<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/NCT03264404</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR3554</org_study_id>
    <nct_id>NCT03264404</nct_id>
  </id_info>
  <brief_title>Azacitidine and Pembrolizumab in Pancreatic Cancer</brief_title>
  <official_title>Phase II Open-Label, Single-Center Study Evaluating Safety and Efficacy of Pembrolizumab Following Induction With the Hypomethylating Agent Azacitidine in Patients With Advanced Pancreatic Cancer After Failure of First-Line Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruth A. White, MD, PhD.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of combining immune therapy,&#xD;
      pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who&#xD;
      have advanced pancreatic cancer with disease progression on first-line therapy are usually&#xD;
      treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy&#xD;
      regimen and national guidelines recommend chemotherapy or clinical trial participation. In&#xD;
      this study, all study subjects will receive a combination of immune therapy (every 3 weeks)&#xD;
      and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a&#xD;
      hypomethylating agent with chemotherapy or immune therapy may benefit patients across&#xD;
      different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of&#xD;
      pancreatic cancer demonstrates improvement in survival with the combination of a&#xD;
      hypomethylating agent and immune therapy. However, the use of single agent hypomethylating&#xD;
      agent or immune therapy has not been shown to be effective in patients with pancreatic&#xD;
      cancer. The one exception, to date, is the use of immune therapy in those individuals with a&#xD;
      particular genetic feature known as mismatch repair deficiency and microsatellite&#xD;
      instability. The combination of immune therapy and a hypomethylating agent has not been&#xD;
      studied in human subjects and is not approved by the FDA for use in pancreatic cancer.&#xD;
&#xD;
      This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in&#xD;
      subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31&#xD;
      individuals will be asked to participate in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any major malignancy in the&#xD;
      United States and, unlike other common cancers, annual deaths from PDA are rising. Despite&#xD;
      recent advances, cytotoxic chemotherapy for PDA has been disappointing. Even among the small&#xD;
      subset of patients who are suitable for surgical resection at the time of diagnosis, complete&#xD;
      resection is followed by recurrence in majority of patients without further systemic therapy.&#xD;
      Thus all PDA patients require systemic chemotherapy and more effective regimens are urgently&#xD;
      needed.&#xD;
&#xD;
      Combination chemotherapy is effective in controlling disease and prolonging survival in&#xD;
      patients with advanced pancreatic cancer. Despite recent successful phase 3 studies in the&#xD;
      first-line setting, there is no defined second-line treatment for patients who experience&#xD;
      disease progression following first-line therapy. Consensus guidelines (such as the National&#xD;
      Comprehensive Cancer Network (NCCN) guidelines) recommend clinical trial participation in&#xD;
      this setting.&#xD;
&#xD;
      The investigators' pre-clinical data suggests that decitabine treatment in the KPC model of&#xD;
      pancreatic cancer leads to a significant up-regulation of interferon-related genes and a&#xD;
      polarization of the infiltrating immune cells. Based on these results, the investigators have&#xD;
      evaluated the effect of single agent decitabine or anti-PD1H (a homologue of PD1 with very&#xD;
      similar function and expression pattern) compared to combination therapy (treatment with&#xD;
      decitabine followed by PD1H blockade). The investigators' preliminary results showed minimal&#xD;
      effect of either agent alone on tumor growth but marked decrease in tumor progression in the&#xD;
      combination arm. These results form the foundation of this phase II study.&#xD;
&#xD;
      This study will treat patients with the combination of azacitidine and pembrolizumab. A&#xD;
      direct comparison between azacitidine and decitabine in terms of efficacy within a controlled&#xD;
      clinical trial has not been performed thus far. In randomized myelodysplastic syndrome (MDS)&#xD;
      trials, the remission rates were similar for azacitidine and decitabine but the overall&#xD;
      survival in the experimental arm was significantly shorter in the decitabine trial compared&#xD;
      to the azacitidine trial. A primary reason to utilize azacitidine in this setting is our&#xD;
      desire to amply reduced dose therapy with the goal of maintaining subjects on therapy&#xD;
      Low-dose azacitidine is being tested in phase I/II clinical trials for advanced solid&#xD;
      tumors-mainly colorectal cancer, small-cell lung carcinomas, ovarian cancer, and breast&#xD;
      cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>24 months</time_frame>
    <description>PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)) or death due to any cause, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>24 months</time_frame>
    <description>ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>24 months</time_frame>
    <description>For subjects who demonstrate CR or PR, based on assessments per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>24 months</time_frame>
    <description>DCR is defined as the percentage of subjects who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Pancreas Cancer</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab 200 mg IV every 3 weeks until progression</description>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <other_name>Keytruda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>50 mg/m2 subcutaneous daily for 5 days every 28 days</description>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <other_name>Vidaza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing and able to provide written informed consent for the trial.&#xD;
&#xD;
          -  Age ≥18 years of age on day of signing informed consent.&#xD;
&#xD;
          -  Have confirmed diagnosis of pancreatic ductal adenocarcinoma&#xD;
&#xD;
          -  Have a predicted life expectancy of greater than 3 months.&#xD;
&#xD;
          -  Have measurable disease based on RECIST 1.1.&#xD;
&#xD;
          -  Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group&#xD;
             (ECOG) Performance Scale within 3 days of first dose of study drug.&#xD;
&#xD;
          -  Have documented radiographic progression to or documented intolerance of first line&#xD;
             systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU) based&#xD;
             regimen (including capecitabine).&#xD;
&#xD;
          -  Subjects who have documented disease recurrence within 6 months of completing&#xD;
             neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for study.&#xD;
             Subjects who recur greater than 6 months after completing adjuvant or neoadjuvant&#xD;
             chemotherapy will not be eligible unless they receive additional chemotherapy for&#xD;
             advanced disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy, or herbal/complementary oral&#xD;
             or IV medicine within 2 weeks of the first dose of treatment.&#xD;
&#xD;
          -  Has received chemotherapy or radiotherapy within 14 days of first dose of study&#xD;
             medication.&#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>Ruth White, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>June 8, 2023</results_first_submitted>
  <results_first_submitted_qc>July 1, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2023</results_first_posted>
  <last_update_submitted>July 1, 2023</last_update_submitted>
  <last_update_submitted_qc>July 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Ruth A. White, MD, PhD.</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Pancreas</keyword>
  <keyword>pembrolizumab</keyword>
  <keyword>azacitidine</keyword>
  <keyword>metastatic pancreatic cancer</keyword>
  <keyword>first-line</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Azacitidine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03264404/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab</title>
          <description>Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.&#xD;
Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks until progression&#xD;
Azacitidine: 50 mg/m2 subcutaneous daily for 5 days every 28 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Off study prior to treatment</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab</title>
          <description>Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.&#xD;
Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks until progression&#xD;
Azacitidine: 50 mg/m2 subcutaneous daily for 5 days every 28 days</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="64.3" spread="9.79"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)) or death due to any cause, whichever occurs first.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab</title>
            <description>Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.&#xD;
Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks until progression&#xD;
Azacitidine: 50 mg/m2 subcutaneous daily for 5 days every 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)) or death due to any cause, whichever occurs first.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.</description>
        <time_frame>24 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>For subjects who demonstrate CR or PR, based on assessments per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.</description>
        <time_frame>24 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR)</title>
        <description>DCR is defined as the percentage of subjects who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.</description>
        <time_frame>24 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab</title>
          <description>Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.&#xD;
Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks until progression&#xD;
Azacitidine: 50 mg/m2 subcutaneous daily for 5 days every 28 days</description>
        </group>
      </group_list>
      <serious_events>
        <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="26" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="36"/>
              </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="4" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hepatic hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </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="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="36" subjects_at_risk="36"/>
              </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="10" subjects_affected="4" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear and labyrinth disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Endocrine disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Watering eyes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="21" subjects_affected="13" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Anal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Edema, Limbs</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Portal hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning and procedural complications</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increase</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>International Normalized Ratio (INR) Increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Creatinine Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="17" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cardiac troponin T increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hallucinations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal dryness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </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="8" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ruth White, MD, PhD</name_or_title>
      <organization>Columbia University</organization>
      <phone>212-342-5162</phone>
      <email>raw2168@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264404
org study id: AAAR3554
nct id: NCT03264404
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to determine the effectiveness of combining immune therapy,
      pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who
      have advanced pancreatic cancer with disease progression on first-line therapy are usually
      treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy
      regimen and national guidelines recommend chemotherapy or clinical trial participation. In
      this study, all study subjects will receive a combination of immune therapy (every 3 weeks)
      and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a
      hypomethylating agent with chemotherapy or immune therapy may benefit patients across
      different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of
      pancreatic cancer demonstrates improvement in survival with the combination of a
      hypomethylating agent and immune therapy. However, the use of single agent hypomethylating
      agent or immune therapy has not been shown to be effective in patients with pancreatic
      cancer. The one exception, to date, is the use of immune therapy in those individuals with a
      particular genetic feature known as mismatch repair deficiency and microsatellite
      instability. The combination of immune therapy and a hypomethylating agent has not been
      studied in human subjects and is not approved by the FDA for use in pancreatic cancer.

      This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in
      subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31
      individuals will be asked to participate in this study.
Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any major malignancy in the
      United States and, unlike other common cancers, annual deaths from PDA are rising. Despite
      recent advances, cytotoxic chemotherapy for PDA has been disappointing. Even among the small
      subset of patients who are suitable for surgical resection at the time of diagnosis, complete
      resection is followed by recurrence in majority of patients without further systemic therapy.
      Thus all PDA patients require systemic chemotherapy and more effective regimens are urgently
      needed.

      Combination chemotherapy is effective in controlling disease and prolonging survival in
      patients with advanced pancreatic cancer. Despite recent successful phase 3 studies in the
      first-line setting, there is no defined second-line treatment for patients who experience
      disease progression following first-line therapy. Consensus guidelines (such as the National
      Comprehensive Cancer Network (NCCN) guidelines) recommend clinical trial participation in
      this setting.

      The investigators' pre-clinical data suggests that decitabine treatment in the KPC model of
      pancreatic cancer leads to a significant up-regulation of interferon-related genes and a
      polarization of the infiltrating immune cells. Based on these results, the investigators have
      evaluated the effect of single agent decitabine or anti-PD1H (a homologue of PD1 with very
      similar function and expression pattern) compared to combination therapy (treatment with
      decitabine followed by PD1H blockade). The investigators' preliminary results showed minimal
      effect of either agent alone on tumor growth but marked decrease in tumor progression in the
      combination arm. These results form the foundation of this phase II study.

      This study will treat patients with the combination of azacitidine and pembrolizumab. A
      direct comparison between azacitidine and decitabine in terms of efficacy within a controlled
      clinical trial has not been performed thus far. In randomized myelodysplastic syndrome (MDS)
      trials, the remission rates were similar for azacitidine and decitabine but the overall
      survival in the experimental arm was significantly shorter in the decitabine trial compared
      to the azacitidine trial. A primary reason to utilize azacitidine in this setting is our
      desire to amply reduced dose therapy with the goal of maintaining subjects on therapy
      Low-dose azacitidine is being tested in phase I/II clinical trials for advanced solid
      tumors-mainly colorectal cancer, small-cell lung carcinomas, ovarian cancer, and breast
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS)
time frame: 24 months
description: PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)) or death due to any cause, whichever occurs first.
measure: Objective Response Rate (ORR)
time frame: 24 months
description: ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
measure: Duration of Response (DOR)
time frame: 24 months
description: For subjects who demonstrate CR or PR, based on assessments per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
measure: Disease Control Rate (DCR)
time frame: 24 months
description: DCR is defined as the percentage of subjects who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.
arm group label: Pembrolizumab
arm group type: Experimental
description: Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab 200 mg IV every 3 weeks until progression
arm group label: Pembrolizumab
other name: Keytruda
intervention type: Drug
intervention name: Azacitidine
description: 50 mg/m2 subcutaneous daily for 5 days every 28 days
arm group label: Pembrolizumab
other name: Vidaza
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruth White, MD, PhD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Columbia University
investigator full name: Ruth A. White, MD, PhD.
investigator title: Assistant Professor of Medicine
mesh term: Pancreatic Neoplasms
mesh term: Pembrolizumab
mesh term: Azacitidine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 