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    Summary
    EudraCT Number:2015-005471-24
    Sponsor's Protocol Code Number:GINECO-OV236b
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-09
    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 ConcernedAustria - BASG
    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
    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.
    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
    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 organisation
    B.5.2Functional name of contact point
    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/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) 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.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 late relapse of epithelial ovarien cancer, fallopian tube or peritoneal cancer treated with chemotherapy , bevacizumab and a anti PD-L1
    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.
    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 21.1
    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 endpoint measure is progression free survival (PFS1), where the date of progression is based on investigator assessment using the Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1)
    E.2.2Secondary objectives of the trial
    Supportive secondary obj:
    To determine the efficacy of atezolizumab compared to placebo on
    • Time from randomization to 2nd subsequent therapy or death
    • Health-related QoL and PROs as measured by EORTC QLQ-C30 +OV28
    • Long term survival using cure rate modelling
    • Overall survival

    - Other secondary obj
    To determine the efficacy of atezolizumab compared to placebo on
    • Objective Response Rate (ORR) as assessed by RECIST v1.1+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 +irRECIST
    • Time from randomization to 1st subsequent therapy or death (TFST)
    • Time from randomization to 2nd progression (PFS2)
    To assess safety and tolerability of atezo compared to placebo
    To evaluate impact of TTT and disease on resource use as measured by diff. criteria incl EQ-5D questionnaire
    To characterise atezo PK in combination with beva + chemo and determine ADAs' incidence
    E.2.3Trial contains a sub-study No
    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

    For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
    E.4Principal exclusion criteria
    E-1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
    E-2. Ovarian tumors of low malignant potential (e.g. borderline tumors)
    E-3. Patients with synchronous primary endometrial cancer unless both of the following criteria are met:
    a) stage < II,
    b) Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1or 2 endometrioid adenocarcinoma.
    c) Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
    E-4. Other malignancy within the last 5 years except cervix or breast in situ carcinoma, breast cancer ≥ 3 years free of disease and treatment, type I stage I endometrial cancer.
    E-5. Patients receiving radiotherapy within 6 weeks prior to study treatment.
    E-6.Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery.
    E-7. Previous allogeneic bone marrow transplant or previous solid organ transplantation.
    E-8. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
    E-9. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies or anti-CTLA 4.
    E-10. Treatment with systemic immunostimulatory agents
    E-11. Treatment with systemic corticosteroids or other systemic immunosuppressive medications.
    a) The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
    b) Prophylactic anti-emetic corticosteroids will be avoided if possible in patients treated with pegylated liposomal doxorubicin-carboplatin or gemcitabine-carboplatin regimen. The use of corticosteroids is allowed as premedication for paclitaxel-based regimen and/or premedication in case of carboplatin hypersensitivity.
    E-12. History of autoimmune disease
    E-13. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis. Radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted
    E-14. Immunocompromised patients,
    E-15. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
    E-16. Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
    E-17. Current or recent (within 10 days 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, including:
    a) Myocardial infarction or unstable angina within ≤ 6 months of randomization,
    b) New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
    c) Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),
    d) Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)
    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. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
    E-23. History or evidence of hemorrhagic disorders within 6 months prior to randomization.
    E-24. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
    E-25. History or clinical suspicion of brain metastases or spinal cord compression.
    E-26. Significant traumatic injury during 4 weeks prior to randomization.
    E-27. History of VEGF therapy related abdominal fistula or gastrointestinal perforation.
    E-28. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
    E-29. Women of childbearing potential (<2 years after last menstruation and not surgically sterile) not willing to use highly-effective means of contraception during the study and for 3 months after the last dose of study medication
    E-30. Pregnant or lactating women.
    E-31.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
    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
    E.5.1.1Timepoint(s) of evaluation of this end point
    445 events observed for the co-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.
    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)


    Other 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)

    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

    To characterise atezolizumab PK in combination with bevacizumab and chemotherapy and to determine the incidence of ADAs.

    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 explore the time to next severe toxicity (grade 4 neutropenia, lasting > 7 days, grade > 3 febrile neutropenia, grade 4 thrombocytopenia with bleeding or platelet Transfusion, grade > 3 non-hematological toxicity) in both arms.
    3. To explore the correlation between geriatric assessment and efficacy and tolerancy of atezolizumab versus Placebo for patients >= 70 years old)
    4. 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.
    5. 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 .
    6. To evaluate the relationship between PD-L1, TILs and biomarker status in archival tissue and in de novo tumor specimens.
    7. 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.
    8. 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, de novo tumor biopsy and blood sample at baseline (mandatory), tumor biopsy and blood sample on progression (optional).
    9. 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
    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
    - 445 events observed for the co-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
    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 Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    -Quality of life
    - Biomarkers
    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 concerned4
    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
    France
    Germany
    Israel
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 600
    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
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-17
    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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