<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/NCT03801915</url>
  </required_header>
  <id_info>
    <org_study_id>190039</org_study_id>
    <secondary_id>19-C-0039</secondary_id>
    <nct_id>NCT03801915</nct_id>
  </id_info>
  <brief_title>Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers</brief_title>
  <official_title>Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the&#xD;
      tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to&#xD;
      test how safe it is to give this agent to people before and after surgery to remove a tumor.&#xD;
      They want to learn the highest dose tolerated. They want to see if getting the agent at&#xD;
      surgery helps slow down the disease.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the&#xD;
      progression of the disease.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adults at least 18 years old with certain cancers and certain blood CA19-9 levels&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
        -  Medical history&#xD;
&#xD;
        -  Physical exam&#xD;
&#xD;
        -  Blood and heart tests&#xD;
&#xD;
        -  Scans&#xD;
&#xD;
        -  Review of normal activities&#xD;
&#xD;
        -  Review of tumor sample&#xD;
&#xD;
        -  Pregnancy test&#xD;
&#xD;
      A few days before surgery, participants will get a dose of the study agent. They will get it&#xD;
      through a small plastic tube in a vein over about 2 hours.&#xD;
&#xD;
      Participants will sign a separate consent and have the surgery. A sample of the tumor and&#xD;
      normal liver will be removed for research.&#xD;
&#xD;
      For 1-2 weeks after surgery, participants will recover in intensive care then regular care at&#xD;
      the hospital. They will be monitored and treated throughout the stay.&#xD;
&#xD;
      After leaving the hospital, participants will get the study agent every week for 1 month.&#xD;
      Then they will get it every other week for 2 months. They will repeat screening tests at&#xD;
      study visits and at a follow-up visit. That will be about 5 weeks after the last dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative,&#xD;
           and patients frequently succumb to disease recurrence in the ensuing months to year(s)&#xD;
           after the operation.&#xD;
&#xD;
        -  Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer&#xD;
           little demonstrable decreases in the rates of tumor recurrence.&#xD;
&#xD;
        -  The concept and implementation of immediate perioperative therapy has not been evaluated&#xD;
           given the serious concerns related to healing and recovery with standard cytotoxic&#xD;
           chemotherapy and newer targeted agents.&#xD;
&#xD;
        -  A significant percentage of metastatic colorectal cancers, and primary tumors of the&#xD;
           pancreas and bile ducts express Sialyl Lewis, an epitope on the well-established tumor&#xD;
           marker, Carbohydrate antigen 19-9 (CA19-9).&#xD;
&#xD;
        -  MVT-5873, a fully human antibody against Sialyl Lewis, has displayed antibody-dependent&#xD;
           cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro,&#xD;
           potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy in Phase&#xD;
           1 trials of patients with advanced inoperable Hepato-pancreato-biliary (HPB) cancers.&#xD;
&#xD;
        -  MVT-5873 is well tolerated as a single agent; moderate elevations in aspartate&#xD;
           aminotransferase (AST)/alanine aminotransferase (ALT) appear to be dose-limiting.&#xD;
&#xD;
        -  Patients with resectable Sialyl Lewis-expressing cancers represent an ideal population&#xD;
           to explore the use of perioperative MVT-5873 given moderate level of CA 19-9 elevations,&#xD;
           and the potential for extension of recurrence-free survival.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  Document the safety of perioperative MVT-5873 in patients undergoing pancreas and liver&#xD;
           resections.&#xD;
&#xD;
        -  Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for patients&#xD;
           with operable CA 19-9-producing cancers.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Histologically or cytologically confirmed adenocarcinoma of the&#xD;
&#xD;
             -  Colon (metastatic to liver)&#xD;
&#xD;
             -  Pancreas&#xD;
&#xD;
             -  Bile Ducts (Cholangiocarcinoma)&#xD;
&#xD;
        -  Serum CA19-9 levels greater than the upper limit of normal, but less than 2500.&#xD;
&#xD;
        -  Disease amenable to complete surgical extirpation.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      -Pre-operative one-time treatment with MVT-5873, resection to remove all demonstrable disease&#xD;
      in the liver, bile ducts and pancreas, and continuing MVT-5873 mono-therapy until off&#xD;
      treatment criteria are met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Actual">May 27, 2022</completion_date>
  <primary_completion_date type="Actual">May 27, 2022</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Disease Recurrence At 1 Year</measure>
    <time_frame>1 year</time_frame>
    <description>Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug</measure>
    <time_frame>Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.</time_frame>
    <description>Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873</measure>
    <time_frame>An average of 15.17 months</time_frame>
    <description>Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)</measure>
    <time_frame>Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.</time_frame>
    <description>Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Metastatic Colon Carcinoma</condition>
  <condition>Liver Metastasis</condition>
  <arm_group>
    <arm_group_label>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MVT-5873</intervention_name>
    <description>1 mg/kg or 3 mg/kg for pre-operative dose, 1 mg/kg during post-operative period</description>
    <arm_group_label>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</arm_group_label>
    <arm_group_label>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</arm_group_label>
    <other_name>HuMab-5B1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pancreatectomy or hepatectomy</intervention_name>
    <description>Pancreatectomy or hepatectomy</description>
    <arm_group_label>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</arm_group_label>
    <arm_group_label>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed diagnoses of&#xD;
             adenocarcinoma in one of the following scenarios:&#xD;
&#xD;
               -  Primary tumors of the pancreas&#xD;
&#xD;
               -  Primary tumors of the bile duct and ampulla&#xD;
&#xD;
               -  Metastatic colorectal cancers to the liver&#xD;
&#xD;
          -  Subjects must have disease resectable with a standard pancreatectomy&#xD;
             (pancreaticoduodenectomy or distal pancreatectomy) or liver resection.&#xD;
&#xD;
          -  Subjects may have received prior therapy, including neoadjuvant regimens.&#xD;
&#xD;
          -  Subjects must have serum Carbohydrate antigen 19-9 (CA 19-9) elevations greater than&#xD;
             the upper limit of normal but less than 2500 U/mL.&#xD;
&#xD;
          -  Age greater than or equal to 18 years.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1&#xD;
&#xD;
          -  Subjects must have adequate organ and marrow function as defined below:&#xD;
&#xD;
               -  leukocytes &gt;3,000/mcL&#xD;
&#xD;
               -  absolute neutrophil count &gt;1,500/mcL&#xD;
&#xD;
               -  platelets &gt;90,000/mcL&#xD;
&#xD;
          -  For subjects with Periampullary cancers that require a pancreaticoduodenectomy for&#xD;
             complete tumor extirpation:&#xD;
&#xD;
               -  total bilirubin &lt;10 upper limit of normal (ULN)*&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase&#xD;
                  (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase&#xD;
                  (SGPT) &lt;5 X institutional upper limit of normal&#xD;
&#xD;
               -  creatinine &lt;1.5X institutional upper limit of normal&#xD;
&#xD;
                    -  Subjects with periampullary cancers typically present with biliary&#xD;
                       obstruction resulting in significant abnormalities in liver function tests&#xD;
                       that do not reflect liver dysfunction. These values normalize after tumor&#xD;
                       removal. They can be normalized pre-operatively with biliary stenting, but&#xD;
                       several large studies have demonstrated an increase in infectious&#xD;
                       complications with drainage. As such, a practice standard has been to avoid&#xD;
                       stenting until bilirubin level rises above 10 X ULN.&#xD;
&#xD;
          -  For subjects with liver tumors (cholangiocarcinoma or metastatic colorectal cancer)&#xD;
             requiring a hepatectomy for complete tumor extirpation:&#xD;
&#xD;
               -  total bilirubin &lt;2.5 X institutional upper limit of normal*&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) &lt;5 X institutional upper limit of normal*&#xD;
&#xD;
               -  creatinine &lt;1.5X institutional upper limit of normal&#xD;
&#xD;
                    -  Liver abnormalities in this range are consistent with parenchymal&#xD;
                       destruction from the tumor.&#xD;
&#xD;
          -  For subjects with pancreas tumors that require a distal pancreatectomy for&#xD;
             extirpation:&#xD;
&#xD;
               -  total bilirubin &lt;1.5 X institutional upper limit of normal*&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) &lt;2 X institutional upper limit of normal*&#xD;
&#xD;
               -  creatinine &lt;1.5X institutional upper limit of normal&#xD;
&#xD;
                    -  Liver abnormalities in this range are consistent with pancreas cancer&#xD;
                       destruction from the tumor.&#xD;
&#xD;
          -  The effects of MVT-5873 (HuMab-5B1) on the developing human fetus are unknown. For&#xD;
             this reason, women of child-bearing potential and men must agree to use adequate&#xD;
             contraception (hormonal or barrier method of birth control; abstinence) prior to study&#xD;
             entry and for the duration of study participation and for 3 months after completion of&#xD;
             study treatment. Should a woman become pregnant or suspect she is pregnant while she&#xD;
             or her partner is participating in this study, she should inform her treating&#xD;
             physician immediately.&#xD;
&#xD;
          -  Ability of subject to understand and the willingness to sign a written informed&#xD;
             consent document.&#xD;
&#xD;
          -  Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor,&#xD;
             Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection&#xD;
             of Solid Tumors.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Presence of disease outside the confines of a standard operation for subjects with&#xD;
             periampullary cancers (pancreatic and cholangiocarcinoma).&#xD;
&#xD;
          -  Presence of disease outside the liver for subjects with intrahepatic/hilar&#xD;
             cholangiocarcinoma or metastatic colorectal cancer, other than a primary tumor for&#xD;
             subjects with metastatic colorectal cancer.&#xD;
&#xD;
          -  Subjects who are receiving any other investigational agents.&#xD;
&#xD;
          -  Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from&#xD;
             the last day of prior anticancer therapy, including chemotherapy, hormonal,&#xD;
             investigational, and or biological therapies and irradiation.&#xD;
&#xD;
          -  Uncontrolled inter-current illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study&#xD;
&#xD;
        requirements.&#xD;
&#xD;
        -Active concurrent malignancies within the last five years other than the primary tumor&#xD;
&#xD;
        in subjects with metastatic colorectal cancer, basal or squamous cell skin carcinoma or&#xD;
        non- medullary thyroid carcinoma.&#xD;
&#xD;
          -  Pregnant women are excluded from this study because of the potential for teratogenic&#xD;
             or abortifacient effects of the MVT-5873. Because there is an unknown but potential&#xD;
&#xD;
          -  Subjects with active, Hepatitis B or C infection because of the potential for&#xD;
             increased liver toxicity given the damaging effects of the virus.&#xD;
&#xD;
          -  Allergic to chimeric, humanized or human antibodies.&#xD;
&#xD;
          -  Received live vaccine within 4 weeks prior to first date of study intervention.&#xD;
&#xD;
          -  Infection requiring hospitalization or herpes zoster treatment within 2 weeks prior to&#xD;
             the first date of study intervention.&#xD;
&#xD;
          -  Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years&#xD;
             prior to the first date of study intervention.&#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>Jonathan M Hernandez, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-C-0039.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>February 27, 2023</results_first_submitted>
  <results_first_submitted_qc>February 27, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 21, 2023</results_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Institute (NCI)</investigator_affiliation>
    <investigator_full_name>Jonathan Hernandez, M.D.</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Well Tolerated Agent</keyword>
  <keyword>Pancreas and Liver Resections</keyword>
  <keyword>Recurrence-Free Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Clinical data available during the study and indefinitely. Genomic data is available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.</ipd_time_frame>
    <ipd_access_criteria>Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.</ipd_access_criteria>
  </patient_data>
  <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>August 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03801915/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03801915/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
          <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
          <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
        </group>
        <group group_id="P3">
          <title>Enrolled But Not Treated</title>
          <description>Enrolled But Not Treated</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ineligible</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One participant was enrolled but not treated. However, collected baseline data is reported here.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
          <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
          <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
        </group>
        <group group_id="B3">
          <title>Enrolled But Not Treated</title>
          <description>Enrolled But Not Treated</description>
        </group>
        <group group_id="B4">
          <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="8"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.75" spread="6.39"/>
                    <measurement group_id="B2" value="69.7" spread="0"/>
                    <measurement group_id="B3" value="48.8" spread="0"/>
                    <measurement group_id="B4" value="63.65" spread="7.84"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </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 group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Disease Recurrence At 1 Year</title>
        <description>Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease Recurrence At 1 Year</title>
          <description>Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.</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="8"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug</title>
        <description>Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.</description>
        <time_frame>Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug</title>
          <description>Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.</description>
          <units>Adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3 Abdominal pain - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Abdominal infection - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Alanine aminotransferase increased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Alkaline phosphatase increased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Anemia - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Aspartate aminotransferase increased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Back pain - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Blood bilirubin increased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Confusion - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Dyspnea - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hematuria - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hepatobiliary disorders- Other, Bile duct perforation - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hyperglycemia - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hypermagnesemia - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hypertension - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hypoalbuminemia - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hypokalemia - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hyponatremia - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Hypotension - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Lymphocyte count decreased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pharyngitis - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Thromboembolic event - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Urine output decreased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Vomiting - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Alkaline phosphatase increased - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Anemia - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Aspartate aminotransferase increased - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Alanine aminotransferase increased - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Blood bilirubin increased - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Lymphocyte count decreased - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Aspartate aminotransferase increased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Lymphocyte count increased - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Alkaline phosphatase increased - Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Adverse Event - Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Adverse Event - Related</title>
              <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>Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873</title>
        <description>Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug.</description>
        <time_frame>An average of 15.17 months</time_frame>
        <population>5/8 participants were analyzed in cohort 1 because 2 participants were found to have peritoneal metastases on Day 0 and were taken off study, and 1 participant was taken off study due to study closure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873</title>
          <description>Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug.</description>
          <population>5/8 participants were analyzed in cohort 1 because 2 participants were found to have peritoneal metastases on Day 0 and were taken off study, and 1 participant was taken off study due to study closure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="1" upper_limit="28"/>
                    <measurement group_id="O2" value="22" lower_limit="NA" upper_limit="NA">Full range cannot be calculated because the participant was taken off study due to study closure.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)</title>
        <description>Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
        <time_frame>Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
            <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)</title>
          <description>Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</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="8"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)</title>
          <description>Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)</title>
          <description>Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment&#xD;
MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period&#xD;
pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy&#xD;
Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (5.0)</default_vocab>
        <default_assessment>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="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders - Other, Bile duct perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (5.0)</default_vocab>
        <default_assessment>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="7" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" events="11" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" events="10" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="21" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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" events="3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="17" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymph leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Jonathan Hernandez</name_or_title>
      <organization>National Cancer Institute</organization>
      <phone>240-760-6072</phone>
      <email>jonathan.hernandez@nih.gov</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/NCT03801915
org study id: 190039
secondary id: 19-C-0039
nct id: NCT03801915
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Background:

      Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the
      tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to
      test how safe it is to give this agent to people before and after surgery to remove a tumor.
      They want to learn the highest dose tolerated. They want to see if getting the agent at
      surgery helps slow down the disease.

      Objective:

      To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the
      progression of the disease.

      Eligibility:

      Adults at least 18 years old with certain cancers and certain blood CA19-9 levels

      Design:

      Participants will be screened with:

        -  Medical history

        -  Physical exam

        -  Blood and heart tests

        -  Scans

        -  Review of normal activities

        -  Review of tumor sample

        -  Pregnancy test

      A few days before surgery, participants will get a dose of the study agent. They will get it
      through a small plastic tube in a vein over about 2 hours.

      Participants will sign a separate consent and have the surgery. A sample of the tumor and
      normal liver will be removed for research.

      For 1-2 weeks after surgery, participants will recover in intensive care then regular care at
      the hospital. They will be monitored and treated throughout the stay.

      After leaving the hospital, participants will get the study agent every week for 1 month.
      Then they will get it every other week for 2 months. They will repeat screening tests at
      study visits and at a follow-up visit. That will be about 5 weeks after the last dose.
Background:

        -  Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative,
           and patients frequently succumb to disease recurrence in the ensuing months to year(s)
           after the operation.

        -  Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer
           little demonstrable decreases in the rates of tumor recurrence.

        -  The concept and implementation of immediate perioperative therapy has not been evaluated
           given the serious concerns related to healing and recovery with standard cytotoxic
           chemotherapy and newer targeted agents.

        -  A significant percentage of metastatic colorectal cancers, and primary tumors of the
           pancreas and bile ducts express Sialyl Lewis, an epitope on the well-established tumor
           marker, Carbohydrate antigen 19-9 (CA19-9).

        -  MVT-5873, a fully human antibody against Sialyl Lewis, has displayed antibody-dependent
           cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro,
           potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy in Phase
           1 trials of patients with advanced inoperable Hepato-pancreato-biliary (HPB) cancers.

        -  MVT-5873 is well tolerated as a single agent; moderate elevations in aspartate
           aminotransferase (AST)/alanine aminotransferase (ALT) appear to be dose-limiting.

        -  Patients with resectable Sialyl Lewis-expressing cancers represent an ideal population
           to explore the use of perioperative MVT-5873 given moderate level of CA 19-9 elevations,
           and the potential for extension of recurrence-free survival.

      Objectives:

        -  Document the safety of perioperative MVT-5873 in patients undergoing pancreas and liver
           resections.

        -  Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for patients
           with operable CA 19-9-producing cancers.

      Eligibility:

        -  Histologically or cytologically confirmed adenocarcinoma of the

             -  Colon (metastatic to liver)

             -  Pancreas

             -  Bile Ducts (Cholangiocarcinoma)

        -  Serum CA19-9 levels greater than the upper limit of normal, but less than 2500.

        -  Disease amenable to complete surgical extirpation.

      Design:

      -Pre-operative one-time treatment with MVT-5873, resection to remove all demonstrable disease
      in the liver, bile ducts and pancreas, and continuing MVT-5873 mono-therapy until off
      treatment criteria are met.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Disease Recurrence At 1 Year
time frame: 1 year
description: Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.
measure: Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
time frame: Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
description: Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.
measure: Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873
time frame: An average of 15.17 months
description: Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug.
measure: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
time frame: Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
description: Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
arm group label: Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
arm group type: Experimental
description: Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
arm group label: Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
arm group type: Experimental
description: Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment
intervention type: Drug
intervention name: MVT-5873
description: 1 mg/kg or 3 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
arm group label: Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
arm group label: Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
other name: HuMab-5B1
intervention type: Procedure
intervention name: pancreatectomy or hepatectomy
description: Pancreatectomy or hepatectomy
arm group label: Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)
arm group label: Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan M Hernandez, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-C-0039.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Principal Investigator
investigator affiliation: National Cancer Institute (NCI)
investigator full name: Jonathan Hernandez, M.D.
investigator title: Investigator
mesh term: Pancreatic Neoplasms
mesh term: Cholangiocarcinoma
sharing ipd: Yes
ipd description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Clinical data available during the study and indefinitely. Genomic data is available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
ipd access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 