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    Summary
    EudraCT Number:2017-005108-89
    Sponsor's Protocol Code Number:VHIO17002
    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:2018-10-25
    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 number2017-005108-89
    A.3Full title of the trial
    Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumors.
    Basket of Baskets: estudio multicéntrico, modular, abierto y en fase II para evaluar fármacos dirigidos en poblaciones seleccionadas molecularmente con tumores sólidos avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A modular multi-Basket trial to improve personalized medicine in cancer patients
    Estudio modular multi-cesta para mejorar la medicina personaliza en pacientes con cáncer
    A.4.1Sponsor's protocol code numberVHIO17002
    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 SponsorVall d’Hebron Institute of Oncology (VHIO)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d’Hebron Institute of Oncology (VHIO)
    B.5.2Functional name of contact pointSusana Munoz
    B.5.3 Address:
    B.5.3.1Street AddressCellex Building; Carrer Natzaret, 115-117
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932 543 4508614
    B.5.6E-mailsmunoz@vhio.net
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    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.3.4Pharmaceutical 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.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    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.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
    Subjects with advanced solid tumor
    Sujetos con tumor sólido avanzado
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cancer
    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 10065147
    E.1.2Term Malignant solid tumor
    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
    The primary objective is to evaluate the antitumor activity of each matched therapies in small subject populations as a signal finding study.
    For Module I, the primary objective will be the overall response rate by RECIST 1.1 of atezolizumab in each of the arms of module.
    El objetivo principal es evaluar la actividad antitumoral de cada tratamiento emparejado en poblaciones pequeñas de sujetos como estudio de búsqueda de señales. Específicamente, para el Módulo I, el objetivo principal será la tasa de respuesta general mediante RECIST 1.1 del atezolizumab en cada uno de los grupos del módulo.
    E.2.2Secondary objectives of the trial
    To evaluate the clinical benefit of matching therapies in small patient populations.

    Specific Secondary objective for Module 1:
    To characterize the safety and tolerability of atezolizumab as assessed by the incidence and severity of adverse events.
    Evaluar el beneficio clínico de las terapias combinadas en pequeñas poblaciones de pacientes.

    Objetivo secundario específico para el Módulo 1:
    Caracterizar la seguridad y tolerabilidad de atezolizumab en función de la incidencia y la intensidad de los acontecimientos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A:
    1. Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.
    2. Subjects must have ECOG performance status of 0 or 1.
    3. Subjects must be 18 year-old or older.
    4. Subjects must have measurable disease according to RECIST 1.1.
    5. Subjects must have enough tumor tissue for molecular analysis
    • Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 20 to 28 slides depending on the sample tumor cellularity. If there is not enough archival tissue to meet this criterion, the subject must undergo a tumor biopsy.
    • Subjects providing fresh frozen tissue (FFT) must provide 4 core biopsies or equivalent. FFT must be preferentially collected from a tumor biopsy; hence, patients must have disease amenable to be biopsied. Otherwise, the subject should have FFT stored in a biobank or biorepository.
    • Efforts will be made to provide FFT in at least one quarter of the participating subjects. The proportion of subjects that might provide FFT might change based on the results from the molecular analysis.
    • Since some of the tests are performed in FFPE tissue, patients providing FFT from a recent biopsy will have part of the sample processed in FFPE tissue as per Laboratory manual.
    6. Subjects must have adequate hematological function: absolute granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L.
    7. Subject must have adequate renal and hepatic function: creatinine clearance ≥ 30ml/min, serum bilirubin ≤ 1.5 × ULN; unless due to Gilbert’s syndrome, AST/ALT ≤ 5 × ULN if liver metastases are present or AST/ALT ≤ 3 × ULN if
    the subject has no liver involvement.
    8. For subjects requiring a tumor biopsy: patients must have adequate coagulation function quick time ≥ 60%
    9. Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumor
    10.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year (when used consistently and correctly) during the treatment period and for at least 5 months after the last dose of atezolizumab, in case of being included in Part B of the study. Please see protocol for more details.
    11.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol
    12. Ability to understand and the willingness to sign a written informed consent document.
    Part B:
    Inclusion criterion 1/2/3/4 from part A
    5. Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumor
    6. Subjects must have adequate hematological function: absolute granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L
    7. Subjects must have adequate renal and hepatic function:
    • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 − age) × (weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL)
    • Serum bilirubin ≤ 1.5 × ULN; with the following exception: subjects with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled
    • AST/ALT ≤ 5 × ULN if liver metastases are present or AST/ALT ≤ 2.5 × ULN if the subject has no liver involvement.
    • Subjects receiving therapeutic anticoagulation (such as low−molecular weight heparin or warfarin) should be on a stable dose
    8. Specific liver function requirement for module 1: subjects with liver or bone metastases: alkaline phosphatase ≤ 5 × ULN
    9. and 10.Women of child-bearing potential and men must agree to use contraception: same as part A.
    11. Ability to understand and the willingness to sign a written informed consent document.
    12. Tumor must harbor the following alterations
    • Arm 1A: BRCA1 or BRCA2 mutations
    • Arm 1B: MLH1, MSH2, MSH6, or PMS2 mutations
    • Arm 1C: tumors with POLE mutation, POLD1 mutation.
    • Arm 1D: hypermutated tumors
    • Subjects will be enrolled in this cohort if their tumors do not harbor any mutation required for arms 1A, 1B, 1C or 1F and their tumor mutational load meet the specified criteria.
    i. High mutational load (>=16 mutation per Megabase as per FoundationOne test).
    ii. Intermediate mutational load (12-<16 mutations per Megabase per FoundationOne test).
    The definition of intermediate mutational load might be adjusted after an Interim analysis based on the available data.
    • Arm 1E: tumors with other mutations in DNA-repair genes.
    • Arm 1F: tumors with amplified PDL1.
    Parte A:
    1. Los sujetos deben tener una neoplasia maligna histológica o citológicamente confirmada que sea metastásica o no resecable, que haya progresado con el tratamiento estándar, que estén recibiendo un tratamiento estándar contra el cáncer pero que no haya disponible un tratamiento posterior aprobado en caso de progresión, que no puedan recibir el tratamiento estándar o para los que no exista tratamiento estándar.
    2. El paciente debe tener un estado funcional ECOG de 0 o 1.
    3. Los sujetos deben tener al menos 18 años de edad.
    4. Los sujetos deben tener una enfermedad medible de acuerdo con RECIST 1.1.
    5. Los sujetos deben tener una cantidad suficiente de tejido tumoral para el análisis molecular.
    • Los sujetos que proporcionen tejido fijado con formol e incluido en parafina (FFIP) deben proporcionar una cantidad mínima de tejido que oscile entre 20 y 28 portaobjetos, dependiendo de la celularidad del tumor de la muestra. Si no hay suficiente tejido de archivo para cumplir este criterio, el paciente se debe someter a una biopsia del tumor.
    • Los sujetos que proporcionen tejido reciente congelado deben proporcionar 4 biopsias con aguja gruesa o equivalente. El tejido reciente congelado se debe recoger preferentemente a partir de una biopsia del tumor; por tanto, los sujetos deben tener una enfermedad que se pueda biopsiar. De lo contrario, el paciente debe tener tejido tumoral congelado reciente conservado en un biobanco o en un biorepositorio.
    • Se hará todo lo posible para proporcionar tejido reciente congelado en al menos una cuarta parte de los sujetos que participen. La proporción de sujetos que pueden proporcionar tejido reciente congelado podría cambiar de acuerdo con los resultados del análisis molecular.
    • Puesto que algunos de los análisis se realizan en tejido FFIP, a los sujetos que proporcionen tejido reciente congelado a partir de una biopsia reciente se les procesará parte de la muestra en tejido fijado con formol e incluido en parafina (FFIP) según el manual del laboratorio.
    6. Los sujetos deben tener una función hematológica adecuada:
    • Cifra absoluta de granulocitos ≥1,5 × 109/l.
    • Cifra de plaquetas ≥100 × 109/l.
    7. El paciente debe tener una función renal y hepática adecuadas:
    • Aclaramiento de creatinina ≥30 ml/min.
    • Bilirrubina en suero ≤1,5 × LSN; a menos que se deba al síndrome de Gilbert.
    • AST/ALT ≤5 × LSN si hay metástasis hepáticas presentes o AST/ALT ≤3 × LSN si el paciente no tiene afectación hepática.
    8. Para los sujetos que requieran una biopsia del tumor: los sujetos deben tener una función de coagulación adecuada
    • Tiempo rápido ≥60 %
    9. Los sujetos deben estar dispuestos a participar en un ensayo clínico con un tratamiento emparejado de acuerdo con el perfil molecular de su tumor.
    10. Para las mujeres en edad fértil: acuerdo de abstinencia (abstenerse de tener relaciones heterosexuales) o utilizar métodos anticonceptivos con una tasa de fallo de <1 % al año (cuando se usa de forma constante y correcta) durante el periodo de tratamiento y durante al menos 5 meses tras la última dosis de atezolizumab, en caso de que se incluyan en la Parte B del estudio.
    11. Para los varones: acuerdo de abstinencia (abstenerse de tener relaciones heterosexuales) o utilizar métodos anticonceptivos con una tasa de fallo de <1 % al año (cuando se usa de forma constante y correcta), durante el periodo de tratamiento y durante al menos 5 meses tras la última dosis de atezolizumab, en caso de que se incluyan en la Parte B del estudio. Los hombres deben abstenerse de donar esperma durante este mismo periodo.
    12. Capacidad de comprender y voluntad de firmar un documento de consentimiento informado por escrito.
    E.4Principal exclusion criteria
    Part A:
    1.Subjects with known brain metastases or leptomeningeal disease
    2.Subjects with spinal cord compression not definitively treated with surgery and/or radiation
    3.Subjects with uncontrolled intercurrent illness
    4.Subjects with inability to swallow tablets or capsules
    5.Subjects with known HIV, hepatitis B or hepatitis C infection
    6.Subjects with known history of malabsorption
    7.Pregnant and lactating women. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to Day 1.
    Part B:
    1.Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to Day 1. This negative test will be valid for Cycle 1 day 1. In subsequent cycles, serum pregnancy test will be performed on day 1 of each cycle, with a +/- 3 day window, and prior to drug administration.
    2.Any approved anticancer therapy within 3 weeks prior to initiation of study treatment. Exception: hormone-replacement therapy or oral contraceptives; alliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1.
    3.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the study
    4.Treatment with an investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer), with the exception of monoclonal antibodies (4 week wash-out period)
    5.Subjects with known unstable brain metastases. Exception: treated brain metastasis which remain stable or responding 6 weeks after completing radiotherapy
    6.Uncontrolled intercurrent illness that would limit compliance with study requirements
    7.Subjects with active hepatitis B (HBV) or hepatitis C (HCV). Subjects with past HBV infection or resolved HBV infection are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
    8.Significant cardiovascular disease within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina.
    Known left ventricular ejection fraction (LVEF) < 40% will be excluded. Known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
    Uncontrolled effusion requiring recurrent drainage procedures; subjects with indwelling catheters are allowed.
    Uncontrolled hypercalcemia (>1.5mmol/L ionized calcium or Ca > 12mg/dL or corrected serum calcium >ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
    9.Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk of relapse at Investigator discretion
    10.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies. Subjects who have received prior treatment with anti−CTLA-4 may be enrolled, provided at least 5 half-lives have elapsed from the last dose of anti-CTLA-4 to the first dose of Atezolizumab and there was no history of severe immune-mediated adverse effects from anti−CTLA-4
    11.Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is longer) prior to Cycle 1, Day 1
    12.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, fusion proteins or any excipient of the experimental product.
    13.History of active autoimmune disease in the last three years (unless exceptions)
    14.Prior allogeneic bone marrow transplantation or prior solid organ transplantation
    15.Evidence of active pneumonitis on screening chest CT scan or history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or organizing pneumonia. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    16.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination can be given during influenza season only but patients must not receive live, attenuated influenza vaccine within 4 weeks prior to Cycle 1, Day 1 or at any time during the study
    17.Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to
    C1D1, or anticipated requirement for systemic immunosuppressive medications during the trial. Exception: provided into the protocol
    18.History of active tuberculosis
    19.Contraindications included in the product information of the drugs used in the study.
    Parte A:
    1. Sujetos con metástasis cerebrales conocidas o enfermedad leptomeníngea
    2. Sujetos con compresión de la médula espinal que no hayan sido tratados definitivamente con cirugía y / o radiación
    3. Sujetos con enfermedad intercurrente no controlada
    4. Sujetos con incapacidad para tragar tabletas o cápsulas
    5. Sujetos con infección conocida por VIH, hepatitis B o hepatitis C
    6. Sujetos con historial conocido de malabsorción
    7. Mujeres embarazadas y lactantes. Las mujeres en edad fértil deben tener una prueba de embarazo en suero negativa dentro de los 14 días previos al Día 1.

    Parte B:
    1. Mujeres embarazadas o lactantes. Las mujeres en edad fértil deben tener una prueba negativa de embarazo en suero dentro de los 14 días previos al Día 1. Esta prueba negativa será válida para el Ciclo 1 día 1. En ciclos posteriores, la prueba de embarazo en suero se realizará el día 1 de cada ciclo, con una ventana de +/- 3 días, y antes de la administración del medicamento.
    2. Cualquier tratamiento anticancer aprobado dentro de las 3 semanas previas al inicio del tratamiento del estudio. Excepción: terapia de reemplazo hormonal o anticonceptivos orales; Radioterapia paliativa para metástasis óseas > 2 semanas antes del Ciclo 1, Día 1.
    3. Procedimiento quirúrgico mayor dentro de los 28 días previos al Ciclo 1, Día 1 o anticipación de la necesidad de un procedimiento quirúrgico importante durante el estudio
    4. Tratamiento con un agente en investigación dentro de las 4 semanas anteriores al ciclo 1, día 1 (o dentro de las cinco semividas del producto en investigación, el que sea mayor), con la excepción de los anticuerpos monoclonales (período de lavado de 4 semanas)
    5. Sujetos con metástasis cerebrales inestables conocidas. Excepción: metástasis cerebrales tratadas que permanecen estables o que responden 6 semanas después de completar la radioterapia
    6. Enfermedad intercurrente no controlada que limitara el cumplimiento de los requisitos del estudio
    7. Sujetos con hepatitis B (VHB) activa o hepatitis C (VHC). Los sujetos con infección pasada por el VHB o infección resuelta del VHB son elegibles. Los sujetos con anticuerpos contra el VHC son elegibles solo si la reacción en cadena de la polimerasa es negativa para el ARN del VHC
    8.Enfermedad cardiovascular significativa dentro de los 3 meses anteriores al Ciclo 1, Día 1, arritmias inestables o angina inestable.
    Se excluirá la fracción de eyección del ventrículo izquierdo (FEVI) conocida <40%. La enfermedad coronaria conocida, la insuficiencia cardíaca congestiva que no cumple los criterios anteriores o la FEVI <50% deben estar en un régimen médico estable que se optimice en la opinión del médico tratante, en consulta con un cardiólogo, si corresponde.
    Derrame incontrolado que requiere procedimientos recurrentes de drenaje; sujetos con catéteres permanentes están permitidos.
    Hipercalcemia no controlada (> 1,5 mmol / L de calcio ionizado o Ca> 12 mg / dL o calcio sérico corregido> LSN) o hipercalcemia sintomática que requiere el uso continuado de la terapia con bifosfonato o denosumab
    9. Otra malignidad primaria que no sea la enfermedad en estudio dentro de los 2 años anteriores al Ciclo 1 Día 1, a menos que se considere de bajo riesgo de recaída a discreción del Investigador
    10. Tratamiento previo con agonistas de CD137 o terapias de bloqueo del punto de control inmune, anticuerpos terapéuticos anti-PD1 o anti-PDL1. Los sujetos que hayan recibido tratamiento previo con anti-CTLA-4 pueden inscribirse, siempre que hayan transcurrido al menos 5 vidas medias desde la última dosis de anti-CTLA-4 hasta la primera dosis de Atezolizumab y no haya antecedentes de inmunodeficiencia grave por efectos adversos mediados por anti-CTLA-4
    11. Tratamiento con agentes inmunoestimulantes sistémicos dentro de las 4 semanas o con cinco semividas del medicamento (el que sea mayor) antes del ciclo 1, día 1
    12.Historia de reacciones alérgicas, anafilácticas u otras reacciones de hipersensibilidad graves a anticuerpos quiméricos o humanizados o proteínas de fusión, proteínas de fusión o cualquier excipiente del producto experimental.
    13. Historia de enfermedad autoinmune activa en los últimos tres años (salvo excepciones)
    14. Trasplante alogénico de médula ósea previo o trasplante de órgano sólido anterior
    15.Evidencia de neumonitis activa en la exploración de tomografía computarizada de tórax o antecedentes de fibrosis pulmonar idiopática, neumonitis inducida por fármacos o neumonía organizada. Se permite un historial de neumonitis por radiación en el campo de radiación (fibrosis).
    Para el resto de criterios de exclusión por favor remitirse al protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    • Overall response rate (ORR) by RECIST 1.1 of different targeted agents in molecularly selected small patient populations.

    Specific Primary Endpoint for Module 1
    • Overall response rate by RECIST 1.1 of atezolizumab in each of the arms of module.
    • Tasa de respuesta global (ORR) por RECIST 1.1 de diferentes agentes dirigidos en pequeñas poblaciones de pacientes seleccionados molecularmente.

    Punto final primario específico para el Módulo 1
    • Tasa de respuesta global por RECIST 1.1 de atezolizumab en cada uno de los brazos del módulo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12
    En la semana 12
    E.5.2Secondary end point(s)
    • Mean progression free survival (PFS by RECIST 1.1) of the patients participating in iBASKET evaluated at the end of the module.
    • Progression Free Survival (PFS by RECIST 1.1) at 6 months of subjects treated with targeted therapy in iBASKET.
    • Mean overall survival of subjects treated with targeted therapy in iBASKETevaluated at the end of the module.

    Specific Secondary Endpoints for Module 1
    • To evaluate the safety of atezolizumab in subjects with recurrent or metastatic solid tumors. Continued evaluation during the trial (Module 1).
    • Supervivencia media libre de progresión (PFS por RECIST 1.1) de los pacientes que participan en iBASKET evaluados al final del módulo.
    • Progression Free Survival (PFS por RECIST 1.1) a los 6 meses de los sujetos tratados con terapia dirigida en iBASKET.
    • La supervivencia media total de los sujetos tratados con terapia dirigida en iBASKET se evalúa al final del módulo.

    Puntos finales secundarios específicos para el Módulo 1
    • Evaluar la seguridad del atezolizumab en sujetos con tumores sólidos recurrentes o metastásicos. Evaluación continua durante el ensayo (Módulo 1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Mean progression free survival at the end of the module.
    - Progression Free Survival at 6 months
    - Mean overall survival at the end of the module
    -Safety, continued evaluation during the trial
    - Supervivencia media libre de progresión al final del módulo.
    - Supervivencia libre de progresión a los 6 meses
    - Supervivencia global media al final del módulo
    -Seguridad, evaluación continua durante el estudio
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    estudio cesta de cesta, estudio modular
    basket of basket study, modular study
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of the module will be considered 6 months after the last dose of the last participant patient in that specific module (after the Follow-up visit) or until all subjects have died, withdrawn consent or are lost to follow-up (whichever occurs first). A subject will be considered lost to follow up when reasonable attempts are made by the site to contact him/her without success.
    El final del módulo se considerará 6 meses después de la última dosis del último paciente participante en ese módulo específico (después de la visita de seguimiento) o hasta que todos los sujetos hayan fallecido, hayan retirado el consentimiento o se haya perdido el seguimiento (lo que ocurra primero ) Se considerará que se ha perdido el seguimiento cuando el centro haya hecho varios intentos para comunicarse con él / ella sin éxito.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    No plans for treatment after the subject has ended the participation in the trial.
    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 Decision2018-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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