3. Ha recibido al menos 1 línea de tratamiento sistémico para CHC
    irresecable
    4. Se exige también que todos los pacientes pertenezcan a la Clase A de Child-
    Pugh
    5. Que tengan una puntuación ≤ 1 del estado general según el Grupo de Oncología Cooperativo del Este
    6. Función adecuada del órgano
    E.4Principal exclusion criteria
    1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
    2. Prior therapies targeting PD-1 or PD-L1
    3. Has known brain or leptomeningeal metastasis
    4. Tumor thrombus involving main trunk of portal vein or inferior vena cava
    5. Loco-regional therapy to the liver within 4 weeks before enrollment
    6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc
    7. Has received:
    a. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
    b. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
    8. Active autoimmune diseases or history of autoimmune diseases that may relapse.
    9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration
    1. CHC fibrolamelar conocido, CHC sarcomatoide o colangiocarcinoma mixto e histología del CHC
    2. Terapias anteriores dirigidas a PD-1 o PD-L1
    3. Tiene metástasis cerebrales o leptomeníngeas conocidas
    4. Trombo tumoral que afecta al tronco principal de la vena porta o la vena cava inferior
    5. Terapia locorregional para el hígado dentro de las 4 semanas antes de la inclusión
    6. Antecedentes médicos de enfermedad pulmonar intersticial, neumonitis no infecciosa o enfermedades sistémicas no controladas, que incluyen diabetes, hipertensión, fibrosis pulmonar, enfermedades pulmonares agudas, etc.
    7. Ha recibido:
    a. Dentro de los 28 días o 5 vidas medias (lo que sea más corto) de la primera administración del medicamento del estudio: cualquier quimioterapia, inmunoterapia (p. Ej., Interleucina, interferón, timoxina) o cualquier terapia de investigación
    segundo. Dentro de los 14 días posteriores a la primera administración del medicamento del estudio: sorafenib, regorafenib o cualquier medicamento herbario chino o medicamentos de patente china utilizados para controlar el cáncer
    8. Enfermedades autoinmunes activas o antecedentes de enfermedades autoinmunes que pueden recaer.
    9. Paciente con cualquier condición que requiera tratamiento sistémico con corticosteroides (> 10 mg diarios de prednisona o equivalente) u otra medicación inmunosupresora dentro de los 14 días previos a la administración del medicamento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ORR (complete response [CR] + partial response [PR]) based on RECIST Version 1.1 in patients with previously treated unresectable HCC as evaluated by an IRC
    TRO (respuesta completa [RC] + respuesta parcial [RP]) en función de RECIST v 1.1 en pacientes con CHC irresecable tratado anteriormente según la evaluación de un CRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Per protocol
    por protocolo
    E.5.2Secondary end point(s)
    * DOR, PFS, DCR and CBR assessed by IRC, and OS
    * ORR, DOR. PFS, DCR and CBR assessed by Investigators
    * Safety and tolerability assessment of adverse events (AEs), serious adverse events (SAEs), physical examination, vital signs, electrocardiogram (ECG), and laboratory measurements
    * HRQoL measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC18) index score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) index-score, and the 5-level version of the European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
    *DR, SSP, TCE y TBC evaluadas por el CRI, y SG
    *TRO, DR. SSP, TCE y TBC evaluadas por los investigadores
    *Evaluación de la seguridad y la tolerabilidad de los acontecimientos adversos (AA), acontecimientos adversos graves (AAG), exploración física, constantes vitales, electrocardiograma (ECG) y pruebas analíticas
    *CdVRS medida mediante la puntuación del índice de 18 preguntas sobre el carcinoma hepatocelular de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ HCC18), puntuación del índice de la escala básica de 30 elementos del Cuestionario de Calidad de vida de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-C30), y la versión de 5 niveles del cuestionario europeo de calidad de vida de 5 dimensiones (EQ-5D-5L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    per protocol
    por 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    China
    France
    Germany
    Italy
    Poland
    Spain
    Taiwan
    United Kingdom
    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
    Study termination is defined as the time point when data collection for the patient will stop. The study will continue until the last patient has died, becomes lost to follow up, or withdraws from study, or until sponsor decides to terminate the study.
    La terminación del estudio se define como el momento en que se detiene la recopilación de datos del paciente. El estudio continuará hasta que el último paciente haya muerto, discontinue durante el seguimiento, o se retire del estudio, o hasta que el patrocinador decida finalizar el estudio.
    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 months9
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days17
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 228
    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)
    Patient assigned to BGB-A317, who is in the opinion of the Investigator, continue to benefit from BGB-A317 at study termination, may continue treatment after discussion and agreement by the Sponsor. For these patients, BGB-A317 will be provided by the Sponsor until they can be transitioned to commercial supply.
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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