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    Summary
    EudraCT Number:2014-004697-41
    Sponsor's Protocol Code Number:GO29664
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-01
    Trial results View 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 number2014-004697-41
    A.3Full title of the trial
    AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ANTI?PD-L1 ANTIBODY (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
    ESTUDIO EN FASE TEMPRANA, MULTICÉNTRICO, ABIERTO, DE LA SEGURIDAD Y FARMACOCINÉTICA DEL ANTICUERPO ANTI-PD-L1 (MPDL3280A) EN PACIENTES PEDIÁTRICOS Y ADULTOS JÓVENES CON TUMORES SÓLIDOS PREVIAMENTE TRATADOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial of Anti-PD-L1 Antibody (MPDL3280A) in Pediatric and Young Adult Patients with Previously Treated Solid Tumors
    Estudio del anticuerpo Anti PD-L1 (MPDL3280A) en pacientes pediátricos y adultos jóvenes son tumores sólidos previamente tratados.
    A.4.1Sponsor's protocol code numberGO29664
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 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 organisationGenentech Inc. c/o F. Hoffmann La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameMPDL3280A-RO5541267-F-03
    D.3.4Pharmaceutical form 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 INNnot yet defined
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    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
    Pediatric solid tumors for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) or intolerable
    Tumores sólidos pediátricos en los que el tratamiento previo resultó ineficaz (es decir, tumor recidivante o resistente) o no tolerable.
    E.1.1.1Medical condition in easily understood language
    Pediatric solid tumors for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) or intolerable
    Tumores sólidos pediátricos en los que el tratamiento previo resultó ineficaz (es decir, tumor recidivante o resistente) o no tolerable.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10047987
    E.1.2Term Wilms' tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10031291
    E.1.2Term Osteosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10075333
    E.1.2Term Soft tissue sarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10015560
    E.1.2Term Ewing's sarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 safety and tolerability of MPDL3280A, focusing on the nature, frequency, and severity of serious and non-serious adverse events, as well as effects on laboratory values, vital signs, or other safety biomarkers
    Evaluar la seguridad y la tolerabilidad de MPDL3280A, basándose en el tipo, la frecuencia y la intensidad de los acontecimientos adversos graves y no graves, y en los efectos sobre los valores analíticos y las constantes vitales.
    E.2.2Secondary objectives of the trial
    To characterize the pharmacokinetics of MPDL3280A; To evaluate the immune response to MPDL3280A based on the incidence of anti-therapeutic antibodies (ATAs); to evaluate the anti-cancer activity of MPDL3280A
    Caracterizar la farmacocinética de MPDL3280A. Evaluar la respuesta inmunitaria frente a MPDL3280A, basándose en la incidencia de anticuerpos antiterapéuticos (AAT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Age at study entry < 30 years
    ?Weight ? 3kg
    ?Histologically or cytologically confirmed solid tumor, for which prior treatment had proven to be ineffective (i.e., relapsed or refractory) or intolerable
    ?Current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
    ?Disease that is measurable or evaluable
    ?Archival tumor tissue block available for submission, or willingness to undergo a core or excisional biopsy prior to enrollment
    ?Lansky Performance Status (patients <16 years old) or Karnofsky Performance Status (patients > 16 years old) > 50
    ?Life expectancy >3 months
    - Edad en el momento de la incorporación al estudio < 30 años.
    - Peso >/=3 kg.
    - Tumor sólido histológica o citológicamente confirmado en el que el tratamiento anterior resultó ineficaz (es decir, tumor recidivante o resistente) o no tolerable.
    - Estado actual de la enfermedad para el que no existe ningún tratamiento curativo conocido ni ningún tratamiento que haya demostrado un aumento de la supervivencia con una calidad de vida aceptable.
    - Enfermedad mensurable o evaluable.
    - Bloque de tejido tumoral de archivo disponibles para su envío, o disposición a someterse a una biopsia con aguja gruesa o escisional antes de la inscripción.
    - Estado funcional de Lansky (pacientes < 16 años) o estado funcional de Karnofsky (pacientes > 16 años) >50.
    - Esperanza de vida > 3 meses
    E.4Principal exclusion criteria
    ?Primary central nervous system (CNS) malignancy, untreated CNS metastases or treated but symptomatic CNS metastases
    ?Prior allogeneic hematopoietic stem-cell transplant or prior solid-organ transplantation
    ?Pregnant or lactating, or intending to become pregnant during the study
    ?Treatment with a live vaccine or a live, attenuated vaccine within 4 weeks prior to initiation of study drug Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibodies
    ?Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to initiation of study drug, or anticipated requirement for systemic immunosuppressive medications during the trial
    ?Current treatment with therapeutic anticoagulants
    ?Known active infection (excluding fungal infection of nail beds) within 28 days prior to initiation of study drug that has not completely resolved
    ?History of autoimmune disease
    ?History of severe asthma or presence of uncontrolled asthma at the time of screening evaluation
    - Neoplasia maligna del SNC conocida, metástasis en el SNC no tratadas, o metástasis en el SNC tratadas pero sintomáticas.
    - Antecedentes de trasplante alogénico de células madre hematopoyéticas o de trasplante de órganos sólidos.
    - Embarazo o lactancia, o intención de quedarse embarazada durante el estudio.
    - Tratamiento con una vacuna con microbios vivos o atenuada en las 4 semanas previas al inicio del fármaco del estudio.
    - Tratamiento previo con agonistas de CD137 o inhibidores de los puntos de control inmunitarios, incluidos anticuerpos terapéuticos anti-CTLA4, anti-PD-1 y anti-PD-L1.
    - Tratamiento con corticosteroides sistémicos u otros inmunodepresores sistémicos en las 2 semanas previas al inicio del fármaco del estudio o previsión de que el paciente necesitará inmunodepresores sistémicos durante el estudio.
    - Tratamiento anticoagulante actual con fines terapéuticos.
    - Infección activa conocida (excluyendo infección fúngica del lecho ungueal) en los 28 días previos al inicio del fármaco del estudio, salvo si se ha resuelto completamente.
    - Antecedentes de enfermedades autoinmunes.
    - Antecedentes de asma grave o presencia de asma no controlado en el momento de las evaluaciones de la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability: All adverse events, all serious adverse events
    Pharmacokinetic: PK parameters are to include Cmax (Day 1 Cycle 1) and Cmin.
    Seguridad y la tolerabilidad: todos los acontecimientos adversos, todos los acontecimientos adversos graves. Farmacocinética: Parámetros de farmacocinética deben incluir: Cmax (Día 1 Ciclo 1) y Cmin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK collections are to include at least 2 samples on Day 1 of Cycle 1 (prior to infusion and one 30 minutes after the infusion). Pre -dose trough samples will be taken on Day 1 of cycles Cycles 2, 3, and 8, 12 and 16 (and every 8 cycles thereafter). In addition, a sample will be taken at the end of treatment and at least 90 days after last dose of study drug (washout)
    Obtenciones farmacocinéticas deben incluir al menos 2 muestras en el Día 1 del Ciclo 1 (antes de la infusión y una 30 minutos posteriormente a la infusión). Se obtendrán muestras pre dosis el Día 1 de los Ciclos 2, 3 y 8, 12 y 16 (y cada 8 ciclos después). Además, se obtendrá una muestra al final del tratamiento y al menos 90 días después de la última dosis de tratamiento del estudio (periodo de lavado).
    E.5.2Secondary end point(s)
    Immunogenicity: Anti therapeutic antibodies
    Efficacy: objective response rate and progression-free survival
    Exploratory endpoints for efficacy: Duration of objective response and overall survival
    Other exploratory endpoints: Determination of pharmacodynamic parameters of MPDL3280A, including PD-L1 status evaluation (archival tumor tissue; blood for PD evaluations will be drawn pretreatment and on day 1 of cycles 2, 3, 8, 12, 16 and every subsequent 8th cycle. In addition, blood for PD will be drawn at the time of study drug discontinuation and at least 90 days after the last dose of study drug (washout).
    Inmunogenia: Anticuerpos antiterapéuticos. Eficacia: tasa de respuesta objetiva y supervivencia libre de progresión. Criterios de valoración exploratorios de eficacia: Duración de la respuesta y supervivencia global. Otros criterios de valoración secundarios: Determinación de parámetros farmacodinámicos de MPDL3280A, incluyendo evaluación de la situación de PD-L1 (tejido tumoral de archivo, se obtendrá sangre para evaluación FC pretratamiento y en los días 1 de los ciclos 2, 3, 8, 12, 16 y posteriormente cada 8 ciclos. Además, se obtendrá sangre para FC en el momento de la discontinuación del tratamiento y al menos 90 días después de la última dosis de tratamiento del estudio (periodo de lavado).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Anti therapeutic antibodies - pretreatment, and on Day 1 of Cycles 2,3, and 8 12, 16 and every 8 cycles thereafter. A sample will also be drawn at the end of treatment and after washout.
    ORR and PFS -tumor assessment will be performed every two cycles [6 weeks] for the first 8 cycles; following cycle 8 tumor assessments will be done every 4 cycles.
    Duration of OR and OSS -tumor assessment will be performed every two cycles [6 weeks] for the first 8 cycles; following cycle 8 tumor assessments will be done every 4 cycles.
    Anticuerpos antiterapéuticos: pre tratamiento, y en Día 1 de los Ciclos 2, 3 y 8, 12 y 16 y posteriormente cada 8 ciclos. Se obtendrá también una muestra al final del tratamiento y tras el periodo de lavado.
    TRO y SLP: Se realizarán evaluaciones tumorales cada dos ciclos (6 semanas) en los 8 primeros ciclos; a partir del ciclo 8 las evaluaciones tumorales se realizarán cada 4 ciclos.
    Duración de RO y SG:- Se realizarán evaluaciones tumorales cada dos ciclos (6 semanas) en los 8 primeros ciclos; a partir del ciclo 8 las evaluaciones tumorales se realizarán cada 4 ciclos.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    first in paediatric population
    primero en población pediátrica
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Austria
    Canada
    Denmark
    France
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Spain
    Switzerland
    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
    The end of this study is defined as the date when LPLV occurs, or 5 years after the last patient is enrolled, whichever occurs first.
    El final del estudio se define como la fecha de la UVUP o 5 años después de la inscripción del último paciente, lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 21
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    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)
    A patient will be eligible to receive study drug after the end of the study if all of the
    following conditions are met:
    ? The patient has a life-threatening or severe medical condition and requires
    continued study drug treatment for his or her well-being
    ? There are no appropriate alternative treatments available to the patient
    ? The patient and his or her doctor comply with and satisfy any legal or regulatory
    requirements that apply to them
    Un paciente será apto para recibir el fármaco del estudio después del final del estudio si se dan todas las condiciones siguientes: - El paciente tiene una enfermedad grave o potencialmente mortal y necesita continuar el tratamiento con el fármaco del estudio por su propio bienestar. - No existen otras opciones de tratamiento apropiadas para el paciente. -El paciente o su médico cumplen todos los requisitos legales o sanitarios aplicables.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Innovative Therapies for Children with Cancer (ITCC)
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-06
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