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    Summary
    EudraCT Number:2018-000312-24
    Sponsor's Protocol Code Number:BGB-A317-305
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-19
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-000312-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised, Double blind, Placebo controlled Phase 3 study comparing Efficacy and Safety of Tislelizumab plus Chemotherapy versus Placebo plus Chemotherapy in patients with Gastric Cancer
    A.4.1Sponsor's protocol code numberBGB-A317-305
    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 SponsorBeiGene, Ltd
    B.1.3.4CountryUnited States
    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 supportBeiGene Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene Ltd
    B.5.2Functional name of contact pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street Addressc/o BeiGene USA Inc., 1900 Powell Street, Suite 500
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post code94608
    B.5.3.4CountryUnited States
    B.5.6E-mailBeiGeneClinicalSupportUS@beigene.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 nameTislelizumab
    D.3.2Product code BGB-A317
    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 INNtislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Gastric Cancer
    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 10001158
    E.1.2Term Adenocarcinoma gastric stage IV with metastases
    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 compare overall survival of tislelizumab plus chemotherapy versus
    placebo plus chemotherapy in the programmed cell death protein ligand1 positive (PDL1+) and intent-to-treat analysis sets
    E.2.2Secondary objectives of the trial
    • To compare progression-free survival per Response Evaluation Criteria
    in Solid Tumors 1.1 as assessed by investigators of tislelizumab plus
    chemotherapy versus placebo plus chemotherapy in the programmed cell
    death protein ligand-1 positive and intent-to-treat analysis sets
    • To evaluate overall response rate, and duration of response, per
    Response Evaluation Criteria in Solid Tumors 1.1 as assessed by
    investigators
    • To evaluate European Organization for Research and Treatment of
    Cancer Quality of Life Questionnaire Gastric Cancer Score, European
    Organization for Research and Treatment of Cancer Quality of Life
    Questionnaire-Core 30 Score and European Quality of Life 5-Dimensions
    5-Levels Health Questionnaire Score
    • To evaluate the safety and tolerability profile of tislelizumab or placebo
    plus chemotherapy
    • To evaluate disease control rate, clinical benefit rate, and time to
    response per Response Evaluation Criteria in Solid Tumors 1.1 as
    assessed by investigators
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent and can understand and comply with the requirements of the study
    2. Adult patients (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.
    3. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
    4. At least 1 measurable lesion as defined per RECIST v1.1 as determined by investigator assessment.
    5. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. Note: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
    6. Patients must be able to provide tumor tissues.
    7. ECOG PS ≤ 1 within 7 days prior to randomization
    8. Adequate organ function:
    a. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90 g/L. Note: Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection
    b. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73 m2. (Appendix 8)
    c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    d. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)
    e. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy and PT values are within the intended therapeutic range of the anticoagulant
    f. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
    g. Albumin ≥ 3.0 g/dL or 30 g/liter
    9. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control.
    10. Non-sterile males must be willing to use a highly effective method of birth control.
    E.4Principal exclusion criteria
    1. Patient has squamous cell or undifferentiated or other histological
    type GC
    2. Active leptomeningeal disease or uncontrolled brain metastasis.
    3. Active autoimmune diseases or history of autoimmune diseases that
    may relapse.
    4. Any active malignancy ≤ 2 years before randomization, with the
    exception of the specific cancer under investigation in this study and any
    locally recurring cancer that has been treated curatively.
    5. Uncontrollable pleural effusion, pericardial effusion, or ascites
    requiring frequent drainage at least once a week) and/or diuretics
    within 7 days prior to randomization (The cytological confirmation of any
    effusion is permitted).
    6. Have clinically significant bleeding (CTCAE ≥ Grade 2) from the
    gastrointestinal (GI) tract within month prior to randomization
    7. Have a history of ≥ Grade 2 (CTCAE) GI perforation and/or fistulae
    (including prior gastric fistula operation) within 6 months prior to
    randomization
    8. Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)
    9. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
    10. Any condition that requires systemic treatment with either
    corticosteroids (> 10 mg daily of prednisone or equivalent) or other
    immunosuppressive medication ≤ 14 days before randomization
    11. With history of interstitial lung disease, non-infectious pneumonitis
    or uncontrolled systemic diseases, including diabetes, hypertension,
    pulmonary fibrosis, acute lung diseases, etc.
    12. With severe chronic or active infections requiring systemic
    antibacterial, antifungal or antiviral therapy, including tuberculosis
    infection, etc.
    13. A known history of HIV infection
    14. Patients with cardiovascular risk factors.
    15. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other
    antibody or drug specifically targeting T-cell co-stimulation or
    checkpoint pathways
    E.5 End points
    E.5.1Primary end point(s)
    • Overall survival – defined as the time from the date of randomization
    to the date of
    death due to any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Overall survival – defined as the time from the date of randomization
    to the date of death due to any cause
    E.5.2Secondary end point(s)
    • Progression-free survival as assessed by investigators
    • Overall response rate as assessed by investigators
    • Duration of response (DOR) as assessed by investigators – defined as
    the time from the first determination of an objective response per
    Response Evaluation Criteria in Solid Tumors v1.1, until the first
    documentation of progression or death, whichever occurs first
    • Change from baseline in European Organization for Research and
    Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module
    QLQ-STO22 Score and change from baseline in European Organization
    for Research and Treatment of Cancer Quality of Life Questionnaire-Core
    30 Score and European Quality of Life 5-Dimensions 5-Levels Health
    Questionnaire Score
    • The incidence and severity of adverse events according to National
    Cancer Institute Common Terminology Criteria for Adverse Events v5.0
    • Disease control rate (ie, proportion of complete response + partial
    response + stable disease), clinical benefit rate (ie, proportion of
    complete response + partial response + durable stable disease), and
    time to response (ie, time from randomization to the first determination
    of an objective response) per Response Evaluation Criteria in Solid
    Tumors 1.1 as assessed by investigators
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall response rate: Defined as the proportion of patients whose
    best overall response is complete response or partial response per
    Response Evaluation Criteria in Solid Tumors v1.1
    • Duration of response – defined as the time from the first determination
    of an objective response per Response Evaluation Criteria in Solid
    Tumors v1.1, until the first documentation of progression or death,
    whichever occurs first
    • Progression-free survival– defined as the time from the date of
    randomization to the date of the first objectively documented tumor
    progression, assessed per Response Evaluation Criteria in Solid Tumors
    v1.1, or death, whichever occurs first.
    • Disease control rate, clinical benefit rate and time to response per
    Response Evaluation Criteria in Solid
    Tumors 1.1
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Puerto Rico
    Taiwan
    China
    Japan
    Korea, Republic of
    Russian Federation
    United Kingdom
    United States
    France
    Germany
    Italy
    Poland
    Romania
    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 study will continue until the last patient has died, becomes lost to follow up, or withdraws from study, or until sponsor decides to terminate the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months43
    E.8.9.2In all countries concerned by the trial days0
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 380
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 720
    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)
    None
    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 Decision2019-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-06
    P. End of Trial
    P.End of Trial StatusOngoing
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