<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/NCT02999295</url>
  </required_header>
  <id_info>
    <org_study_id>NCCH-1611</org_study_id>
    <nct_id>NCT02999295</nct_id>
  </id_info>
  <brief_title>A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer</brief_title>
  <official_title>A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Japan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fiverings Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cancer Center, Japan</source>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the safety and efficacy of the combination&#xD;
      therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable&#xD;
      gastric or GEJ cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with dose limiting toxicities (DLTs)</measure>
    <time_frame>Phase 1, course 1 (up to 28 days)</time_frame>
    <description>Number of participants with dose limiting toxicities (DLTs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression free survival rate after 6 months</measure>
    <time_frame>from baseline to 6 months</time_frame>
    <description>Progression free survival rate after 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>from baseline to date of treatment cessation, approximately 24 months</time_frame>
    <description>Number of participants with adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>from baseline to date of disease progression, approximately 24 months</time_frame>
    <description>percentage of participants with with a best response of complete response (CR) or partial response (PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>from baseline to date of disease progression, approximately 24 months</time_frame>
    <description>percentage of participants with with a best response of CR, PR or stable disease (SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>from baseline to date of death, approximately 24 months</time_frame>
    <description>Overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>from baseline to date of disease progression or death, approximately 24 months</time_frame>
    <description>Progression free survival (PFS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Gastroesophageal Junction Region (GEJ) Cancer</condition>
  <arm_group>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ramucirumab</intervention_name>
    <description>Ramucirumab (8 mg/kg) is administered.</description>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_label>Phase 2</arm_group_label>
    <other_name>LY3009806</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.</description>
    <arm_group_label>Phase 1</arm_group_label>
    <arm_group_label>Phase 2</arm_group_label>
    <other_name>ONO-4538</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced or recurrent unresectable gastric or GEJ cancer&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular&#xD;
             adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma,&#xD;
             mucinous adenocarcinoma or hepatoid adnocarcinoma&#xD;
&#xD;
          -  Patients with normal oral intake&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Patients who have measurable target lesion&#xD;
&#xD;
          -  Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer&#xD;
             agent and platinum-based anticancer agent&#xD;
&#xD;
          -  Patients with adequate organ function&#xD;
&#xD;
          -  Patients with no pretreatment history including ramucirumab, nivolumab or other&#xD;
             therapies targeting control of T cells&#xD;
&#xD;
          -  Patients with written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients have double cancer&#xD;
&#xD;
          -  Patients have infection required systemic therapy&#xD;
&#xD;
          -  Known central vervous system (CNS) metastasis&#xD;
&#xD;
          -  Patients with history of pneumonitis or pulmonary fibrosis&#xD;
&#xD;
          -  Patients with history of serious anaphylaxis induced by antibody preparation&#xD;
&#xD;
          -  Patients who have known active autoimmune disease or history of chronic recurrent&#xD;
             autoimmune disease&#xD;
&#xD;
          -  Female who is pregnant, lactating or suspected pregnancy&#xD;
&#xD;
          -  Patients with psychosis or dementia to interfere to obtain informed consent&#xD;
             appropriately&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ken Kato, M.D. / Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Gastrointestinal Medical Oncology, National cancer center hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Japan</investigator_affiliation>
    <investigator_full_name>Ken Kato</investigator_full_name>
    <investigator_title>Head Physician</investigator_title>
  </responsible_party>
  <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>Nivolumab</mesh_term>
    <mesh_term>Ramucirumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02999295
org study id: NCCH-1611
nct id: NCT02999295
lead sponsor: 
collaborator: 
collaborator: 
The main purpose of this study is to evaluate the safety and efficacy of the combination
      therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable
      gastric or GEJ cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose limiting toxicities (DLTs)
time frame: Phase 1, course 1 (up to 28 days)
description: Number of participants with dose limiting toxicities (DLTs)
measure: Progression free survival rate after 6 months
time frame: from baseline to 6 months
description: Progression free survival rate after 6 months
measure: Number of participants with adverse events
time frame: from baseline to date of treatment cessation, approximately 24 months
description: Number of participants with adverse events
measure: Objective response rate (ORR)
time frame: from baseline to date of disease progression, approximately 24 months
description: percentage of participants with with a best response of complete response (CR) or partial response (PR)
measure: Disease control rate (DCR)
time frame: from baseline to date of disease progression, approximately 24 months
description: percentage of participants with with a best response of CR, PR or stable disease (SD)
measure: Overall survival (OS)
time frame: from baseline to date of death, approximately 24 months
description: Overall survival (OS)
measure: Progression free survival (PFS)
time frame: from baseline to date of disease progression or death, approximately 24 months
description: Progression free survival (PFS)
arm group label: Phase 1
arm group type: Experimental
description: Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
arm group label: Phase 2
arm group type: Experimental
description: Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
intervention type: Biological
intervention name: Ramucirumab
description: Ramucirumab (8 mg/kg) is administered.
arm group label: Phase 1
arm group label: Phase 2
other name: LY3009806
intervention type: Biological
intervention name: Nivolumab
description: Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
arm group label: Phase 1
arm group label: Phase 2
other name: ONO-4538
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ken Kato, M.D. / Ph.D.
role: Principal Investigator
affiliation: Department of Gastrointestinal Medical Oncology, National cancer center hospital
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Japan
investigator full name: Ken Kato
investigator title: Head Physician
mesh term: Stomach Neoplasms
mesh term: Nivolumab
mesh term: Ramucirumab