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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-003167-58
    Sponsor's Protocol Code Number:WO29074
    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:2014-04-01
    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 number2013-003167-58
    A.3Full title of the trial
    A PHASE II, RANDOMIZED STUDY OF MPDL3280A ADMINISTERED AS MONOTHERAPY OR IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL
    CARCINOMA.
    ESTUDIO FASE II, ALEATORIZADO DE MPDL3280A ADMINISTRADO COMO MONOTERAPIA O EN COMBINACIÓN CON BEVACIZUMAB FRENTE A SUNITINIB EN PACIENTES CON CARCINOMA AVANZADO DE CÉLULAS RENALES NO TRATADO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the treatment benefits of MPDL32018 used alone and used together with Avastin to Sunitinib. Benefit is being studied in patients who have advanced kidney cancer or kidney cancer which has spread to other parts of the body and has not been treated before.
    Estudio que compara los beneficios del tratamiento de MPDL32018 utilizado solo o junto con Avastin frente Sunitinib. Se está estudiando el beneficio en pacientes que tienen cáncer de riñón avanzado o cáncer de riñón que se ha extendido a otras partes del cuerpo y no se ha tratado antes.
    A.4.1Sponsor's protocol code numberWO29074
    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 organisationF.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.5.6E-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.3.2Product code MPDL3280A-RO5541267
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeMPDL3280A
    D.3.9.3Other descriptive nameRO5541267
    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 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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    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 nameBevacizumab
    D.3.2Product code RO4876646
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameSunitinib
    D.3.2Product code Ro 4632993
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSUNITINIB
    D.3.9.1CAS number 557795-19-4
    D.3.9.2Current sponsor codeRo 4632993
    D.3.9.4EV Substance CodeSUB22321
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 50
    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 RENAL CELL CARCINOMA
    Carcinoma de células renales avanzado
    E.1.1.1Medical condition in easily understood language
    Cancer of the kidney.
    Cáncer de riñón.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10023400
    E.1.2Term Kidney cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of MPDL3280A + bevacizumab and MPLD3280A monotherapy compared with sunitinib as measured by progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) via an independent central radiologic review.
    Determinar la eficacia de MPDL3280A + bevacizumab y la monoterapia de MPLD3280A comparada con sunitinib determinada por la supervivencia libre de progresión (SLP) según los criterios de evaluación de la respuesta en tumores sólidos, versión 1.1. (RECIST v1.1) a través de una revisión radiológica central independiente.
    E.2.2Secondary objectives of the trial
    ? To evaluate the efficacy (PFS) of MPDL3280A + bevacizumab and MPLD3280A monotherapy versus sunitinib in patients with inoperable locally advanced or metastatic RCC who are PD-L1 positive as assessed by PFS per RECIST v1.1
    ? To evaluate the efficacy of MPDL3280A + bevacizumab and MPLD3280A monotherapy versus sunitinib as assessed by PFS, overall response rate (ORR), and duration of response (DOR) per RECIST v1.1
    ? To evaluate the efficacy of MPDL3280A + bevacizumab and MPLD3280A monotherapy versus sunitinib as assessed by overall survival (OS)
    ? Evaluar la eficacia (SLP) de MPDL3280A + bevacizumab y la monoterapia de
    MPLD3280A frente a sunitinib en pacientes con CCR metastásico o localmente avanzado, inoperable, con resultado positivo para PD-L1 de acuerdo con la evaluación de la SLP según los criterios RECIST v1.1.
    ? Evaluar la eficacia de MPDL3280A + bevacizumab y la monoterapia de MPLD3280A comparado con sunitinib de acuerdo con la evaluación de la SLP, tasa de respuesta objetiva (TRO) y duración de la respuesta (DR) según los criterios RECIST v1.1.
    ? Evaluar la eficacia de MPDL3280A + bevacizumab y la monoterapia de MPLD3280A comparado con sunitinib según la evaluación de la supervivencia global (SG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients >/= 18 years of age
    - Unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
    - Measurable disease, as defined by RECIST v1.1
    - Karnofsky performance score >/= 70
    - Adequate hematologic and end-organ function as defined by protocol
    - Women of childbearing potential and male patients must agree to use adequate methods of contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of MPDL3280A or sunitinib
    - Edad >/= 18 años
    -CCR metastásico o avanzado irresecable con componente de histología de células claras y/o componente de histología sarcomatoide que no se ha tratado previamente con ningún medicamento sistémico, incluyendo tratamiento en el contexto adyuvante.
    -Enfermedad medible, definida según los criterios RECIST, v.1.1
    -IK >/=70
    -Función hematológica y del órgano diana adecuadas como se difine en el protocolo.
    -las mujeres con capacidad de procrear y los pacientes varones con parejas con capacidad de procrear deben acordar el uso de métodos anticonceptivos como se define en el protocolo durante el periodo de tratamiento y durante al menos 6 meses después de la última dosis de MPDL3280A o sunitinib.
    E.4Principal exclusion criteria
    - Radiotherapy for RCC within 14 days prior to Cycle 1, Day 1 with the exception of: Single-fraction radiotherapy given for the indication of pain control
    - Known malignancies or metastasis of the brain or spinal cord or leptomeningeal disease
    - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    - Uncontrolled hypercalcemia or symptomatic hypercalcemia
    - Malignancies other than RCC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome
    - Life expectancy of < 12 weeks
    - Pregnant and lactating women
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - History of autoimmune disease (Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study)
    Bevacizumab- and Sunitinib-Specific Exclusions:
    - Inadequately controlled hypertension
    - Prior history of hypertensive crisis or hypertensive encephalopathy
    - Radioterapia para el CCR en los 14 días previos al día 1 del ciclo 1 con la excepción de: Radioterapia de fracción única administrada para controlar el dolor
    - Cánceres o metástasis conocidas en el cerebro o la médula espinal o enfermedad leptomeníngea
    - Derrame pleural no controlado, derrame pericárdico o ascitis que requieran procedimientos recurrentes de drenaje (una vez al mes o con más frecuencia)
    - Hipercalciemia no controlada o hipercalciemia sintomática
    - Otros cánceres distintos de CCR en los 5 años previos al día 1 del ciclo 1, salvo aquellos con un riesgo mínimo de metástasis o muerte, tratados con los resultados curativos esperados
    - Esperanza de vida < 12 semanas
    - Mujeres embarazadas y en período de lactancia
    - Antecedentes de reacciones alérgicas graves, anafilácticas u otras reacciones de hipersensibilidad a anticuerpos quiméricos o humanizados o a proteínas de fusión
    - Antecedentes de enfermedad autoinmunitaria (Los pacientes con antecedentes de hipotiroidismo autoinmunitario en tratamiento con una dosis estable de hormona tiroidea sustitutiva son idóneos para este estudio)
    Exclusiones específicas de bevacizumab y sunitinib:
    - Hipertensión controlada inadecuadamente
    - Antecedentes de crisis hipertensiva o encefalopatía hipertensiva
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival per RECIST v.1.1 via central ICR assessment
    La supervivencia libre de progresión (SLP) según los criterios RECIST v1.1 mediante evaluación central del CRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximately 2.5 years
    aproximadamente 2,5 años
    E.5.2Secondary end point(s)
    - Progression-free survival using investigator assessment per immune-related criteria
    - Overall response rate
    - Duration of response
    - Overall survival
    - Overall response rate in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment
    - La supervivencia libre de progresión utilizando la evaluación del investigador según los criterios relacionados con el sistema inmunitario
    - Tasa de respuesta global
    - Duranción de la respuesta
    - Supervivencia global
    - Tasa de respuesta global en pacientes cuya enfermedad esté progresando en los grupos tratados con sunitinib y la monoterapia de MPDL3280A que posteriormente cambien al tratamiento con MPDL3280A + Avastin
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 2.5 years
    aproximadamente 2,5 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    France
    Italy
    Romania
    Czech Republic
    Germany
    Poland
    Ukraine
    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 the study is defined as the date when the last patient, last visit (LPLV) occurs.
    El fin del estudio se define como la fecha cuando ocurre la última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    F.4.2.2In the whole clinical trial 150
    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)
    The Sponsor does not have any plans to provide MPDL3280A or other study interventions to patients after the conclusion of the study or any earlier patient withdrawal. The Sponsor will evaluate the appropriateness of continuing to provide MPDL3280A to study patients after evaluating the primary efficacy outcome measure and safety data
    gathered in the study; these analyses may be conducted prior to completion of the study.
    El promotor no tiene planeado proporcionar MPDL3280A u otros estudios intervencionales a los pacientes después de la finalización del estudio o cualquier retirada prematura del paciente. El promotor evaluará la idoneidad de continuar suministrando MPDL3280A a los pacientes del estudio despues de evaluar la medida del resultado de la variable primaria de eficacia y los datos de seguridad
    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 Decision2014-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-08
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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
    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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