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    Summary
    EudraCT Number:2019-002491-14
    Sponsor's Protocol Code Number:WO41535
    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:2019-10-28
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-002491-14
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) PLUS BEVACIZUMAB VERSUS ACTIVE SURVEILLANCE AS ADJUVANT THERAPY IN PATIENTS WITH HEPATOCELLULAR CARCINOMA AT HIGH RISK OF RECURRENCE AFTER SURGICAL RESECTION OR ABLATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab (Anti-PD-L1 Antibody) plus Bevacizumab versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
    A.4.1Sponsor's protocol code numberWO41535
    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 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.3.4Pharmaceutical 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.3.9.4EV 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 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.3.4Pharmaceutical 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.3.9.4EV 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.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
    High-risk hepatocellular carcinoma (HCC)
    E.1.1.1Medical condition in easily understood language
    HCC is the most common hepatic malignancy worldwide. The primary risk factor for the development of HCC is cirrhosis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma 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
    To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance on the basis of recurrence-free survival (RFS) as determined by an IRF
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance on the basis of overall survival (OS), RFS after randomization as determined by the investigator and by an Independent Review Facility (IRF), time to recurrence (TTR), IRF-assessed RFS and investigator-assessed RFS rate after randomization and OS rate at 24 months and 36 months, Time to extrahepatic spread or macrovascular invasion after randomization
    2. To evaluate the safety of atezolizumab plus bevacizumab compared with active surveillance
    3. To characterize the PK profile of atezolizumab when given in combination with bevacizumab
    4. To evaluate the immune response to atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation within 4-12 weeks prior to randomization (not applicable for crossover)
    - Documented diagnosis of HCC that has been completely resected or ablated (not applicable for crossover)
    - Absence of major macrovascular (gross vascular) invasion and of the portal vein (Vp3 or Vp4) or any grade of macrovascular invasion in the hepatic vein or inferior vena cava (not applicable for crossover)
    Note: Patients undergoing resection with minor vascular invasion of the portal vein (Vp1 or Vp2) as detected by either imaging or pathological examination are allowed
    - Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest abdomen, pelvis, and head prior to and following curative procedure
    - Full recovery from surgical resection or ablation within 4 weeks prior to randomization
    - High risk for HCC recurrence after resection or ablation
    - For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
    - For patients with resected HCC, availability of a representative baseline tumor tissue sample
    - Negative HIV test at screening
    - Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests
    - For patients with active HBV: HBV DNA < 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study
    - Patients with HCV, either with resolved infection or chronic infection, are eligible
    - For patients enrolled in the extended China enrollment phase: current resident of mainland China and of Chinese ancestry
    - Performance of an esophagogastroduodenoscopy either before resection or ablation as part of pre-procedure work-up or during screening, and assessment and treatment of varices of all sizes per local standard of care prior to randomization
    - Eastern Cooperative Oncology Group Performance Status of 0 or 1
    - Child-Pugh Class A status
    - Adequate hematologic and end-organ function
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs for 5 months after the final dose of atezolizumab and for 6 months
    after the final dose of bevacizumab
    - For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm for during the treatment period and for 6 months after the final dose of bevacizumab to avoid exposing the embryo

    Additional Inclusion Criteria for Crossover for Patients in Arm B
    - Documentation of unequivocal recurrence as defined by European Association for the Study of the Liver Clinical Practice Guidelines or RECIST v1.1 criteria that is confirmed by the IRF
    - For Arm B patients who undergo surgical resection or ablation for first recurrence: full recovery from surgical resection or ablation within 4 weeks prior to Day 1 of Cycle 1
    - Availability of a representative tumor specimen obtained at the time of recurrence for exploratory biomarker research
    E.4Principal exclusion criteria
    - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
    - Evidence of residual, recurrent, or metastatic disease at randomization (not applicable for crossover)
    - Clinically significant ascites
    - History of hepatic encephalopathy
    - Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
    - Have received more than 1 cycle of adjuvant TACE following surgical resection
    - Active or history of autoimmune disease or immune deficiency
    - History of clinically significant idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
    - Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina
    - History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
    - Active tuberculosis
    - Severe infection within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, 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 Day 1 of Cycle 1
    - Prior allogeneic stem cell or solid organ transplantation
    - On the waiting list for liver transplantation
    - 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
    - Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab
    - Co-infection with HBV and HCV
    - Co-infection with HBV and hepatitis D viral infection
    - Clinically significant uncontrolled or symptomatic hypercalcemia
    - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
    - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations
    - Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE
    - Treatment with a live, attenuated vaccine within 4 weeks prior to Day 1 of Cycle 1, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
    - Treatment with investigational therapy within 4 weeks prior to Day 1 of Cycle 1
    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated proteinCTLA- 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
    - Treatment with systemic immune stimulatory agents within 4 weeks or 5 drug elimination half-lives prior to Day 1 of Cycle 1
    - Treatment with systemic immunosuppressive medication within 2 weeks prior to Day 1 of Cycle 1, or anticipation of need for systemic immunosuppressive medication during study treatment
    - Inadequately controlled arterial hypertension, based on an average of at least three BP readings at two or more sessions
    - History of hypertensive crisis or hypertensive encephalopathy
    - Significant vascular disease within 6 months prior to Day 1 of Cycle 1
    - History of hemoptysis within 1 month prior to Day 1 of Cycle 1
    - Evidence of bleeding diathesis or significant coagulopathy
    - Current or recent use of aspirin or current or recent treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
    - Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose
    - Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to Day 1 of Cycle 1
    - History of GI fistula, GI perforation, or intra-abdominal abscess within 6 months prior to Day 1 of Cycle 1
    - Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
    - Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
    - Major surgical procedure within 4 weeks prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
    - History of clinically significant intra-abdominal inflammatory process within 6 months prior to Day 1 of Cycle 1, including, but not limited to, peptic ulcer disease, diverticulitis, or colitis
    - Chronic daily treatment with a non-steroidal anti-inflammatory drug
    E.5 End points
    E.5.1Primary end point(s)
    1. IRF-assessed RFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 91 months
    E.5.2Secondary end point(s)
    1. OS rate at 24 months and 36 months
    2. OS
    3. RFS as determined by the investigator
    4. TTR
    5. Time to EHS or macrovascular invasion
    6. RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup
    7. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
    8. Change from baseline in targeted vital signs
    9. Change from baseline in targeted clinical laboratory test results
    10. Serum concentration of atezolizumab at specified timepoints
    11. Prevalence of anti-drug antibody (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study
    12. IRF-assessed RFS and investigator-assessed RFS rate at 24 and 36 months after randomization
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 24 months and 36 months
    2-7. Up to 91 months
    8. From baseline (Days –28 to –1) to treatment/Surveillance Discontinuation or <= 30 days after final cycle
    9. From baseline (Days -7 to -1) to treatment/Surveillance Discontinuation or <= 30 days after final cycle
    10 and 11. Day 1 Cycle 1-4, 8 and 12, 16 and at treatment/Surveillance Discontinuation or <= 30 days after final cycle
    12. At 24 months and 36 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 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
    immune response
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    active surveillance
    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 EEA47
    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
    New Zealand
    Peru
    Singapore
    Hong Kong
    Taiwan
    Australia
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Thailand
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Türkiye
    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 date when approximately 319 OS events have been observed for the final analysis of OS in the intent-to-treat (ITT) population
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months7
    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: 397
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 265
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 662
    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 Roche IMPs (atezolizumab and bevacizumab) or any other study treatments to patients who have completed the study
    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 Decision2019-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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