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    Summary
    EudraCT Number:2017-003691-31
    Sponsor's Protocol Code Number:YO40245
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-003691-31
    A.3Full title of the trial
    A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB IN COMBINATION WITH BEVACIZUMAB COMPARED WITH SORAFENIB IN
    PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab in Combination with Bevacizumab Compared with Sorafenib in Patients with Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
    A.4.1Sponsor's protocol code numberYO40245
    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 Yes
    D.2.1.1.1Trade name Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameatezolizumab
    D.3.2Product code RO5541267
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product 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 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 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 Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/364
    D.3 Description of the IMP
    D.3.1Product nameSorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSORAFENIB
    D.3.9.1CAS number 284461-73-0
    D.3.9.4EV Substance CodeSUB23139
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Locally advanced or Metastatic hepatocellular carcinoma (HCC)
    E.1.1.1Medical condition in easily understood language
    HCC is a primary malignancy of the liver and occurs predominantly in patients with underlying chronic liver disease and cirrhosis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077738
    E.1.2Term Hepatocellular carcinoma metastatic
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    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 10073071
    E.1.2Term Hepatocellular carcinoma
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10077736
    E.1.2Term Hepatocellular carcinoma stage III
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10077737
    E.1.2Term Hepatocellular carcinoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of atezolizumab + bevacizumab compared with
    sorafenib based on overall survival (OS) and progression-free survival
    (PFS) as determined by the independent review facility (IRF) according
    to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    E.2.2Secondary objectives of the trial
    To evaluate :
    • efficacy of atezolizumab + bevacizumab compared with sorafenib
    based on objective response (OR)
    • time to progression (TTP), duration of response (DOR) determined by
    investigator ; IRF according to RECIST v 1.1 and OR, PFS, TTP, DOR by
    IRF according to HCC modified (m) RESIST v 1.1
    • the association of prespecified biomarkers with efficacy of
    atezolizumab+ bevacizumab compared with sorafenib based on PFS as
    determined by the investigator and by an IRF according to RECIST v1.1 and OS
    • patient-reported outcome of disease/treatment-related symptoms,
    health-related quality of life / global health status, function experienced
    by patients on atezolizumab + bevacizumab versus sorafenib based on
    time to deterioration (TTD)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients
    - Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
    - No prior systemic therapy (including systemic investigational agents) for HCC
    - At least 1 measurable (per RECIST 1.1) untreated lesion
    - Patients who received prior local therapy are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1
    - Pre-treatment tumor tissue sample (if available)
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
    - Child-Pugh class A within 7 days prior to randomization
    - Adequate hematologic and end-organ function
    - Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade <= 1 prior to study entry, with the exception of alopecia
    - Negative HIV test at screening
    - Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test
    - For patients with active hepatitis B virus, HBV DNA 500 IU/mL obtained within 28 days prior to initiation of study treatment and anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during
    the treatment period and for at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 6 months
    after the last dose of sorafenib. Women must refrain from donating eggs during this same period.
    - For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 6 months after the last dose of bevacizumab or 3 months after the last dose of sorafenib
    E.4Principal exclusion criteria
    - History of leptomeningeal disease, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
    - Active or history of autoimmune disease or immune deficiency,
    - Known active tuberculosis, moderate or severe ascites
    - Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
    - History of congenital long QT syndrome, or corrected QT interval > 500 ms at screening and uncorrectable electrolyte disorder affecting serum level of potassium, calcium, or magnesium
    - Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major
    surgical procedure during the study
    - History of malignancy other than HCC within 5 years prior to screening,
    apart from malignancies with a negligible risk of metastasis or death and hepatic encephalopathy
    -Severe infection within 4 weeks prior to initiation of study treatment, or any active infection that, in the opinion of the investigator, could impact patient safety
    - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
    - Prior allogeneic stem cell or solid organ transplantation, Prior treatment with CD137 agonists or immune checkpoint blockade
    therapies, including anti- cytotoxic T-lymphocyte-associated protein 4, anti- Programmed death (PD)-1, and anti-PD-Ligand 1 therapeutic antibodies
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
    - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation
    - Fibrolamellar and sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
    - Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of
    atezolizumab, 6 months after the last dose of bevacizumab, or 6 months after the last dose of sorafenib
    - Patients with untreated or incompletely treated esophageal and/or
    gastric varices with bleeding or high-risk for bleeding
    - A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
    - Co-infection of hepatitis B and C virus
    - Symptomatic, untreated, or actively progressing central nervous system metastases
    - Uncontrolled tumor-related pain
    - Pleural effusion, pericardial effusion, or ascites requiring recurrent
    drainage procedures
    - Uncontrolled or symptomatic hypercalcemia
    - Treatment with investigational therapy within 28 days prior to study treatment
    - Strong CYP3A4 inducers within 14 days prior to study treatment
    - Systemic immunostimulatory agents and immunosuppressive
    medication within 4 weeks or 5 half-lives of the drug and 2 weeks prior to initiation of study treatment, or anticipation of need for systemic
    immunosuppressive medication during study
    - Inadequately controlled arterial hypertension
    - Significant vascular disease within 6 months prior to initiation of study
    - Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume
    - Evidence of bleeding diathesis or significant coagulopathy
    - Current or recent use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol and current or recent use of fulldose
    oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose
    - History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess and intra-abdominal
    inflammatory process within 6 months prior to study treatment, intestinal obstruction and/or clinical signs or symptoms of GI obstruction within 6 months prior to study treatment
    - Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
    -Radiotherapy within 28 days and abdominal/ pelvic radiotherapy
    within 60 days prior to initiation of study, except palliative radiotherapy to bone lesions within 7 days prior to study
    -Local therapy to liver within 28 days prior to initiation of study treatment
    -Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment, or abdominal
    surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to study or anticipation of need for major surgical procedure during the study
    E.5 End points
    E.5.1Primary end point(s)
    1. OS
    2. PFS as determined by the IRF according to RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From randomization to death from any cause
    2. From randomization to the occurrence of disease or death from any cause
    E.5.2Secondary end point(s)
    1. OR, by investigator and IRF per RECIST 1.1
    2. OR, by an IRF according to HCC mRECIST
    3. PFS, by investigator and IRF, per RECIST 1.1
    4. PFS, as determined by an IRF according to HCC mRECIST
    5. TTP, by investigator and IRF, per RECIST 1.1
    6. TTP, as determined by an IRF according to HCC mRECIST
    7. DOR, by investigator and IRF, per RECIST 1.1
    8. DOR, as determined by an IRF according to HCC mRECIST
    9. OS by baseline serum α-fetoprotein level
    10. Time to deterioration determined by European Organisation for
    Research and Treatment of Cancer quality-of-life questionnaire for
    cancer subscales, including HRQoL/GHS, physical and role functioning
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. At 6 months after the last patient is enrolled which us anticipated to occur Up to 22 months after FPI
    3-4. From randomization to the first occurrence of disease progression or death from any cause
    5-6. From the date of randomization to the date of the first documented tumor progression
    7-8. From the first occurrence of a documented objective response to disease progression or death from any cause
    9. From randomization to death from any cause
    10. From time from randomization to first deterioration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker and Health status objectives
    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 No
    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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number 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 EEA40
    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
    Argentina
    Australia
    Canada
    China
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Mexico
    Singapore
    Taiwan
    Thailand
    United States
    France
    Poland
    Spain
    Switzerland
    Czechia
    Germany
    Italy
    Russian Federation
    United Kingdom
    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
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs (i.e., last patient in the global and extended China enrollment phases combined) or safety follow-up is received from the last patient (global and extended China enrollment phases combined), whichever occurs later.
    In addition, the Sponsor may decide to terminate the study at any time.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 258
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 151
    F.4.2.2In the whole clinical trial 558
    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 will offer continued access to Roche IMPs (atezolizumab and bevacizumab)
    free of charge to eligible patients in accordance with the Roche Global Policy on
    Continued Access to Investigational Medicinal Product available at the following Web site:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-17
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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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