<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/NCT02213289</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-0141</org_study_id>
    <nct_id>NCT02213289</nct_id>
  </id_info>
  <brief_title>PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression</brief_title>
  <official_title>PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if doctors can use the results of special tests of&#xD;
      subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a&#xD;
      specific drug that is targeted to work against that abnormality (called molecular profiling)&#xD;
      and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it&#xD;
      is given with standard chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2015</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>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>Overall Survival</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>Time from enrollment to death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Biopsies Leading to an Adverse Event</measure>
    <time_frame>1 Month</time_frame>
    <description>Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of Biopsy and Successful, Molecularly-based Treatment Assignment</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event From Serial Biopsy for Second-line Treatment</measure>
    <time_frame>Up to 60 Months</time_frame>
    <description>Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event From Serial Biopsy for Third-line Treatment</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>First-line Progression-free Survival</measure>
    <time_frame>Up to 60 Months</time_frame>
    <description>Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Objective Response to First Line Therapy</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology included PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (HER2 amplified)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HER2 amplified. These patients received standard cytotherapy plus Trastuzumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (EFGR amplified)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR amplified. These patients received ABT-806.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (EGFR expressing)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR expressing. These patients received standard cytotherapy plus ABT 806.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (All negative)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All negative. These patients received standard cytotherapy plus Ramucirumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ITT: Standard Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients without monoclonal antibodies available received standard cytotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Trastuzumab</description>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (HER2 amplified)</arm_group_label>
    <other_name>Herceptin®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-806</intervention_name>
    <description>ABT-806</description>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (EFGR amplified)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (EGFR expressing)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bemarituzumab</intervention_name>
    <description>Bemarituzumab</description>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramucirumab</intervention_name>
    <description>Ramucirumab</description>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (All negative)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)</arm_group_label>
    <other_name>Cyramza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab</description>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard cytotherapy</intervention_name>
    <description>FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (All negative)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (EFGR amplified)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (EGFR expressing)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (HER2 amplified)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)</arm_group_label>
    <arm_group_label>ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)</arm_group_label>
    <arm_group_label>Non-ITT: Standard Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III&#xD;
             Siewert) adenocarcinoma&#xD;
&#xD;
          2. Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery&#xD;
&#xD;
               -  &gt;6 months after completion of adjuvant therapy (including chemotherapy and/or&#xD;
                  radiotherapy)&#xD;
&#xD;
               -  No prior treatment with any targeted agent&#xD;
&#xD;
               -  Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2&#xD;
                  amplified tumors) may be considered for trial participation if they have received&#xD;
                  no more than 4 doses of therapy at the time of consent and screening.&#xD;
&#xD;
          3. Measurable metastatic disease by RECIST criteria,&#xD;
&#xD;
               -  Must be amenable to ultrasound or CT-guided biopsy of one metastatic lesion&#xD;
&#xD;
               -  Peritoneal disease as the sole site of occult metastasis or presenting as&#xD;
                  malignant ascites is acceptable if a cell block of tumor cells can be obtained&#xD;
                  showing &gt;20% viable tumor cells.&#xD;
&#xD;
          4. ECOG PS 0,1&#xD;
&#xD;
          5. Age &gt; 18 years&#xD;
&#xD;
          6. Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  granulocytes &gt;1,2500/mcL&#xD;
&#xD;
               -  platelets &gt;100,000/mcL&#xD;
&#xD;
               -  total bilirubin &lt; 1.5 x ULN, &lt;1.8 x ULN with liver metastases&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) &lt;2.5 X ULN without liver metastases; &lt;5 X ULN with liver&#xD;
                  metastases&#xD;
&#xD;
               -  creatinine within normal institutional limits (&lt;1.5) OR&#xD;
&#xD;
               -  creatinine clearance &gt;50 mL/min/1.73m2, (for creatinine level above normal)&#xD;
&#xD;
               -  INR: &lt; 1.5 (patients on warfarin need to be converted to LMWH during study&#xD;
                  participation to be eligible)&#xD;
&#xD;
          7. Consent to baseline metastatic and progressive disease biopsy (of&#xD;
             metastatic/progressing lesion) for enabling biomarker assessment and treatment&#xD;
             assignment (at each time point - baseline, PD1, PD2, PD3) as well as for correlative&#xD;
             studies.&#xD;
&#xD;
             • Consent to baseline and serial blood draws for plasma/serum/whole blood banking for&#xD;
             correlative studies&#xD;
&#xD;
          8. Ability to understand and the willingness to sign a written informed consent document&#xD;
             and consent to the serial nature of the proposed PANGEA treatment with first, second&#xD;
             and third line therapy as tolerated.&#xD;
&#xD;
          9. Ability to comply with requirements of the protocol, as assessed by the investigator&#xD;
             by the patient signing the consent form.&#xD;
&#xD;
         10. If history of exposure to anthracyclines during perioperative treatment, the following&#xD;
             cumulative doses of anthracyclines must be less than:&#xD;
&#xD;
             Epirubicin &lt; 720 mg/m2 Doxorubicin or liposomal doxorubicin &lt; 360 mg/m2 Mitoxantrone &gt;&#xD;
             120 mg/m2 and idarubicin &gt; 90 mg/m2 If more than one anthracycline has been used, then&#xD;
             the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.&#xD;
&#xD;
         11. Cardiac Ejection Fraction &gt;50% (for HER2+ patients) as assessed by echocardiogram,&#xD;
             MUGA scan, or cardiac MRI&#xD;
&#xD;
         12. Willingness to use effective and reliable methods of contraception (For appropriate&#xD;
             methods of contraception considered acceptable see Appendix B).&#xD;
&#xD;
        Both men and women and members of all races and ethnic groups are eligible for this trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No CVA within 6 months, no recent MI within 6 months&#xD;
&#xD;
          2. No currently active second malignancy&#xD;
&#xD;
          3. No uncontrolled intercurrent illness or infection&#xD;
&#xD;
          4. No peripheral edema &gt; grade 2 at baseline.&#xD;
&#xD;
          5. No peripheral neuropathy &gt; grade 2 at baseline.&#xD;
&#xD;
          6. No diarrhea &gt; grade 2 at baseline.&#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>Daniel Catenacci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>January 29, 2021</results_first_submitted>
  <results_first_submitted_qc>March 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 8, 2021</results_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric</keyword>
  <keyword>Esophagogastric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Bemarituzumab</mesh_term>
    <mesh_term>Ramucirumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT02213289/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ITT-PTS: Personalized Treatment Strategy</title>
          <description>For patients with monoclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus Trastuzumab.&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.&#xD;
Of note, while the protocol section describes these tailored therapies, the efficacy evaluation was based on pooling these treatments into a combined &quot;personalized treatment strategy&quot; group and comparing with historical controls. Therefore this &quot;arm&quot; includes all such patients with monoclonal antibodies available.</description>
        </group>
        <group group_id="P2">
          <title>Non-ITT: Standard Therapy</title>
          <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)&#xD;
Of note, this arm includes patients without monoclonal antibodies available, for whom no personalized treatment strategy was available. The intent of the protocol was NOT to compare this arm with arm 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Immuno-oncology</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>HER2 Amplified</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>EGFR Amplified</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>FGFR2 Amplified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>MAPK/PIK3CA Aberrant</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>EGFR Expressing</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>All Negative</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Other (Non-ITT)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ITT-PTS: Personalized Treatment Strategy</title>
          <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive patients received standard cytoptherapy plus Nivolumab&#xD;
HER2 amplified patients received standard cytotherapy plus Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
        </group>
        <group group_id="B2">
          <title>Non-ITT: Standard Therapy</title>
          <description>For patients without monoclonal antibodies available, therapy was standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" lower_limit="28" upper_limit="81"/>
                    <measurement group_id="B2" value="61" lower_limit="39" upper_limit="77"/>
                    <measurement group_id="B3" value="61" lower_limit="28" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival</title>
        <description>Time from enrollment to death from any cause.</description>
        <time_frame>Up to 60 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Time from enrollment to death from any cause.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" lower_limit="13.4" upper_limit="17.7"/>
                    <measurement group_id="O2" value="9.0" lower_limit="4.6" upper_limit="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0024</p_value>
            <method>One-sided Z-test</method>
            <method_desc>This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Biopsies Leading to an Adverse Event</title>
        <description>Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).</description>
        <time_frame>1 Month</time_frame>
        <population>Unit of analysis is the biopsy. Each patient had two biopsies, one of the primary tumor and one of a metastatic site.</population>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Biopsies Leading to an Adverse Event</title>
          <description>Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).</description>
          <population>Unit of analysis is the biopsy. Each patient had two biopsies, one of the primary tumor and one of a metastatic site.</population>
          <units>biopsies</units>
          <param>Number</param>
          <units_analyzed>Biopsies</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Biopsies</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Completion of Biopsy and Successful, Molecularly-based Treatment Assignment</title>
        <description>Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
        <time_frame>Up to 1 month</time_frame>
        <population>Unit of analysis is the biopsy. Two biopsies were performed per patient, one of the primary tumor and one from a metastatic site.</population>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Completion of Biopsy and Successful, Molecularly-based Treatment Assignment</title>
          <description>Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
          <population>Unit of analysis is the biopsy. Two biopsies were performed per patient, one of the primary tumor and one from a metastatic site.</population>
          <units>biopsies</units>
          <param>Number</param>
          <units_analyzed>Biopsies</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Biopsies</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Event From Serial Biopsy for Second-line Treatment</title>
        <description>Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)</description>
        <time_frame>Up to 60 Months</time_frame>
        <population>This includes subset of patients administered second-line treatment</population>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Event From Serial Biopsy for Second-line Treatment</title>
          <description>Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)</description>
          <population>This includes subset of patients administered second-line treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment</title>
        <description>Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
        <time_frame>Up to 60 months</time_frame>
        <population>This includes subset of patients administered second-line treatment</population>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment</title>
          <description>Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
          <population>This includes subset of patients administered second-line treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Event From Serial Biopsy for Third-line Treatment</title>
        <description>Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)</description>
        <time_frame>Up to 60 months</time_frame>
        <population>This includes subset of patients administered third-line treatment</population>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patient including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806.&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Event From Serial Biopsy for Third-line Treatment</title>
          <description>Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)</description>
          <population>This includes subset of patients administered third-line treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment</title>
        <description>Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
        <time_frame>Up to 60 months</time_frame>
        <population>This includes subset of patients administered third-line treatment</population>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus received Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plous ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment</title>
          <description>Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).</description>
          <population>This includes subset of patients administered third-line treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>First-line Progression-free Survival</title>
        <description>Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
        <time_frame>Up to 60 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus Trastuzumab&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>First-line Progression-free Survival</title>
          <description>Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" lower_limit="7.3" upper_limit="9.6"/>
                    <measurement group_id="O2" value="6.7" lower_limit="2.9" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Objective Response to First Line Therapy</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</description>
        <time_frame>Up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ITT-PTS: Personalized Treatment Strategy</title>
            <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus Trastuzumab.&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806.&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
          </group>
          <group group_id="O2">
            <title>Non-ITT: Standard Therapy</title>
            <description>For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response to First Line Therapy</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>60 months</time_frame>
      <desc>Molecular arms/groups are combined for this analysis because the intent of the study was to compare the overall strategy of molecular-based treatment vs. not undertaking molecular-based therapy. Thus the number of patients with adverse events over the potential three lines of therapy is reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>ITT-PTS: Personalized Treatment Strategy</title>
          <description>For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:&#xD;
Immuno-oncology patients including PD-L1 IHC combined positivity score &gt;10, high microsatellite instability, tumor mutation burden &gt;15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.&#xD;
HER2 amplified patients received standard cytotherapy plus Trastuzumab.&#xD;
EGFR amplified patients received standard cytotherapy plus ABT-806..&#xD;
FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.&#xD;
MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.&#xD;
EGFR expressing patients received standard cytotherapy plus ABT 806.&#xD;
All negative patients received standard cytotherapy plus Ramucirumab.</description>
        </group>
        <group group_id="E2">
          <title>Non-ITT: Standard Therapy</title>
          <description>For patients without monoclonal antibodies available.These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood and lymphatic system disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Esophageal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Esophageal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pelvic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Phlebitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain - cardiac</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distenstion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspepsia/heartburn</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dysphagia, esophagitis, odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastroesophagial reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>hemorrhoidal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Intra-abdominal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary track infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Platelet count decreases</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified - Other</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizzines</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Neuropathy-sensory</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hallucinations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Mood aleration - depression</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia synrome</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Daniel Catenacci, MD</name_or_title>
      <organization>University of Chicago</organization>
      <phone>2-1000</phone>
      <email>dcatenac@bsd.uchicago.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02213289
org study id: IRB14-0141
nct id: NCT02213289
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if doctors can use the results of special tests of
      subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a
      specific drug that is targeted to work against that abnormality (called molecular profiling)
      and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it
      is given with standard chemotherapy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: Up to 60 months
description: Time from enrollment to death from any cause.
measure: Number of Biopsies Leading to an Adverse Event
time frame: 1 Month
description: Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).
measure: Completion of Biopsy and Successful, Molecularly-based Treatment Assignment
time frame: Up to 1 month
description: Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).
measure: Adverse Event From Serial Biopsy for Second-line Treatment
time frame: Up to 60 Months
description: Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
measure: Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment
time frame: Up to 60 months
description: Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).
measure: Adverse Event From Serial Biopsy for Third-line Treatment
time frame: Up to 60 months
description: Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
measure: Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment
time frame: Up to 60 months
description: Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).
measure: First-line Progression-free Survival
time frame: Up to 60 Months
description: Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
measure: Objective Response to First Line Therapy
time frame: Up to 6 months
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
arm group label: ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)
arm group type: Experimental
description: For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:
Immuno-oncology included PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab.
arm group label: ITT-PTS: Personalized Treatment Strategy (HER2 amplified)
arm group type: Experimental
description: HER2 amplified. These patients received standard cytotherapy plus Trastuzumab.
arm group label: ITT-PTS: Personalized Treatment Strategy (EFGR amplified)
arm group type: Experimental
description: EGFR amplified. These patients received ABT-806.
arm group label: ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)
arm group type: Experimental
description: FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab.
arm group label: ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)
arm group type: Experimental
description: MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab.
arm group label: ITT-PTS: Personalized Treatment Strategy (EGFR expressing)
arm group type: Experimental
description: EGFR expressing. These patients received standard cytotherapy plus ABT 806.
arm group label: ITT-PTS: Personalized Treatment Strategy (All negative)
arm group type: Experimental
description: All negative. These patients received standard cytotherapy plus Ramucirumab.
arm group label: Non-ITT: Standard Therapy
arm group type: Other
description: Patients without monoclonal antibodies available received standard cytotherapy.
intervention type: Drug
intervention name: Trastuzumab
description: Trastuzumab
arm group label: ITT-PTS: Personalized Treatment Strategy (HER2 amplified)
other name: Herceptin®
intervention type: Drug
intervention name: ABT-806
description: ABT-806
arm group label: ITT-PTS: Personalized Treatment Strategy (EFGR amplified)
arm group label: ITT-PTS: Personalized Treatment Strategy (EGFR expressing)
intervention type: Drug
intervention name: Bemarituzumab
description: Bemarituzumab
arm group label: ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)
intervention type: Drug
intervention name: Ramucirumab
description: Ramucirumab
arm group label: ITT-PTS: Personalized Treatment Strategy (All negative)
arm group label: ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)
other name: Cyramza
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab
arm group label: ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)
other name: Opdivo
intervention type: Drug
intervention name: Standard cytotherapy
description: FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
arm group label: ITT-PTS: Personalized Treatment Strategy (All negative)
arm group label: ITT-PTS: Personalized Treatment Strategy (EFGR amplified)
arm group label: ITT-PTS: Personalized Treatment Strategy (EGFR expressing)
arm group label: ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)
arm group label: ITT-PTS: Personalized Treatment Strategy (HER2 amplified)
arm group label: ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)
arm group label: ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)
arm group label: Non-ITT: Standard Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Catenacci, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Nivolumab
mesh term: Trastuzumab
mesh term: Bemarituzumab
mesh term: Ramucirumab
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 