<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03006705</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-4538-38</org_study_id>
    <nct_id>NCT03006705</nct_id>
  </id_info>
  <brief_title>Study of Adjuvant ONO-4538 With Resected Gastric Cancer</brief_title>
  <official_title>A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant&#xD;
      chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1&#xD;
      therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in&#xD;
      combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including&#xD;
      esophagogastric junction cancer) after D2 or more extensive lymph node dissection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse-free survival (RFS)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year OS rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year OS rate</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year RFS rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year RFS rate</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety will be analyzed through the incidence of adverse events, serious adverse events</measure>
    <time_frame>Up to 28 days from last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety will be analyzed through the incidence of laboratory abnormalities</measure>
    <time_frame>Up to 28 days from last dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Nivolumab group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).&#xD;
Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.&#xD;
S-1 therapy(maximum 1 year):&#xD;
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off&#xD;
CapeOX Therapy(maximum 6 months):&#xD;
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.&#xD;
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year).&#xD;
Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.&#xD;
S-1 therapy(maximum 1 year):&#xD;
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off&#xD;
CapeOX Therapy(maximum 6 months):&#xD;
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.&#xD;
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).</description>
    <arm_group_label>Nivolumab group</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>MDX-1106</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tegafur-gimeracil-oteracil potassium</intervention_name>
    <description>Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off</description>
    <arm_group_label>Nivolumab group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.</description>
    <arm_group_label>Nivolumab group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.</description>
    <arm_group_label>Nivolumab group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed adenocarcinoma of the stomach&#xD;
&#xD;
          -  Patients without a remnant cancer (R0) who have undergone gastrectomy&#xD;
&#xD;
          -  Gastric carcinoma according to the stage classification of AJCC/UICC TNM&#xD;
             Classification, 7th Edition on the basis of overall postoperative findings&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy,&#xD;
             hormone therapy) for gastric cancer&#xD;
&#xD;
          -  Multiple primary cancers&#xD;
&#xD;
          -  A current or past history of severe hypersensitivity to any other antibody products&#xD;
&#xD;
          -  Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune&#xD;
             disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Project Leader</last_name>
    <role>Study Director</role>
    <affiliation>Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Province Clinical Site</name>
      <address>
        <city>Anhui Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Clinical Site1</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Clinical Site2</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cuangdong Province Clinical Site</name>
      <address>
        <city>Cuangdong Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Province Clinical Site1</name>
      <address>
        <city>Guangdong Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Province Clinical Site2</name>
      <address>
        <city>Guangdong Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Province Clinical Site1</name>
      <address>
        <city>Henan Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Province Clinical Site2</name>
      <address>
        <city>Henan Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Clinical Site1</name>
      <address>
        <city>Jiangsu Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Clinical Site3</name>
      <address>
        <city>Jiangsu Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Clinical Site4</name>
      <address>
        <city>Jiangsu Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Clinical Site5</name>
      <address>
        <city>Jiangsu Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Clinical Site6</name>
      <address>
        <city>Jiangsu Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangxi Province Clinical Site2</name>
      <address>
        <city>Jiangxi Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Province Clinical Site</name>
      <address>
        <city>Jilin Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Province Clinical Site</name>
      <address>
        <city>Liaoning Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Province Clinical Site</name>
      <address>
        <city>Shanxi Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Clinical Site1</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Clinical Site2</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Province Clinical Site</name>
      <address>
        <city>Zhejiang Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhengjiang Province Clinical Site</name>
      <address>
        <city>Zhengjiang Province</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Clinical Site1</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Clinical Site2</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Clinical Site</name>
      <address>
        <city>Kamogawa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime Clinical Site</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime Clinicla Site</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu Clinical Site</name>
      <address>
        <city>Ōgaki</city>
        <state>Gifu</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma Clinical Site</name>
      <address>
        <city>Ota</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma Clinical Site</name>
      <address>
        <city>Takasaki</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Clinical Site</name>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Clinical Site 3</name>
      <address>
        <city>Hakodate</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Clinical Site 1</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Clinical Site2</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Clinical Site</name>
      <address>
        <city>Akashi</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Clinical Site</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Clinical Site</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishikawa Clinical Site</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Clinical Site</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Clinical Site</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Clinical Site</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miyagi Clinical Site</name>
      <address>
        <city>Osaki</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagano Clinical Site</name>
      <address>
        <city>Saku</city>
        <state>Nagano</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama Clinical Site</name>
      <address>
        <city>Kurashiki</city>
        <state>Okayama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site</name>
      <address>
        <city>Hirakata</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site</name>
      <address>
        <city>Toyonaka</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site</name>
      <address>
        <city>Ōsaka-sayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Clinical Site</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Clinical Site</name>
      <address>
        <city>Kitaadachi-gun</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Clinical Site</name>
      <address>
        <city>Sunto-gun</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tochigi Clinical Site</name>
      <address>
        <city>Shimotsuke</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Clinical Site</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Clinical Site</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Clinical Site</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Clinical Site</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Clinical Site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Clinical Site 1</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Clinical Site 2</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu Clinical Site</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Clinical Site1</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Clinical Site2</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Clinical Site3</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi Clinical Site</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto Clinical Site</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto Clinical Site</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Clinical Site</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site1</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site2</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site3</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Clinical Site4</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Clinical Site</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyama Clinical Site</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Clinical Site</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamagata Clinical Site</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Busan Clinical Site1</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Busan Clinical Site2</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Busan Clinical Site3</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Clinical Site1</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Clinical Site2</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Clinical Site3</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daejeon Clinical Site 1</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daejeon Clinical Site 2</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gwangju Clinical Site</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeonggi-do Clinical Site1</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeonggi-do Clinical Site2</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeonggi-do Clinical Site3</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeonggi-do Clinical Site4</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeonggi-do Clinical Site5</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeollabuk-do Clinical Site</name>
      <address>
        <city>Jeollabuk-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site 8</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site 9</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site1</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site2</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site3</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site4</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site5</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site6</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site7</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Clinical Site2</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Clinical Site</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Taipei Clinical Site</name>
      <address>
        <city>New Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Clinical Site</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tainan Clinical Site2</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tainan Clinical Site</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Clinical Site1</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Clinical Site2</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Tegafur</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_url>https://www.ono-pharma.com/en/company/policies/clinical_trial_data_transparency_policy.html</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03006705
org study id: ONO-4538-38
nct id: NCT03006705
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant
      chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1
      therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in
      combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including
      esophagogastric junction cancer) after D2 or more extensive lymph node dissection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Relapse-free survival (RFS)
time frame: 5 years
measure: Overall survival (OS)
time frame: 5 years
measure: 3-year OS rate
time frame: 3 years
measure: 5-year OS rate
time frame: 5 years
measure: 3-year RFS rate
time frame: 3 years
measure: 5-year RFS rate
time frame: 5 years
measure: Safety will be analyzed through the incidence of adverse events, serious adverse events
time frame: Up to 28 days from last dose
measure: Safety will be analyzed through the incidence of laboratory abnormalities
time frame: Up to 28 days from last dose
arm group label: Nivolumab group
arm group type: Experimental
description: Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.
S-1 therapy(maximum 1 year):
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
CapeOX Therapy(maximum 6 months):
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.
S-1 therapy(maximum 1 year):
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
CapeOX Therapy(maximum 6 months):
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
arm group label: Nivolumab group
other name: BMS-936558
other name: ONO-4538
other name: MDX-1106
intervention type: Drug
intervention name: Tegafur-gimeracil-oteracil potassium
description: Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
arm group label: Nivolumab group
arm group label: Placebo group
intervention type: Drug
intervention name: Oxaliplatin
description: Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
arm group label: Nivolumab group
arm group label: Placebo group
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
arm group label: Nivolumab group
arm group label: Placebo group
intervention type: Drug
intervention name: Placebo
description: Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
arm group label: Placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Project Leader
role: Study Director
affiliation: Ono Pharmaceutical Co. Ltd
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country: China
country: Japan
country: Korea, Republic of
country: Taiwan
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Capecitabine
mesh term: Tegafur
mesh term: Oxaliplatin
mesh term: Nivolumab
sharing ipd: Yes
ipd url: https://www.ono-pharma.com/en/company/policies/clinical_trial_data_transparency_policy.html