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    Summary
    EudraCT Number:2018-003354-24
    Sponsor's Protocol Code Number:XL184–312
    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:2019-01-24
    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 number2018-003354-24
    A.3Full title of the trial
    Randomized, Controlled Phase 3 Study of Cabozantinib (XL184)
    in Combination with Atezolizumab versus Sorafenib in Subjects
    with Advanced Hepatocellular Carcinoma Who Have Not Received
    Previous Systemic Anticancer Therapy
    Estudio de fase III aleatorizado y controlado de cabozantinib (XL184) combinado con atezolizumab frente a sorafenib en pacientes con carcinoma hepatocelular avanzado que no han recibido ningún tratamiento antineoplásico sistémico anterior
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy
    Estudio de Cabozantinib en combinación con Atezolizumab frente a Sorafenib en pacientes con CCH que no han recibido anteriormente tratamiento sistémico anticancer
    A.4.1Sponsor's protocol code numberXL184–312
    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 SponsorExelixis, 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 supportExelixis, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationExelixis, Inc.
    B.5.2Functional name of contact pointExelixis Medical Affairs
    B.5.3 Address:
    B.5.3.1Street Address1851 Harbor Bay Parkway
    B.5.3.2Town/ cityAlameda
    B.5.3.3Post codeCA 94502
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888393 5494
    B.5.6E-maildruginfo@exelixis.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 Yes
    D.2.1.1.1Trade name Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 nameCabozantinib 20mg
    D.3.2Product code XL184
    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 INNCABOZANTINIB
    D.3.9.1CAS number 1140909-48-3
    D.3.9.2Current sponsor codeXL184
    D.3.9.3Other descriptive nameXL184
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 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 Yes
    D.2.1.1.1Trade name Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 nameCabozantinib 60mg
    D.3.2Product code XL184
    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 INNCABOZANTINIB
    D.3.9.1CAS number 1140909-48-3
    D.3.9.2Current sponsor codeXL184
    D.3.9.3Other descriptive nameXL184
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 Yes
    D.2.1.1.1Trade name Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameAtezolizumab
    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 INNATEZOLIZUMAB
    D.3.9.3Other descriptive nameRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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: 4
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/364
    D.3 Description of the IMP
    D.3.1Product nameSorafenib
    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 284461-73-0
    D.3.9.4EV Substance CodeSUB23139
    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
    Hepatocellular carcinoma
    Carcinoma hepatocelular
    E.1.1.1Medical condition in easily understood language
    Liver cancer
    Cáncer de hígado
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. An exploratory objective is to evaluate the single-agent activity of cabozantinib in this patient population.
    El objetivo principal de este estudio es evaluar la eficacia de cabozantinib combinado con atezolizumab frente a sorafenib en pacientes con CHC avanzado que no han recibido ningún tratamiento antineoplásico sistémico anterior. Un objetivo exploratorio es evaluar la actividad de cabozantinib como agente único así como su seguridad en esta población de pacientes.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histological or cytological diagnosis of HCC.
    - The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
    - Measurable disease per RECIST 1.1 as determined by the Investigator. Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
    - Child-Pugh Score of A.
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    -Diagnóstico de CHC histológico o citológico.
    -La enfermedad del paciente no es susceptible a un enfoque de tratamiento curativo (como, trasplante, cirugía, ablación) o tratamiento locorregional (como TACE).
    -Enfermedad medible según RECIST 1.1, tal y como lo determine el investigador.
    -Categoría B o C de la clasificación Barcelona Clinic Liver Cancer (BCLC) (Anexo J).
    -Puntuación A de Child-Pugh (Anexo K).
    -Estado funcional del Eastern Cooperative Oncology Group (Grupo Oncológico Cooperativo de la Costa Este, ECOG) de 0 o 1.
    E.4Principal exclusion criteria
    - Fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
    - Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and ICIs. Subjects who have received local intratumoral or arterial chemotherapy are eligible. Subjects who have received any local anticancer therapy within 28 days prior to randomization are ineligible
    - Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization.
    - Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization..
    - Concomitant anticoagulation with oral anticoagulants
    -Carcinoma fibrolamelar, CHC sarcomatoide o colangiocarcinoma hepatocelular mixto.
    -Tratamiento antineoplásico sistémico anterior para CHC avanzado, como, entre otros, quimioterapia, moléculas pequeñas inhibidoras de cinasa e ICI. Son aptos los pacientes que han recibido quimioterapia arterial o intratumoral. Los pacientes que hayan recibido terapia anticancer local en los 28 dias antes a la aleatorización no son elegibles
    -Radioterapia para metástasis óseas en las 2 semanas previas o cualquier otra radioterapia en las 8 semanas previas a la aleatorización.
    -Anticoagulación concomitante con anticoagulantes orales
    E.5 End points
    E.5.1Primary end point(s)
    • Duration of Progression Free Survival (PFS) per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC)
    • Duration of Overall Survival (OS)
    -Duracion de la supervivencia sin progression (SSP): según criterios evaluables de respuesta en tumors sólidos version 1.1 (RECIST 1.1) según el Comité de Radiológico Independiente Enmascarado (BIRC)
    -Duración de la supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Duration of PFS: The primary analysis of PFS is event-driven and will be conducted after at least 241 events have been observed in the first 342 subjects that are randomized (based upon Greenwich Mean Time randomization date/time values) to the experimental (cabozantinib and atezolizumab) arm and control (sorafenib) arm.
    • Duration of OS: The primary analysis of OS is event-driven and will be conducted after at least 346 deaths have been observed in all subjects who are randomized to the experimental (cabozantinib plus atezolizumab) arm and control (sorafenib) arm, regardless of whether any study treatment or the correct study treatment is received.
    -Duración de SSP: Los análisis principales de SSP se basa en los acontecimientos y se llevarán a cabo después de que se hayan observado al menos 241 acontecimientos en los primeros 342 sujetos aleatorizados (según los valores de aleatorización de fecha/hora de Greenwich Mean Time) para el brazo experimental (cabozantinib y atezolizumab) y para el brazo de control (sorafenib)
    -Duración de SG: Los análisis principals de SG se basa en los acontecimientos y se llevarán a cabo después de que se hayan observado al menos 346 muertes en todos los pacientes aleatorizados en el brazo principal (cabozantinib y atezolizumab) y en el brazo de control (sorafenib), independientemente de si se recibe algún tratamiento del studio o el tratamiento de estudio correcto
    E.5.2Secondary end point(s)
    • Objective response rate (ORR) per RECIST 1.1 by BIRC
    Tasa de respuesta objetiva (TRO) por RECIST 1.1 según BIRC
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR is defined as the proportion of subjects for whom the best overall response at the time of data cutoff is a complete response (CR) or partial response (PR) as assessed by the BIRC per RECIST 1.1, which is confirmed by a subsequent visit ≥ 28 days later.
    TRO es definida como la proporción de sujetos para quienes la major respues general en el momento del corte de datos es una respuesta complete (RC) o una respuesta parcial (RP) según lo evaluado por el BIRC por RECIST 1.1, que se confirma en una visita posterior >_28 dias después
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) 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 Yes
    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 trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    China
    Colombia
    Czech Republic
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    Study Completion by Country or by Site: At the time the Maintenance Phase is initiated, the study will be considered complete at sites and in countries where all subjects have completed post-treatment safety follow-up.
    Finalización del Estudio por país o por centro: En el momento en que se inicie la Faase de Mantenimiento, el estudio sera considerado como completado en los centros y en los países donde todos los pacientes hayan completado el seguimiento de seguridad posterior al tratamiento
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 165
    F.4.2.2In the whole clinical trial 640
    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)
    In the Maintenance Phase, subjects will continue to receive study treatment until they meet the protocol-required criteria for treatment discontinuation. Subjects are to undergo periodic safety assessments (including local laboratory tests) and tumor assessments. The nature and frequency of these assessments during the Maintenance phase are to be performed per institutional standard of care and guidance from the sponsor.
    En la Fase de Mantenimiento, los sujetos continuarán recibiendo el tratamiento de estudio hasta que cumplan con los criterios exigidos por el protocol para la interrupción del tratamiento. Los sujetos Deben someterse a evaluaciones de seguridad periódicas (incluídas pruebas de laboratorio locales) y evaluaciones tumorales. La naturaleza y frecuencia de estas evaluaciones durante la Fase de Mantenimiento deben realizarse según el estándar de institucional de atención y las guías del promotor
    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 Decision2019-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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