<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/NCT03036098</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-901</org_study_id>
    <secondary_id>2016-003881-14</secondary_id>
    <nct_id>NCT03036098</nct_id>
  </id_info>
  <brief_title>Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer</brief_title>
  <acronym>CheckMate901</acronym>
  <official_title>A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether an investigational immunotherapy nivolumab&#xD;
      in combination with ipilimumab or in combination with standard of care chemotherapy is more&#xD;
      effective than standard of care chemotherapy alone in treating participants with previously&#xD;
      untreated inoperable or metastatic urothelial cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 24, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS) in cisplatin-ineligible randomized participants</measure>
    <time_frame>Up to 55 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS) in PD-L1 positive (&gt;=1%) randomized participants by immunohistochemistry (IHC)</measure>
    <time_frame>Up to 52 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC</measure>
    <time_frame>Up to 64 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC</measure>
    <time_frame>Up to 64 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) in all randomized participants</measure>
    <time_frame>Up to 55 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants</measure>
    <time_frame>Up to 55 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants</measure>
    <time_frame>Up to 55 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants</measure>
    <time_frame>Up to 55 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants</measure>
    <time_frame>Up to 55 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC</measure>
    <time_frame>Up to 64 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) by BICR by PD-L1 expression at &gt;=1% by immunohistochemistry (IHC)</measure>
    <time_frame>Up to 64 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)</measure>
    <time_frame>Up to 64 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1290</enrollment>
  <condition>Urothelial Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A: Investigational immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Standard of care chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: Investigational immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D: Standard of care chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm A: Investigational immunotherapy</arm_group_label>
    <arm_group_label>Arm C: Investigational immunotherapy</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm A: Investigational immunotherapy</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm B: Standard of care chemotherapy</arm_group_label>
    <arm_group_label>Arm C: Investigational immunotherapy</arm_group_label>
    <arm_group_label>Arm D: Standard of care chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm B: Standard of care chemotherapy</arm_group_label>
    <arm_group_label>Arm C: Investigational immunotherapy</arm_group_label>
    <arm_group_label>Arm D: Standard of care chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Arm B: Standard of care chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological evidence of metastatic or surgically inoperable&#xD;
             transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter,&#xD;
             bladder or urethra&#xD;
&#xD;
          -  No prior systemic chemotherapy for metastatic or surgically inoperable urothelial&#xD;
             cancer (UC)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1&#xD;
&#xD;
          -  Women and men must agree to follow specific methods of contraception, if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease that is suitable for local therapy administered with curative intent&#xD;
&#xD;
          -  Any serious or uncontrolled medical disorder in the opinion of the investigator that&#xD;
             may increase the risk associated with study participation or study drug administration&#xD;
             or interfere with the interpretation of study results&#xD;
&#xD;
          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4&#xD;
             antibody, or any other antibody or drug specifically targeting T-cell co-stimulation&#xD;
             or checkpoint pathways&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alaska Urological Institute dba Alaska Clinical Research Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0115</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Joseph Heritage Healthcare</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0051</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0087</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0062</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0004</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0033</name>
      <address>
        <city>Thomasville</city>
        <state>Georgia</state>
        <zip>31792</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0046</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Local Institution - 0117</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0056</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0073</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0208</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0207</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <zip>01757</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0063</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
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    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Burnsville</city>
        <state>Minnesota</state>
        <zip>55337</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
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      <name>Local Institution - 0032</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111-3220</zip>
        <country>United States</country>
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      <name>Local Institution - 0095</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0057</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
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    <facility>
      <name>Local Institution - 0083</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
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    </facility>
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    <facility>
      <name>Local Institution - 0014</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
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    <facility>
      <name>Local Institution - 0072</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
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    <facility>
      <name>Local Institution - 0116</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
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      <name>Local Institution - 0082</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
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    <facility>
      <name>Local Institution - 0104</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Local Institution - 0013</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0086</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0005</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1426</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0007</name>
      <address>
        <city>Mar Del Plata</city>
        <state>Buenos Aires</state>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Viedma</city>
        <state>RIO Negro</state>
        <zip>8500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1120</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0134</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Cordoba</city>
        <zip>5004</zip>
        <country>Argentina</country>
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    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0096</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0099</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0188</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0120</name>
      <address>
        <city>Tugun</city>
        <state>Queensland</state>
        <zip>4224</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0101</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0100</name>
      <address>
        <city>Doubleview</city>
        <state>Western Australia</state>
        <zip>6018</zip>
        <country>Australia</country>
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  <location>
    <facility>
      <name>Local Institution - 0017</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>70200-730</zip>
        <country>Brazil</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0021</name>
      <address>
        <city>Ijui</city>
        <state>RIO Grande DO SUL</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0119</name>
      <address>
        <city>Passo Fundo</city>
        <state>RIO Grande DO SUL</state>
        <zip>99010-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0020</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90610000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0016</name>
      <address>
        <city>Florianopolis</city>
        <state>Santa Catarina</state>
        <zip>88034-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0018</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0019</name>
      <address>
        <city>Sao Jose Do Rio Preto</city>
        <state>Sao Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0053</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0064</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
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    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0054</name>
      <address>
        <city>Quebec</city>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Vina del Mar</city>
        <state>Valparaiso</state>
        <zip>2520598</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0106</name>
      <address>
        <city>Vitacura</city>
        <zip>0</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0171</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0169</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0182</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0219</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0180</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0177</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0176</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0175</name>
      <address>
        <city>Nanjng</city>
        <state>Jiangsu</state>
        <zip>0</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0186</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0220</name>
      <address>
        <city>Taiyuan</city>
        <state>Shan1xi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0216</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>264000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0167</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0162</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0163</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0184</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0174</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0172</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0173</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0170</name>
      <address>
        <city>Beijing</city>
        <zip>100083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0164</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0160</name>
      <address>
        <city>Brno</city>
        <zip>656 53</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0152</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0190</name>
      <address>
        <city>Aalborg</city>
        <zip>9210</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0196</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0060</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0089</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0088</name>
      <address>
        <city>Marseille Cedex 9</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0091</name>
      <address>
        <city>Nimes Cedex 09</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0090</name>
      <address>
        <city>St Priest En Jarez</city>
        <zip>42271</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0092</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0093</name>
      <address>
        <city>Tours Cedex</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0094</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0036</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0048</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0047</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0049</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0037</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0041</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0213</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0038</name>
      <address>
        <city>Nuernberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0040</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0114</name>
      <address>
        <city>Weiden</city>
        <zip>92637</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0039</name>
      <address>
        <city>Wuerzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0102</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0103</name>
      <address>
        <city>Ioannina</city>
        <state>Ípeiros</state>
        <zip>455 00</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0199</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0198</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0108</name>
      <address>
        <city>Arezzo</city>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0197</name>
      <address>
        <city>Faenza</city>
        <zip>48018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0111</name>
      <address>
        <city>Forlì</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0109</name>
      <address>
        <city>Grosseto</city>
        <zip>58100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0107</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0110</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0136</name>
      <address>
        <city>Hirosaki-shi</city>
        <state>Aomori</state>
        <zip>036-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0135</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0147</name>
      <address>
        <city>Matsuyama-shi</city>
        <state>Ehime</state>
        <zip>7910280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0140</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>8128582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0146</name>
      <address>
        <city>Sapporo-city</city>
        <state>Hokkaido</state>
        <zip>0608543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0150</name>
      <address>
        <city>Tsukuba-shi</city>
        <state>Ibaraki</state>
        <zip>3058576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0214</name>
      <address>
        <city>Morioka-shi</city>
        <state>Iwate</state>
        <zip>0208505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0137</name>
      <address>
        <city>Kita-Gun</city>
        <state>Kagawa</state>
        <zip>7610793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0141</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>9518520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0143</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>7008558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0144</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>5418567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0139</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0145</name>
      <address>
        <city>Takatsuki-shi</city>
        <state>Osaka</state>
        <zip>5698686</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0201</name>
      <address>
        <city>Hamamatasu</city>
        <state>Shizuoka</state>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0149</name>
      <address>
        <city>Adachi-ku</city>
        <state>Tokyo</state>
        <zip>1168567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0148</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0142</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0138</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>1608582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0215</name>
      <address>
        <city>Wakayama-shi</city>
        <state>Wakayama</state>
        <zip>641-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0200</name>
      <address>
        <city>Ube City</city>
        <state>Yamaguchi</state>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0125</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggido</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0126</name>
      <address>
        <city>Seongnam-si</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0124</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0151</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0128</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0127</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0129</name>
      <address>
        <city>Ciudad de Mexico</city>
        <state>Distrito Federal</state>
        <zip>06100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0154</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>07760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0130</name>
      <address>
        <city>Tlalpan</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0131</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
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    <facility>
      <name>Local Institution - 0055</name>
      <address>
        <city>Enschede</city>
        <zip>7512KZ</zip>
        <country>Netherlands</country>
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    <facility>
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        <zip>9713 GZ</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
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    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0074</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
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  </location>
  <location>
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        <city>Lorenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Lima</city>
        <zip>34</zip>
        <country>Peru</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
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        <city>Lima</city>
        <zip>Lima 27</zip>
        <country>Peru</country>
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    <facility>
      <name>Local Institution - 0189</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0205</name>
      <address>
        <city>Koszalin</city>
        <zip>75-581</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Local Institution - 0202</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0191</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0187</name>
      <address>
        <city>Craiova</city>
        <zip>200542</zip>
        <country>Romania</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>125367</zip>
        <country>Russian Federation</country>
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    <facility>
      <name>Local Institution - 0192</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
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  <location>
    <facility>
      <name>Local Institution - 0070</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Local Institution - 0068</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0065</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0066</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0209</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0067</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0069</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0075</name>
      <address>
        <city>Jonkoping</city>
        <zip>553 05</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0059</name>
      <address>
        <city>Linkoping</city>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0058</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0061</name>
      <address>
        <city>Baden</city>
        <zip>5404</zip>
        <country>Switzerland</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0042</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0156</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
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  </location>
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    <facility>
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      <address>
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        <zip>40705</zip>
        <country>Taiwan</country>
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      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
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        <zip>11217</zip>
        <country>Taiwan</country>
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  </location>
  <location>
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        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
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  </location>
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    <facility>
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      <address>
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        <zip>06590</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0204</name>
      <address>
        <city>Istanbul</city>
        <zip>34300</zip>
        <country>Turkey</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0193</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Hungary</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>http://www.BMSStudyConnect.com</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>http://www.fda.gov/safety/medwatch/safetyinformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</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/NCT03036098
org study id: CA209-901
secondary id: 2016-003881-14
nct id: NCT03036098
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine whether an investigational immunotherapy nivolumab
      in combination with ipilimumab or in combination with standard of care chemotherapy is more
      effective than standard of care chemotherapy alone in treating participants with previously
      untreated inoperable or metastatic urothelial cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS) in cisplatin-ineligible randomized participants
time frame: Up to 55 months
measure: Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)
time frame: Up to 52 months
measure: Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
time frame: Up to 64 months
measure: Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
time frame: Up to 64 months
measure: Overall survival (OS) in all randomized participants
time frame: Up to 55 months
measure: Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants
time frame: Up to 55 months
measure: Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants
time frame: Up to 55 months
measure: Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants
time frame: Up to 55 months
measure: European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
time frame: Up to 55 months
measure: European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC
time frame: Up to 64 months
measure: Progression-free survival (PFS) by BICR by PD-L1 expression at >=1% by immunohistochemistry (IHC)
time frame: Up to 64 months
measure: Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)
time frame: Up to 64 months
arm group label: Arm A: Investigational immunotherapy
arm group type: Experimental
arm group label: Arm B: Standard of care chemotherapy
arm group type: Active Comparator
arm group label: Arm C: Investigational immunotherapy
arm group type: Experimental
arm group label: Arm D: Standard of care chemotherapy
arm group type: Active Comparator
intervention type: Biological
intervention name: Nivolumab
description: Specified Dose on Specified Days
arm group label: Arm A: Investigational immunotherapy
arm group label: Arm C: Investigational immunotherapy
other name: BMS-936558
other name: Opdivo
intervention type: Biological
intervention name: Ipilimumab
description: Specified Dose on Specified Days
arm group label: Arm A: Investigational immunotherapy
other name: BMS-734016
other name: Yervoy
intervention type: Drug
intervention name: Gemcitabine
description: Specified Dose on Specified Days
arm group label: Arm B: Standard of care chemotherapy
arm group label: Arm C: Investigational immunotherapy
arm group label: Arm D: Standard of care chemotherapy
intervention type: Drug
intervention name: Cisplatin
description: Specified Dose on Specified Days
arm group label: Arm B: Standard of care chemotherapy
arm group label: Arm C: Investigational immunotherapy
arm group label: Arm D: Standard of care chemotherapy
intervention type: Drug
intervention name: Carboplatin
description: Specified Dose on Specified Days
arm group label: Arm B: Standard of care chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Australia
country: Brazil
country: Canada
country: Chile
country: China
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Norway
country: Peru
country: Poland
country: Romania
country: Russian Federation
country: Singapore
country: Spain
country: Sweden
country: Switzerland
country: Taiwan
country: Turkey
country: United States
country: Hungary
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: http://www.BMSStudyConnect.com
description: BMS Clinical Trial Patient Recruiting
url: http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Nivolumab
mesh term: Ipilimumab