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    Summary
    EudraCT Number:2019-000220-18
    Sponsor's Protocol Code Number:SHR-1210-III-310
    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:2019-12-20
    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 number2019-000220-18
    A.3Full title of the trial
    A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib (Rivoceranib) Mesylate Versus Sorafenib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
    Estudio clínico de fase III aleatorizado, abierto, internacional, multicéntrico, del anticuerpo PD-1 SHR-1210 más mesilato de apatinib (Rivoceranib) en comparación con Sorafenib como tratamiento de primera línea en pacientes con carcinoma hepatocelular (CHC) avanzado que no han recibido previamente tratamiento sistémico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate SHR-1210 in Combination With Apatinib (Rivoceranib) as First-Line Therapy in Patients With Advanced HCC
    Un Estudio para evaluar SHR-1210 combinado con Apatinib (Rivoceranib) como tratamiento de primera línea en pacientes con CHC avanzado.
    A.4.1Sponsor's protocol code numberSHR-1210-III-310
    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 SponsorJiangsu Hengrui Medicine Co., Ltd.
    B.1.3.4CountryChina
    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 supportJiangsu Hengrui Medicine Co., Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJiangsu Hengrui Medicine Co., Ltd.
    B.5.2Functional name of contact pointYing Liang
    B.5.3 Address:
    B.5.3.1Street AddressNo. 7 Kunlunshan Road
    B.5.3.2Town/ cityLianyungang
    B.5.3.3Post code222047
    B.5.3.4CountryChina
    B.5.4Telephone number0034957 010 328
    B.5.6E-mailsechepato.hrs.sspa@juntadeandalucia.es
    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 nameCamrelizumab
    D.3.2Product code SHR-1210
    D.3.4Pharmaceutical form Injection
    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 INNCAMRELIZUMAB
    D.3.9.1CAS number 1798286-48-2
    D.3.9.2Current sponsor codeSHR-1210
    D.3.9.4EV Substance CodeSUB188614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    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 nameRivoceranib Mesylate
    D.3.2Product code Rivoceranib Mesylate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRivoceranib mesylate
    D.3.9.3Other descriptive nameAPATINIB MESYLATE
    D.3.9.4EV Substance CodeSUB186421
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namesorafenib tosylate
    D.3.2Product code sorafenib tosylate
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSorafenib
    D.3.9.1CAS number 475207-59-1
    D.3.9.3Other descriptive nameSORAFENIB TOSYLATE
    D.3.9.4EV Substance CodeSUB22347
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    Advanced Hepatocellular Carcinoma (HCC)
    carcinoma hepatocelular (CHC) avanzado
    E.1.1.1Medical condition in easily understood language
    Advanced Hepatocellular Carcinoma (HCC)
    carcinoma hepatocelular (CHC) avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the overall survival (OS) and progression-free survival (PFS) of SHR-1210 plus rivoceranib versus sorafenib
    Comparar la supervivencia general (SG) y la supervivencia sin progresión (SSP) de SHR-1210 combinado con rivoceranib frente a sorafenib
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of SHR-1210 combined with rivoceranib versus sorafenib through evaluations of PFS, time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR).

    • To evaluate the safety of SHR-1210 combined with rivoceranib mesylate versus sorafenib.

    • To evaluate PK of SHR-1210 and rivoceranib and immunogenicity of SHR-1210.
    Comparar la eficacia de SHR-1210 combinado con rivoceranib frente a sorafenib mediante evaluaciones de la SSP, el tiempo hasta la progresión (THP), la tasa de respuesta objetiva (TRO), la tasa de control de la enfermedad (TCE) y la duración de la respuesta (DR).
    •Evaluar la seguridad de SHR-1210 combinado con rivoceranib de mesilato frente a sorafenib
    •Evaluar la farmacocinética (FC) de SHR 1210 y rivoceranib y la inmunogenicidad de SHR-1210
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥ 18 years old, male and female
    - Histopathologically or cytologically confirmed advanced HCC
    - No previous systematic treatment for HCC
    - Have at least one measurable lesion (in accordance with RECIST v1.1)
    - BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
    - ECOG-PS score 0 or 1
    - Child-Pugh Class: Grade A
    - Life Expectancy of at least 12 weeks
    - Subjects with HBV infection: HBV DNA <500 IU/ml or < 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
    - Subjects with HCV-RNA(+) must receive antiviral therapy
    - Adequate organ function
    -Hombre o mujer de ≥18 años.
    - Carcinoma hepatocelular avanzado histológica o citológicamente confirmado.

    -No haber recibido tratamiento sistémico previo para el CHC avanzado.
    -Tener al menos una lesión medible (según los criterios RECIST v1.1,
    -Pacientes en estadio B o C según la clasificación BCLC,y no aptos para someterse a un tratamiento quirúrgico o local, o que hayan experimentado una progresión tras el tratamiento quirúrgico y/o local.
    -Puntuación del EG ECOG:0-1
    -Clase de Child-Pugh grado A.
    -Tener una esperanza de vida ≥12 semanas.
    -Pacientes con infección B (VHB): VHB ADN <500 UI/ml o <2500 y haber recibido un tratamiento contra el VHB durante al menos los 14 días previos a la inscripción en el estudio
    -los pacientes con ácido ribonucleico (ARN) de la hepatitis C (VHC) positivo tendrán que recibir tratamiento antivírico
    -Adecuada función orgánica
    E.4Principal exclusion criteria
    - Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
    - Moderate-to-severe ascites with clinical symptoms
    - History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
    - Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
    - Known genetic or acquired hemorrhage or thrombotic tendency
    - Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
    - Cardiac clinical symptom or disease that is not well controlled
    - Hypertension that can not be well controlled through antihypertensive drugs
    - Factors to affect oral administration
    - History of hepatic encephalopathy
    - Previous or current presence of metastasis to central nervous system
    - HIV infection
    - Combined hepatitis B and hepatitis C co-infection
    - Be ready for or previously received organ or allogenic bone marrow transplantation
    - Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
    - Active known, or suspected autoimmune disease
    - Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
    - Use of potent CYP3A4/CYP2C19 inducers or inhibitors within 14 days prior to the start of study treatment
    - Known history of hypersensitivity to the active substance or to any components of each investigational medicinal product as SHR-1210, rivoceranib , sorafenib or other mAbs
    - Severe infection within 4 weeks prior to the start of study treatment
    - Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
    - Treatment of other investigational product(s) within 28 days or 5 half-lives (whichever comes later) prior to the start of study treatment
    Pacientes con hepatocolangiocarcinoma, CHC sarcomatoide, carcinoma de células mixtas y carcinoma de células laminares conocidos; otros tumores malignos activos, excepto CHC en un plazo de 5 años o de forma simultánea
    Pacientes con ascitis de moderada a grave con síntomas clínicos.
    Pacientes con antecedentes de hemorragia gastrointestinal en el plazo de los 6 meses anteriores al inicio del tratamiento del estudio o clara tendencia a este tipo de hemorragias.
    Pacientes con fístulas abdominales, perforación gastrointestinal o absceso intraperitoneal en los 6 meses previos al inicio del tratamiento del estudio.
    Pacientes con antecedentes conocidos de hemorragia genética o adquirida o tendencia trombótica
    Pacientes con trombosis o acontecimiento tromboembólico en los 6 meses anteriores al inicio del tratamiento del estudio.
    Pacientes con enfermedad o síntoma clínico cardíaco que no está bien controlado .
    Pacientes con hipertensión no controlada que no se puede controlar correctamente con fármacos antihipertensivos .
    Factores que afecten a la administración oral.
    Antecedentes de encefalopatía hepática.
    Antecedentes o presencia actual de metástasis en el sistema nervioso central.
    - Infección por VIH
    - Co-infección combinada de hepatitis B y hepatitis C.
    -Estar listo para recibir o haber recibido previamente un transplante de órgano o transplante alógenico de médula ósea.
    enfermedad pulmonar intersticial sintomática o que pudiera interferir con el juicio y el tratamiento de la toxicidad pulmonar.
    Presencia activa o sospecha de enfermedad autoinmune.
    Pacientes que tomen una medicación con inmunodepresores en los 14 días anteriores al inicio del tratamiento del estudio
    Uso de los inductores fuertes del CYP3A4/CYP2C19 o inhibidores fuertes en los 14 días anteriores al inicio del tratamiento del estudio.
    antecedentes conocidos de hipersensibilidad al principio activo o a cualquiera de los componentes de cada medicamento en investigación como SHR-1210, rivoceranib, sorafenib u otros AcM
    Con infección grave en las 4 semanas anteriores al inicio del tratamiento del estudio
    La radioterapia paliativa para lesiones no diana está permitida para controlar los síntomas, pero debe realizarse al menos 2 semanas antes del inicio del tratamiento del estudio
    Que reciben tratamiento con otros productos en investigación en los 28 días o 5 semividas (lo que suceda más tarde) previos al inicio del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) and PFS
    supervivencia general (SG) y SSP
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the OS endpoint, it will be evaluated from randomization to death from any cause
    For PFS endpoint, it will be evaluated from randomization to the occurrence of disease progression or death from any cause
    Para el criterio de valoración SG, se evaluará desde la aleatorización hasta la muerte por cualquier causa
    Para el criterio de valoración de SSP, se evaluará desde la aleatorización hasta la progresión de la enfermedad o muerte por cualquier causa.
    E.5.2Secondary end point(s)
    • Time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) and PFS
    • Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE v4.03; vital signs, ECG, and abnormal laboratory examinations;
    • Serum concentration of SHR-1210 and plasma concentration of rivoceranib; proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline; analysis of the immunogenicity of SHR-1210 in combination with the concentration of SHR-1210.
    el tiempo hasta la progresión (THP), la tasa de respuesta objetiva (TRO), la tasa de control de la enfermedad (TCE) y la duración de la respuesta (DR) y SSP.
    •Incidencia e intensidad de los acontecimientos adversos (AA) y de los acontecimientos adversos graves (AAG) según los criterios CTCAE del NCI versión 4.03 ; las constantes vitales, los ECG y los valores analíticos anómalos.
    Concentración sérica de SHR-1210 y concentración plasmática de rivoceranib; proporción del anticuerpo anti-SHR-1210 (AAF) y anticuerpo neutralizante (AcN) durante el estudio desde el inicio; análisis de la inmunogenicidad de SHR-1210 en combinación con la concentración de SHR-1210.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR and DCR will be evaluated from randomization until last tumor assessment

    PFS will be evaluated from randomization to the first occurrence of disease progression or death from any cause
    TTP will be evaluated from the date of randomization to the date of the first documented tumor progression
    DOR will be evaluated From the first occurrence of a documented objective response to disease progression or death from any cause
    la TRO, la TCE se evalaurá desde la aleatorización hasta la última evaluación tumoral
    SSP se evalaurá desde la aleatorización hasta la primera progresión de la enfermedad o muerte por cualquier causa
    THP se evaluará desde la fecha de la aleatorización hasta la fecha la primera progresión tumoral documentada.
    DR se evaluará desde la primera respuesta objetiva documentada a la progresión de la enfermedad o a la muerte por cualquier causa
    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 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
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Belgium
    China
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    Turkey
    Ukraine
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 357
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 510
    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)
    Study treatment will continue until the subject develops an intolerable toxicity, withdrawing informed consent or disease progression by BIRC according to RECIST v1.1 is confirmed. If the subject is considered to still have clinical benefit and meet the criteria for treatment beyond the disease progresses, the subject may continue to receive study medication.
    El tratamiento del estudio continuará hasta que el paciente desarrolle una toxicidad intolerable, retiren el consentimiento informado o hasta que se confirme la progresión de la enfermedad por parte del CRIE de acuerdo con RECIST v1.1. Si se considera que el paciente aún tiene beneficios clínicos y cumple con los criterios para el tratamiento más allá del progreso de la enfermedad, el sujeto puede continuar recibiendo la medicación del estudio.
    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 Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-18
    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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