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    Summary
    EudraCT Number:2015-005471-24
    Sponsor's Protocol Code Number:GINECO-OV236b
    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:2017-10-10
    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 number2015-005471-24
    A.3Full title of the trial
    A randomized, double-blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab
    Estudio aleatorizado, doble ciego y de fase III de atezolizumab frente a placebo en pacientes con recidiva tardía de cáncer epitelial de ovario, de trompa de Falopio o peritoneal tratado con quimioterapia basada en platino y bevacizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of atezolizumab compared to placebo for subjects with late relapse ovarian cancer receiving a treatment with platinum-based chemotherapy and bevacizumab.
    Estudio con atezolizumab comparativo con placebo en sujetos con recaída de cáncer de ovario en tratamiento con quimioterapia de platino y bevacizumab
    A.3.2Name or abbreviated title of the trial where available
    ATALANTE : ATezolizumab and Avastin in LAte recurreNT diseasE
    A.4.1Sponsor's protocol code numberGINECO-OV236b
    A.5.4Other Identifiers
    Name:ENGOT-ov29Number:ENGOT
    Name:GEICO-1707Number:GEICO
    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 SponsorARCAGY-GINECO
    B.1.3.4CountryFrance
    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 supportROCHE
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMFAR Clinical Research
    B.5.2Functional name of contact pointFederico Nepote
    B.5.3 Address:
    B.5.3.1Street AddressC/ Sinfonía, 28-2ªplanta nº 1
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28054
    B.5.3.4CountrySpain
    B.5.4Telephone number+03493434 44 12
    B.5.6E-mailinvestigacion@mfar.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 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 nameAtezolizumab
    D.3.2Product code MPDL3280A
    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 INNAtezolizumab
    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.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 Ro 487-6646
    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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) Yes
    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: 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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCarboplatin
    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 INNCarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 5
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePaclitaxel
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameGemcitabine
    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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 6
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePegylated liposomal doxorubicine
    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 INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have first or second late relapse (platinum-free interval > 6 months)
    Pacientes con cáncer epitelial de ovario (incluidas pacientes con adenocarcinoma peritoneal primario y/o de trompa de Falopio) con primera o segunda recidiva tardía (intervalo sin platino > 6 meses)
    E.1.1.1Medical condition in easily understood language
    Determine the efficacy of atezolizumab in patients receiving a chemotherapy and bevacizumab to treat late relapse of ovarian cancer, fallopian tube or peritoneal cancer.
    Determinar la eficacia de atezolizumab en pacientes que reciben quimioterapia y bevacizumab para tratar la recaída tardía de cáncer de ovario, trompa de falopio o cáncer peritoneal.
    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 PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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
    The primary efficacy outcome measure is investigator determined progression-free survival (PFS1) as assessed using RECIST v1.1
    El criterio de valoración principal es la supervivencia libre de progresión (SLP1) mediante los Criterios de evaluación de la respuesta en tumores sólidos (versión 1.1 de RECIST).
    E.2.2Secondary objectives of the trial
    Determine the efficacy of atezolizumab vs placebo on:
    • Time from randomization to second subsequent therapy or death
    • Health-related Quality of Life and patient reported outcomes as measured by EORTC QLQ-C30 and OV28
    • Long term survival using the cure rate modelling
    • Overall survival
    • Objective Response Rate as assessed by RECIST v1.1 and irRECIST
    • PFS1 as assessed per irRECIST
    • Characterization of CA-125 tumor marker levels and their relation to tumor response and PFS1 as measured by RECISTv 1.1 and irRECIST
    • Time from randomization to first subsequent therapy or death
    • Time from randomization to second progression
    • in the PD-L1-ve and PD-L1 +ve subgroups
    To assess the safety and tolerability of atezolizumab compared to placebo
    To evaluate the impact of treatment and disease on resource use as measured by
    different criteria including EuroQoL 5 Dimension questionnaire
    Determinar la eficacia de atezolizumab vs placebo en:
    • Tiempo desde la randomización hasta la segunda terapia posterior o muerte
    • La calidad de vida relacionada con la salud y los resultados informados del paciente según lo determinado por EORTC QLQ-C30 y OV28
    • Supervivencia a largo plazo utilizando el modelo de tasa de curación
    • Supervivencia general
    • Tasa de Respuesta Objetiva evaluada por RECIST v1.1 e irRECIST
    • PFS1 evaluado por irRECIST
    • Caracterización de los niveles de marcadores tumorales CA-125 y su relación con la respuesta tumoral y PFS1, medida por RECISTv 1.1 e irRECIST
    • Tiempo desde la randomización hasta primera terapia posterior o muerte
    • Tiempo desde la randomización hasta segunda progresión
    • En los subgrupos de PD-L1-vo y PD-L1 +vo
    Evaluar la seguridad y tolerabilidad de atezolizumab vs placebo
    Evaluar el impacto del tratamiento y enfermedad en el uso de recursos según diferentes criterios, incluido el cuestionario EuroQoL de 5 dimensiones
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PD-L1 tumor testing on de novo tumor sample.
    Determinación de PD-L1 en una muestra de un tumor de novo.
    E.3Principal inclusion criteria
    I-1. Female Patients must be ≥18 years of age.
    I-2. Signed informed consent and ability to comply with treatment and follow-up.
    I-3. Patients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma.
    I-4. Patients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample: Cell pellet from pleural effusion, or ascites or lavage are not acceptable.; For core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks for the patient and maximizes the chance to get tumor tissue. In case the core biopsies do not contain significant tumor tissue, patient eligibility should be discussed with the sponsor
    I-5. Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization: a) Criterion for relapse can be according to RECIST v1.1, CA125 (GCIG) or clinical symptoms; b) The interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.
    I-6. Patients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.
    I-7.Availability at the study site of representative FFPE archival tumor sample from surgery during front-line therapy, at best before chemotherapy.
    I-8. Patients must have normal organ and bone marrow function: a) Haemoglobin ≥ 10.0 g/dL. ; b) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; c) Platelet count ≥ 100 x 109/L; d) Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); e) Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN; f) Serum creatinine ≤ 1.5 x institutional ULN; g) Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization; h) Urine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hours urine must demonstrate ≤1 g of protein in 24 hours; i) Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 150mmHg and diastolic BP ≤100mmHg).
    I-9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    I - 1. Pacientes de sexo femenino ≥18 años.
    I - 2. Consentimiento informado firmado y capacidad para cumplir con el tratamiento y el seguimiento.
    I-3. Pacientes con cáncer de ovario epitelial no mucinoso progresivo histológicamente confirmado, adenocarcinoma peritoneal primario y/o adenocarcinoma de la trompa de Falopio.
    I-4. Pacientes con PD-L1 determinado por estratificacion y con biopsia nueva enviada al laboratorio central en forma de muestra fijada en formol e incluida en parafina (FFIP). A) El sedimento celular de derrame pleural, ascitis o lavado no es aceptable; B) En las muestras de biopsia con aguja gruesa deberán obtenerse al menos tres núcleos. Las biopsias se deben obtener de una manera que minimice los riesgos para el paciente y maximice la posibilidad de obtener tejido tumoral. En el caso que el núcleo de las biopsias no contengan una cantidad de tejido tumoral significativo, la elegibilidad del paciente debe ser discutida con el Promotor.
    I-5. Pacientes cuya enfermedad ha experimentado recidiva más de 6 meses después de la última dosis de platino antes de la aleatorización: A) Los criterios de la recidiva pueden corresponderse con los criterios RECIST v1.1, CA-125 (GCIG) o síntomas clínicos; B) En el intervalo entre la última dosis de platino y la inclusión en el estudio no deben administrarse nuevos tratamientos antineoplásicos, salvo el tratamiento de mantenimiento que se permite hasta 21 días antes de la entrada en el estudio.
    I-6. Pacientes con una o dos líneas de quimioterapia anteriores. La última línea de quimioterapia deberá haber incluido el platino.
    I-7. Disponibilidad en el centro del estudio de una muestra tumoral FFIP representativa de la cirugía durante la terapia de primera línea, en el mejor de los casos antes de la quimioterapia.
    I-8. Las pacientes deben tener una función orgánica y medular normal:
    A) Hemoglobina ≥ 10,0 g / dL.; B) Recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109 / L.
    C) Número de plaquetas ≥ 100 x 10 9 /L; D) Bilirrubina total ≤ 1,5 x límite superior institucional de la normalidad (LSN); E) Aspartato aminotransferasa / transaminasa oxaloacética glutámica (ASAT / SGOT)) y Alanina aminotransferasa / transaminasa glutamica sérica (ALAT / SGPT) ≤ 2,5 x LSN, a menos que existan metástasis hepáticas, en cuyo caso deben ser ≤ 5 x LSN; F) Creatinina sérica ≤ 1,5 x ULN institucional; G) Pacientes que no reciben medicación anticoagulante y que tienen un índice normalizado internacional (INR) ≤ 1,5 y un tiempo de protrombina activado (aPTT) ≤ 1,5 x ULN. Se permite el uso de anticoagulantes orales o parenterales de dosis completa, siempre y cuando el INR o APTT se encuentre dentro de los límites terapéuticos (según el estándar médico del centro) y si la paciente está en una dosis estable de anticoagulantes durante al menos dos semanas al momento de Aleatorización; H) Tira reactiva de orina para proteinuria <2+. Si el resultado con tira reactiva es ≥2 +, se debe comprobar un valor ≤1 g en orina de 24 horas; I) Presión arterial normal o hipertensión controlada y controlada adecuadamente (PA sistólica ≤ 150mmHg y presión diastólica ≤100mmHg).
     I-9. Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0-1.
    E.4Principal exclusion criteria
    E-1.Non-epithelial ovarian tumor, the fallopian tube or the peritoneum (i.e. germ cell tumors).
    E-2.Ovarian tumors of low malignant potential (borderline tumors).
    e-3.Synchronous primary endometrial cancer (Ca) unless a) Stage <II; b) <60 years old (y) at time of diagnosis of endometrial Ca with IA or IB grade (G) 1 or G2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old (y) at time of endometrial Ca diagnosis with stage IA G1 or G2 endometrioid adenocarcinoma. c) Serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
    E-4.Other malignancy within last 5 years (y) except cervix or breast in situ carcinoma, breast cancer ≥ 3y free of disease and treatment, type I stage I endometrial Ca.
    E-5.Radiotherapy within 6 weeks (w) prior to study treatment.
    E-6.Major surgery within 4w of starting study treatment or patients who have not completely recovered from effects of any major surgery.
    E-7.Previous allogeneic bone marrow transplant or previous solid organ transplantation.
    E-8.Other simultaneous chemotherapy, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous RT during treatment period (hormonal replacement therapy is permitted).
    E-9.Prior treatment with CD137 agonists or immune checkpoint blockers, anti−PD1, or anti−PDL1 therapeutic antibodies or anti-CTLA 4.
    E-10.Systemic immunostimulants within 4w or 5 half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 (D1C1).
    E-11.Systemic corticosteroids or other systemic immunosuppressive medications within 2w prior to D1C1 or anticipated requirement for systemic immunosuppressors during the trial. Detailed exceptions described in study protocol.
    E-12.Autoimmune disease. Detailed exceptions described in study protocol.
    E-13.Idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
    pneumonitis, organizing pneumonia, or evidence of active pneumonitis. Detailed exceptions described in study protocol.
    E-14.Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). Patients with active hepatitis B or hepatitis C. Detailed exceptions described in study protocol.
    E-15.Signs or symptoms of infection within 2 weeks prior to D1C1.
    E-16.Administration of a live, attenuated vaccine within 4w prior to C1D1, or anticipation that such a live attenuated vaccine will be required during the study.
    E-17.Current or recent (within 10d prior to randomization) chronic use of aspirin > 325 mg/day.
    E-18.Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
    E-19.Inadequately controlled HTN.
    E-20.Clinically significant (e.g. active) cardiovascular disease.
    E-21.Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
    E-22.Left ventricular ejection fraction by MUGA/ECHO below the institutional lower limit of normal (applicable for patients intended to be treated with PLD).
    E-23.Previous Cerebro-Vascular Accident, Transient Ischemic Attack or Sub-Arachnoids Hemorrhage within 6m prior to randomization.
    E-24.Evidence of hemorrhagic disorders within 6m prior to randomization.
    E-25.Bleeding diathesis or significant coagulopathy (in absence of coagulation).
    E-26.Clinical suspicion of brain metastases or spinal cord compression.
    E-27.History or evidence upon neurological examination of central nervous system disease, unless adequately treated with standard therapy.
    E-28.Significant traumatic injury during 4w prior to randomization.
    E-29.Non-healing wound, active ulcer or bone fracture. Detailed exceptions described in study protocol.
    E-30.VEGF therapy related abdominal fistula or gastrointestinal perforation.
    E-31.Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
    E-32.Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
    E-33.Any other disease, metabolic dysfunction, physical examination finding or laboratory finding with reasonable suspicion of a disease/condition that contraindicates the use of an investigational drug or puts the patient at high risk for tx related complications.
    E-34.Women of childbearing potential (<2y after last menstruation and not surgically sterile) not willing to use highly-effective means of contraception during study and for 6m after the last dose of study medication.
    E-35.Pregnant or lactating women.
    E-36.Severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
    E-37.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation.
    E-38.Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, carboplatin, gemcitabine, paclitaxel, pegylated liposomal doxorubicin, or their excipients.
    E-1.Tumor de ovario de origen (es decir, tumores celulares germinales).
    E-2.Tumores ováricos de bajo potencial maligno (tumores borderline).
    E-3.Cáncer (Ca) endometrial primario concomitante, excepto a)Estadio <II; b) <60 años (a) a al diagnóstico del Ca endometrial con adenocarcinoma endometrioide IA o IB y grado (G) 1 o 2 o IA y G3 O ≥ 60a al diagnóstico del Ca endometrial con adenocarcinoma endometrioide IA y G1 o G2. c) Adenocarcinoma seroso o de células claras o carcinosarcoma endometrial no son elegibles.
    E-4.Otra neoplasia maligna en los 5a previos, salvo cérvix o mama in situ, mama ≥ 3a libre de enfermedad y tratamiento (tx), endometrio tipo I estadio I.
    E-5.Radioterapia (RT) en las 6 semanas (s) previas al tx del estudio.
    E-6.Cirugía mayor en las 4s previas al inicio del tx del estudio o pacientes no recuperadas post cirugía mayor.
    E-7.Alotrasplante de médula ósea o de organos sólidos.
    E-8.Otra quimioterapia simultánea, cualquier tx antineoplásico o tx hormonal antineoplásico o RT simultánea durante el tx (se permite reemplazo hormonal).
    E-9.Tx previo con agonistas de CD137 o checkpoints, anti−PD1 o anticuerpos terapéuticos anti−PDL1 o anti-CTLA 4.
    E-10.Tx con inmunoestimuladores sistémicos en las 4s previo a D1C1 o en un período de 5 semividas del fármaco (lo que sea menor).
    E-11.Corticosteroides sistémicos u otro inmunodepresor sistémica 2s previo a D1C1. Excepciones detalladas en el protocolo.
    E-12.Enfermedad autoinmune. Excepciones detalladas en el protocolo.
    E-13.Fibrosis pulmonar idiopática (incluida neumonitis), neumonitis inducida por fármacos, neumonía organizada o neumonitis activa. Excepciones detalladas en el protocolo.
    E-14.Inmunodeprimidos: serología positiva para VIH, hepatitis B o C activa. Excepciones detalladas en el protocolo.
    E-15.Signos/síntomas de infección activa 2s previo a C1D1.
    E-16.Administración vacuna con microorganismos vivos atenuados, en las 4s anteriores al D1C1 o previsión de administración durante el estudio. Excepciones detalladas en el protocolo.
    E-17.Uso crónico actual o reciente (en los 10d previos a la aleatorización) de aspirina >325mg/día.
    E-18.Antecedentes de crisis hipertensiva (CTCAE grado 4) o encefalopatía hipertensiva.
    E-19.Hipertensión arterial no controlada.
    E-20.Enfermedad cardiovascular (ej. activa) clínicamente significativa.
    E-21.QTc >470 ms en 2 o más mediciones en 24h o antecedentes familiares de síndrome de QT prolongado (ECG en reposo).
    E-22.Fracción de eyección ventricular izquierda por MUGA/ECHO por debajo del límite inferior a la normalidad institucional (aplicable a pacientes en las que esté previsto administrar DLP).
    E-23.Accidente cerebrovascular, ataque isquémico transitorio o hemorragia subaracnoidea previos en los 6 m anteriores a la aleatorización.
    E-24.Antecedentes o signos de trastornos hemorrágicos en los 6m previos a la aleatorización.
    E-25.Pruebas de diátesis hemorrágica o coagulopatía significativa (en ausencia de coagulación).
    E-26.Antecedente o sospecha de metástasis cerebrales o compresión medular.
    E-27.Antecedentes o signos tras exploración neurológica de la enfermedad del sistema nervioso central, salvo que se traten de forma suficiente con tratamiento médico de referencia.
    E-28.Lesión traumática significativa durante las 4s previas a la aleatorización.
    E-29.Herida, úlcera activa o fractura ósea sin cicatrizar. Excepciones detalladas en el protocolo.
    E-30.Antecedente de tratamiento contra el VEGF relacionado con fístula abdominal o perforación gastrointestinal.
    E-31.Obstrucción intestinal actual clínicamente relevante, incluida enfermedad suboclusiva, relacionada con enfermedad subyacente.
    E-32.Signos de aire libre abdominal no explicado por paracentesis o intervención quirúrgica reciente.
    E-33.Pruebas de cualquier otra enfermedad, disfunción metabólica, hallazgo
    de exploración física o de laboratorio que provoque una sospecha razonable de una enfermedad o afección que contraindique el uso de un fármaco en investigación o suponga un gran riesgo para la paciente de sufrir complicaciones relacionadas con el tratamiento.
    E-34. Mujeres en edad fértil (<2a después de la última menstruación y sin esterilización quirúrgica) que no estén dispuestas a utilizar métodos anticonceptivos altamente eficaces durante el estudio y los 3m posteriores a la última dosis de la medicación del estudio.
    E-35.Embarazadas o en período de lactancia.
    E-36.Antecedentes de reacciones alérgicas graves, anafilácticas u otras reacciones de hipersensibilidad a anticuerpos quiméricos o humanizados o a proteínas de fusión.
    E-37. Hipersensibilidad o alergia conocida a productos biofarmacéuticos producidos en células de ovario de hámster chino o a cualquier componente de la formulación de atezolizumab.
    E-38. Reacción de hipersensibilidad conocida o alergia a fármacos químicamente relacionados con bevacizumab, carboplatino, gemcitabina, paclitaxel, DLP o sus excipientes que contraindiquen la participación de la paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free-survival (PFS1).
    PFS1 is defined as the time from randomization until the date of the first objective radiological disease progression according to investigator assessment of RECIST version 1.1 or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized study treatment or receives another anti-cancer therapy prior to progression
    Progresión de supervivencia libre (PFS1).
    PFS1 se define como el tiempo desde la randomización hasta la fecha de la primera progresión objetiva de la enfermedad radiológica de acuerdo con la evaluación del investigador de RECIST versión 1.1 o la muerte (por cualquier causa en ausencia de progresión) independientemente de si la paciente se retira del estudio o recibe tratamiento de otra terapia contra el cáncer antes de la progresión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    278 events observed for the primary analysis.
    Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
    278 casos observados para el análisis primario.
    Las pacientes que no hayan progresado o hayan fallecido en el momento del análisis serán registrados en el momento de la última fecha de evaluación desde su última valoraación evaluable de RECIST.
    E.5.2Secondary end point(s)
    Secondary supportive objectives
    To determine the efficacy of atezolizumab compared to placebo on:

    • Time from randomization to second subsequent therapy or death (TSST)
    • Health-related Quality of Life (HRQoL) and patient reported outcomes (PROs) as measured by EORTC QLQ-C30 and OV28
    •Long term survival using the cure rate modelling
    •Overall survival (OS)

    Others secondary objectives

    To determine the efficacy of atezolizumab compared to placebo on:

    • Objective Response Rate (ORR) as assessed by RECIST v1.1 and irRECIST
    • PFS1 as assessed per irRECIST
    • Characterization of CA-125 tumor marker levels and their relation to tumor response and PFS1 as measured by RECISTv 1.1 and irRECIST
    • Time from randomization to first subsequent therapy or death (TFST)
    • Time from randomization to second progression (PFS2)

    Others secondary objectives
    To determine the efficacy of atezolizumab compared to placebo in the PD-L1-ve and PD-L1 +ve subgroups

    To assess the safety and tolerability of atezolizumab compared to placebo

    To evaluate the impact of treatment and disease on resource use as measured by different criteria including EuroQoL 5 Dimension (EQ-5D) questionnaire

    Exploratory objectives
    1. To explore pre-planned subgroups analyses of efficacy (PFS) based on relevant potential prognostic factors, including stratification factors, as well as on the performance or not of secondary cytoreductive surgery.
    2. To evaluate the relationship between the expression of PD-L1, tumor mutational load and intraepithelial TILs with ORR and PFS.
    3. To evaluate the relationship between the expression of PD-L1, tumor mutational load and intraepithelial TILs with ORR and PFS during experimental treatment and at the subsequent line of therapy.
    4. To assess immune-related and other potential predictive and prognostic exploratory biomarkers in de novo/archival tissue and blood and their association with disease status and/or efficacy as defined by ORR and PFS during experimental treatment and at the subsequent line of therapy .
    5. To evaluate the utility of biopsy at the time of apparent disease progression to distinguish apparent increases in tumor volume related to immunomodulatory activity of atezolizumab (i.e., pseudoprogression/tumor immune infiltration) from true disease progression as determined by confirmatory CT scan for disease progression and PFS.
    6. To explore whether resistance mechanisms to atezolizumab plus bevacizumab versus placebo plus bevacizumab alone can be identified through analysis of tumor and blood samples – archival tumor, fresh tumor biopsy and blood sample at baseline (mandatory), tumor biopsy and blood sample on progression (optional).
    7. To collect and store ctDNA (according to each country’s local and ethical procedures) for future exploratory research into genes/genetic variation that may influence response (i.e., distribution, safety, tolerability and efficacy) to study treatments
    Objetivos secundarios de apoyo
    Para determinar la eficacia de atezolizumab en comparación con placebo en:

    • Tiempo desde la randomización hasta la segunda terapia o muerte (TSST)
    • Calidad de vida relacionada con la salud (HRQoL) y los resultados informados por el paciente (PROs) según lo determinado por EORTC QLQ-C30 y OV28
    • Supervivencia a largo plazo utilizando el modelo de tasa de curación
    • Supervivencia general (SO)

    Otros objetivos secundarios

    Para determinar la eficacia de atezolizumab en comparación con placebo en:

    • Tasa de Respuesta Objetiva (ORR) evaluada por RECIST v1.1 e irRECIST
    • PFS1 evaluado por irRECIST
    • Caracterización de los niveles de marcadores tumorales CA-125 y su relación con la respuesta tumoral y PFS1, medida por RECISTv 1.1 e irRECIST
    • Tiempo desde la randomización hasta la primera terapia o muerte (TFST)
    • Tiempo desde la randomización hasta la segunda progresión (PFS2)

    Otros objetivos secundarios
    Para determinar la eficacia de atezolizumab en comparación con placebo en los subgrupos PD-L1-ve y PD-L1 + ve

    Evaluar la seguridad y tolerancia del atezolizumab en comparación con el placebo

    Evaluar el impacto del tratamiento y la enfermedad sobre el uso de los recursos, medido por diferentes criterios, incluido el cuestionario EuroQoL 5 Dimension (EQ-5D)

    Objetivos exploratorios
    1. Explorar los análisis de la eficacia de los subgrupos pre-planificados (PFS) basados ​​en los pronósticos de factores potenciales relevantes, incluyendo factores de estratificación, así como en la realización o no de la cirugía citorreductora secundaria.
    2. Evaluar la relación entre la expresión de PD-L1, carga mutacional tumoral y TIL intraepitelial con ORR y PFS.
    3. Evaluar la relación entre la expresión de PD-L1, carga mutacional tumoral y TILs intraepiteliales con ORR y PFS durante el tratamiento experimental y en la línea de tratamiento posterior.
    4. Evaluar los biomarcadores exploratorios predictivos y pronósticos potencialmente inmunológicos y otros potenciales en tejidos y sangre de novo / archival y su asociación con el estado y / o la eficacia de la enfermedad según lo definido por ORR y PFS durante el tratamiento experimental y en la línea subsiguiente de terapia.
    5. Evaluar la utilidad de la biopsia en el momento de la aparente progresión de la enfermedad para distinguir los aumentos aparentes en el volumen tumoral relacionados con la actividad inmunomoduladora de atezolizumab (es decir, pseudoproducción / infiltración inmune tumoral) de la verdadera progresión de la enfermedad según se determina mediante TC confirmatorio para la progresión de la enfermedad Y PFS.
    6. Explorar si los mecanismos de resistencia a atezolizumab más bevacizumab versus placebo más bevacizumab sólo pueden ser identificados a través del análisis del tumor y muestras de sangre - tumor de archivo, biopsia de tumor fresco y muestra de sangre en la línea de base (obligatorio), biopsia de tumor y muestra de sangre en progresión (Opcional).
    7. Recopilar y almacenar ADNct (de acuerdo a los procedimientos locales y éticos de cada país) para futuras investigaciones exploratorias sobre genes / variación genética que puedan influir en la respuesta (es decir, distribución, seguridad, tolerancia y eficacia) para estudiar los tratamientos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - This first interim safety analysis will be performed after the first 36 patients had received 1 cycle of treatment and second safety interim analysis will be done after 45 patients had received 2 cycles of treatment
    - 278 events observed for the primary analysis.
    - The IDMC will meet on a regular basis and will be responsible for independently evaluation of the safety for the patients. IDMC will make recommendations concerning the conduct of the trial
    - No interim efficacy analysis will be planned during the trial
    - Este primer análisis provisional de seguridad se realizará después de que las primeras 36 pacientes hayan recibido 1 ciclo de tratamiento y se realizará un segundo análisis de seguridad después de que 45 pacientes hayan recibido 2 ciclos de tratamiento.
    - 278 eventos analizados para el análisis primario.
    - El IDMC se reunirá de forma regular y será responsable de la evaluación independiente de la seguridad de las pacientes. IDMC hará recomendaciones sobre la realización del ensayo.
    - No se planificará ningún análisis de eficacia provisional durante el ensayo.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    -Quality of life
    - Biomarkers
    -Calidad de vida
    - Biomarcadores
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Belgium
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Israel
    Norway
    Spain
    Sweden
    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
    Last Visit Last Subject
    Última visita de la última paciente
    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: 243
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 162
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 405
    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 post trial treatment will be according to the local standard practices
    El posterior tratamiento al ensayo será de acuerdo con las prácticas estándar locales
    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 ENGOT
    G.4.3.4Network Country European Union
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Grupo Español de Investigación en Cáncer de Ovario
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-19
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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