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    Summary
    EudraCT Number:2016-003472-52
    Sponsor's Protocol Code Number:YO39523
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-12
    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 ConcernedGermany - PEI
    A.2EudraCT number2016-003472-52
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB VERSUS PLACEBO ADMINISTERED IN COMBINATION WITH PACLITAXEL, CARBOPLATIN, AND BEVACIZUMAB TO PATIENTS WITH NEWLY-DIAGNOSED STAGE III OR STAGE IV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab Versus Placebo Given with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III/IV Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
    A.4.1Sponsor's protocol code numberYO39523
    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. Hoffman-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.5.4Telephone number+41 61688 1111
    B.5.5Fax number+41 61691 9319
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtezolizumab
    D.3.2Product code RO5541267/F03
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A, Tecentriq
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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/F02
    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.3.9.3Other descriptive nameAvastin
    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 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 GmbH
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A, Tecentriq
    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) Yes
    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 placeboSolution 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
    Ovarian cancer (OC), fallopian tube cancer (FTC), primary peritoneal cancer (PPC)
    E.1.1.1Medical condition in easily understood language
    OC, FTC, and PPC are diseases in which cells from either ovary, fallopian
    tube, or lining of the abdominal cavity grow abnormally into cancer cells
    and spread
    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 10033128
    E.1.2Term Ovarian cancer
    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 (Atezo) versus (vs) placebo (PL) in combination with paclitaxel (Pac)+ carboplatin (Carb)+ bevacizumab (Bev) in all OC, FTC, and PPC patients and in those with programmed death ligand-1 (PD-L1)−positive tumors

    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy and duration of efficacy of Atezo vs PL in combination with Pac + Carb +Bev among patients with measurable residual disease in the primary surgery group
    •To determine the impact of Atezo vs PL in combination with Pac + Carb +Bev on patient-reported abdominal symptoms of OC, as measured by two items from the abdominal and gastrointestinal symptom scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28)
    •To evaluate patient-reported outcomes of function and health-related quality of life( HRQoL) associated with Atezo vs PL in combination with Pac + Carb +Bev as measured by the functional and HRQoL scales of the EORTC QLQ Core 30 (QLQ-C30)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Receive a histologic diagnosis of epithelial OC, FTC, or PPC fulfilling the following criteria: epithelial tumors histologically of Mullerian origin
    - Patients with Stage III or Stage IV who have gross residual disease
    after primary surgery or who will undergo neoadjuvant treatment and planned interval surgery after Cycle 3
    - Eastern Cooperative Oncology Group performance status of 0, 1, or 2
    - Life expectancy > 12 weeks
    - Adequate hematologic and end-organ function test results
    - On a stable anticoagulant regimen, if therapeutic anticoagulation is indicated
    - For women of childbearing potential: agreement to remain abstinent
    or use contraceptive methods that have a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose
    of study drug and 6 months after the last dose of Bev, Pac, or Carb, whichever is later
    - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including all patientreported outcomes questionnaires
    - Availability of a representative formalin-fixed, paraffin-embedded tumor specimen (screening baseline tissue) in paraffin blocks or at least 20 unstained slides.
    - For patient enrolled in the extended China enrollment phase: residents
    in Mainland China, residents in Hong Kong and Taiwan of Chinese ancestry and enrolled at sites recognized by China FDA
    E.4Principal exclusion criteria
    - Received a current diagnosis of borderline epithelial ovarian tumor
    - Recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery
    - Non-epithelial ovarian tumors
    - Received prior radiotherapy to any portion of the abdomen or pelvis
    - Received prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant chemotherapy for ovarian, primary peritoneal or fallopian tube cancer
    - Received any hormonal, biological, and/or targeted therapy for epithelial ovarian, fallopian tube or primary peritoneal cancer
    - Synchronous primary endometrial cancer
    - Prior history of primary endometrial cancer, except if all of the mentioned conditions are met: Stage IA cancer, superficial myometrial invasion without lymphovascular invasion, and Grade < 3 or poorly differentiated subtypes which includes papillary serous, clear cell or other International Federation of Gynecological Oncologists Grade 3 lesions
    - With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - History of idiopathic pulmonary fibrosis, organizing pneumonia, druginduced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography scan
    - Known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the Atezo and/or Bev formulations
    - Active or history of autoimmune disease or immune deficiency that includes but is not limited to myasthenia gravis, myositis, autoimmune
    hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, or multiple sclerosis
    - Active tuberculosis, positive test for HIV
    - Significant cardiovascular disease (e.g., New York Heart Association cardiac disease, myocardial infarction infarction or cerebrovascular accident within 3 months before initiation of study treatment, unstable arrhythmias, or unstable angina)
    - Inadequately-controlled hypertension
    - Prior history of hypertensive crisis or hypertensive encephalopathy
    - Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
    - Current treatment with anti-viral therapy for HBV
    - Prior allogeneic bone marrow transplantation or solid organ transplant
    - Prior treatment with CD137 agonists or immune checkpoint blockade
    therapies, anti−PD-1, anti−PD-L1, or anti-cytotoxic T-lymphocyteassociated protein 4 therapeutic antibodies
    - Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment, systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
    - History of hypertensive crisis or hypertensive encephalopathy, hemoptysis (Grade ≥ 2) within 1 month prior to initiation of study treatment, abdominal fistula or gastrointestinal perforation within 6 months prior to initiation of study treatment
    - Evidence of active bleeding, bleeding diathesis, coagulopathy, tumor that involves major vessels
    - History of leptomeningeal disease
    - History of Grade ≥ 4 venous thromboembolism
    - Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable prior to initiation of study treatment
    - Significant vascular disease within 6 months prior to initiation of study treatment
    - Evidence of active bleeding, bleeding diathesis, coagulopathy, tumor that involves major vessels, abdominal free air not explained by paracentesis or recent surgical procedure
    - Core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
    - Major surgical procedures within 28 days of first bevacizumab dose
    - Clinical signs of gastrointestinal obstruction requiring routine parenteral hydration, parenteral nutrition, or tube feeding
    - Grade >= 2 peripheral neuropathy as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
    - Known history of severe hypersensitivity reactions to products that contain Cremophor® and severe allergic reactions to platinumcontaining compounds
    E.5 End points
    E.5.1Primary end point(s)
    1.Investigator-assessed progression-free survival
    2.Overall survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,2. Up to 56 months
    E.5.2Secondary end point(s)
    1.Objective response
    2.Duration of response
    3.Clinically-meaningful improvement in abdominal pain or bloating using scales of the EORTC QLQ-OV28 for patients in the neoadjuvant group
    4.Clinically-meaningful improvement, remaining stable or deterioration in function and HRQoL using scales of the EORTC QLQ-C30 for patients in the neoadjuvant group and the primary surgery group
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Up to 56 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA108
    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
    Australia
    Austria
    Belgium
    Brazil
    China
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Israel
    Italy
    Japan
    Korea, Republic of
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    Turkey
    United Kingdom
    United States
    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
    When the approximate preplanned numbers of deaths among the PD-L1-positive patients and the intent-to-treat(ITT) population have been observed.
    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 months5
    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 months8
    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: 715
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 585
    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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1300
    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)
    Currently, the Sponsor does not have any plans to provide atezolizumab or any other study treatments or interventions to patients who have completed the study. The Sponsor may evaluate whether to continue to provide atezolizumab 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 Decision2017-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-10
    P. End of Trial
    P.End of Trial StatusOngoing
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