<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/NCT02982720</url>
  </required_header>
  <id_info>
    <org_study_id>GI16-263</org_study_id>
    <nct_id>NCT02982720</nct_id>
  </id_info>
  <brief_title>Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron</brief_title>
  <official_title>A Phase II Multi-center Study Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and Sylatron (Peginterferon Alfa-2b) HCRN:GI16-263</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aiwu Ruth He, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hoosier Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoosier Cancer Research Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-arm, multicenter Phase II safety and efficacy study of&#xD;
      combination therapy with pembrolizumab and Sylatron (Peginterferon alpha-2b) in patients with&#xD;
      advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pembrolizumab and Sylatron Administration:&#xD;
&#xD;
      Pembrolizumab has been evaluated at 2 mg/kg every 3 weeks (Q3W), 10 mg/kg Q3W, or 10 mg/kg&#xD;
      Q2W in multiple previous studies for different types of cancer, the response rate at higher&#xD;
      dose level seems not improved compared to that of lower dose level. With concerns of&#xD;
      increased toxicities from the combination pembrolizumab and sylatron therapy, the&#xD;
      pembrolizumab dose is selected to be 200mg administered every three weeks. The approved dose&#xD;
      of sylatron for melanoma is induction treatment at 6 μg/kg/week for 8 doses followed by 5&#xD;
      year of maintenance treatment at 3 μg/kg/week for up to 5 years. The approved dose of&#xD;
      sylatron for chronic hepatitis C infection in combination with ribavirin is 1.5μg/kg weekly&#xD;
      for 24 to 48 weeks.&#xD;
&#xD;
      Each cycle = 21 days or 3 weeks. Based on the approved dosage of sylatron, we decided to&#xD;
      treat patients at 200mcg weekly up to 12 weeks (3 weeks as single agent, and 9 weeks in&#xD;
      combination of pembrolizumab). Sylatron will start Cycle 1 Day 1 and continue on a weekly&#xD;
      basis. We have prepared to reduce the dose of sylatron to 120mcg weekly, or 60mcg weekly if&#xD;
      patients experience unacceptable toxicities at the higher dose level of sylatron.&#xD;
&#xD;
      Pembrolizumab will be administered intravenously as a 30 minute infusion at a dose of 200 mg&#xD;
      every 3 weeks starting Week 4. Pembrolizumab will start Cycle 2 Day 1 and continue every 3&#xD;
      weeks. All trial treatments will be administered on an outpatient basis.&#xD;
&#xD;
      Sites should make every effort to target infusion timing to be as close to 30 minutes as&#xD;
      possible. However, given the variability of infusion pumps from site to site, a window of -5&#xD;
      minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).&#xD;
&#xD;
      With concerns about toxicity while using long-term sylatron, if no additional benefit is seen&#xD;
      beyond 12 weeks of treatment on top of that expected from pembrolizumab alone, patients will&#xD;
      discontinue sylatron treatment after they have received 12 weeks of this therapy (3 weeks as&#xD;
      single agent and 9 weeks in combination with pembrolizumab). Pembrolizumab should be&#xD;
      continued in the absence of unacceptable toxicity (based on CTCAE v4) until disease&#xD;
      progression-based on RECIST 1.1. In patients who had responded to the combination therapy,&#xD;
      when patient shows disease progression while on single agent pembrolizumab treatment,&#xD;
      Sylatron may be resumed at the discretion of the site investigator after discussion with the&#xD;
      sponsor-investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Manufacturer discontinued Sylatron&#xD;
  </why_stopped>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">February 9, 2018</completion_date>
  <primary_completion_date type="Actual">February 9, 2018</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>
    <masking_description>Open-Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Asses Objective Response Rate (ORR) of All Patients Receiving Pembrolizumab and Sylatron Combination Therapy</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess Progression Free Survival (PFS) of Patients Receiving Pembrolizumab and Sylatron</measure>
    <time_frame>36 months</time_frame>
    <description>Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asses Overall Survival (OS) of Patients Receiving Pembrolizumab and Sylatron</measure>
    <time_frame>36 months</time_frame>
    <description>Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Objective Response Rate (ORR)</measure>
    <time_frame>36 months</time_frame>
    <description>the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Adverse Events, Serious Adverse Events and Serious Adverse Events Leading to Discontinuation of the Treatment (Death) of Combined Pembrolizumab and Sylatron Therapy.</measure>
    <time_frame>36 months</time_frame>
    <description>the combination of Sylatron and pembrolizumab as assessed by CTCAE v4</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Advanced Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab and Sylatron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab will be administered intravenously.</description>
    <arm_group_label>Pembrolizumab and Sylatron</arm_group_label>
    <other_name>MK-3475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sylatron</intervention_name>
    <description>Sylatron will be administered subcutaneously.</description>
    <arm_group_label>Pembrolizumab and Sylatron</arm_group_label>
    <other_name>Peginterferon alfa-2b</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subject must meet all of the following applicable inclusion criteria to participate in this&#xD;
        study:&#xD;
&#xD;
          1. Be willing and able to provide written informed consent/assent for the trial.&#xD;
&#xD;
          2. Be at least 18 years of age on day of signing informed consent.&#xD;
&#xD;
          3. Patients must have received 1 line of prior systemic therapy for metastatic or&#xD;
             resectable disease (i.e. patients may have received adjuvant gemcitabine and then&#xD;
             later gemcitabine/cisplatin for recurrent metastatic disease)&#xD;
&#xD;
          4. Histological confirmation of cholangiocarcinoma.&#xD;
&#xD;
          5. Have measurable disease based on RECIST 1.1.&#xD;
&#xD;
          6. Be willing to provide tissue from a newly obtained core or excisional biopsy of a&#xD;
             tumor lesion. Newly obtained is defined as a specimen obtained up to 6 weeks (42 days)&#xD;
             prior to initiation of treatment on Day 1. Subjects for whom newly obtained samples&#xD;
             cannot be provided (e.g. inaccessible or subject safety concern) may submit an&#xD;
             archived specimen only upon agreement from the sponsor-investigator.&#xD;
&#xD;
          7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             Performance Scale.&#xD;
&#xD;
          8. Demonstrate adequate organ function:&#xD;
&#xD;
             Hematological:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500 /μL&#xD;
&#xD;
               -  Platelets ≥ 100,000 / μL&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within&#xD;
                  7 days of assessment)&#xD;
&#xD;
             Renal:&#xD;
&#xD;
               -  Serum creatinine OR Measured or calculated creatinine clearance ≤ 1.5 X upper&#xD;
                  limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels&#xD;
&#xD;
               -  (GFR can also be used in place of creatinine or CrCl) &gt; 1.5 x institutional ULN&#xD;
&#xD;
             Hepatic:&#xD;
&#xD;
               -  Serum total bilirubin ≤ 2.0 X ULN&#xD;
&#xD;
               -  AST (SGOT) and ALT (SGPT) ≤ 3.0 X ULN OR ≤ 5 X ULN for subjects with liver&#xD;
                  metastases&#xD;
&#xD;
               -  Albumin &gt; 2.5 mg/dL&#xD;
&#xD;
             Coagulation:&#xD;
&#xD;
               -  International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 X ULN unless&#xD;
                  subject is receiving anticoagulant therapy as long as PT or PTT is within&#xD;
                  therapeutic range of intended use of anticoagulants&#xD;
&#xD;
               -  Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 X ULN unless subject is&#xD;
                  receiving anticoagulant therapy as long as PT or PTT is within therapeutic range&#xD;
                  of intended use of anticoagulants&#xD;
&#xD;
          9. Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy within 72 hours prior to receiving the first dose of study medication. If&#xD;
             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test&#xD;
             will be required.&#xD;
&#xD;
         10. Female subjects of childbearing potential should be willing to use adequate birth&#xD;
             control or be surgically sterile, or abstain from heterosexual activity for the course&#xD;
             of the study through 120 days after the last dose of study medication. Subjects of&#xD;
             childbearing potential are those who have not been surgically sterilized or have not&#xD;
             been free from menses for &gt; 1 year.&#xD;
&#xD;
         11. Male subjects should agree to use an adequate method of contraception starting with&#xD;
             the first dose of study therapy through 120 days after the last dose of study therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The subject must be excluded from participating in the trial if the subject:&#xD;
&#xD;
          1. A history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b&#xD;
&#xD;
          2. Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigational&#xD;
             device within 4 weeks of the first dose of treatment.&#xD;
&#xD;
          3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             treatment.&#xD;
&#xD;
          4. Has a known history of active Bacillus Tuberculosis (TB)&#xD;
&#xD;
          5. Hypersensitivity to pembrolizumab or any of its excipients.&#xD;
&#xD;
          6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study&#xD;
             Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events&#xD;
             due to agents administered more than 4 weeks earlier.&#xD;
&#xD;
          7. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy&#xD;
             within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at&#xD;
             baseline) from adverse events due to a previously administered agent.&#xD;
&#xD;
               -  Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and&#xD;
                  may qualify for the study.&#xD;
&#xD;
               -  Note: If subject received major surgery, they must have recovered adequately from&#xD;
                  the toxicity and/or complications from the intervention prior to starting&#xD;
                  therapy.&#xD;
&#xD;
          8. Has a known additional malignancy that is progressing or requires active treatment.&#xD;
             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
             skin that has undergone potentially curative therapy or in situ cervical cancer.&#xD;
&#xD;
          9. Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis. Subjects with previously treated brain metastases may participate provided&#xD;
             they are stable (without evidence of progression by imaging for at least four weeks&#xD;
             prior to the first dose of trial treatment and any neurologic symptoms have returned&#xD;
             to baseline), have no evidence of new or enlarging brain metastases, and are not using&#xD;
             steroids for at least 7 days prior to trial treatment. This exception does not include&#xD;
             carcinomatous meningitis, which is excluded regardless of clinical stability.&#xD;
&#xD;
         10. Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive&#xD;
             drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment.&#xD;
&#xD;
         11. Has known history of, or any evidence of active, non-infectious pneumonitis.&#xD;
&#xD;
         12. Has an active infection requiring systemic therapy.&#xD;
&#xD;
         13. Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the trial, interfere with the subject's&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the site investigator.&#xD;
&#xD;
         14. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
         15. Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment.&#xD;
&#xD;
         16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.&#xD;
&#xD;
         17. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
         18. Has known active Hepatitis B without HBV treatment (HBV infection with ongoing HBV&#xD;
             treatment is allowed); has persistent chronic Hepatitis C infection (successfully&#xD;
             treated HCV infection is allowed).&#xD;
&#xD;
         19. Has received a live vaccine within 30 days of planned start of study therapy. Note:&#xD;
             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and&#xD;
             are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live&#xD;
             attenuated vaccines, and are not allowed.&#xD;
&#xD;
         20. Has history of bipolar disorder or major depression.&#xD;
&#xD;
         21. Has history of not tolerating interferon treatment.&#xD;
&#xD;
         22. Has known serious neuropsychiatric condition.&#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>Aiwu R. He, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Lombardi Comprehensive Cancer Center Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown Lombardi Comprehensive Cancer Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.hoosiercancer.org</url>
    <description>Hoosier Cancer Research Network Website</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>May 16, 2019</results_first_submitted>
  <results_first_submitted_qc>May 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 5, 2019</results_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hoosier Cancer Research Network</investigator_affiliation>
    <investigator_full_name>Aiwu Ruth He, MD</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>cholangiocarcinoma</keyword>
  <keyword>Pembrolizumab</keyword>
  <keyword>MK-3475</keyword>
  <keyword>Sylatron</keyword>
  <keyword>peginterferon alfa-2b</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peginterferon alfa-2b</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>December 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT02982720/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab and Sylatron</title>
          <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab and Sylatron</title>
          <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.5" lower_limit="64" upper_limit="73"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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>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="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="3"/>
                  </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="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Subtype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Extrahepatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gallbladder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hilum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intrahepatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Asses Objective Response Rate (ORR) of All Patients Receiving Pembrolizumab and Sylatron Combination Therapy</title>
        <description>Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1</description>
        <time_frame>12 months</time_frame>
        <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab and Sylatron</title>
            <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
          </group>
        </group_list>
        <measure>
          <title>Asses Objective Response Rate (ORR) of All Patients Receiving Pembrolizumab and Sylatron Combination Therapy</title>
          <description>Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1</description>
          <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Progression Free Survival (PFS) of Patients Receiving Pembrolizumab and Sylatron</title>
        <description>Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).</description>
        <time_frame>36 months</time_frame>
        <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab and Sylatron</title>
            <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Progression Free Survival (PFS) of Patients Receiving Pembrolizumab and Sylatron</title>
          <description>Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).</description>
          <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asses Overall Survival (OS) of Patients Receiving Pembrolizumab and Sylatron</title>
        <description>Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).</description>
        <time_frame>36 months</time_frame>
        <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab and Sylatron</title>
            <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
          </group>
        </group_list>
        <measure>
          <title>Asses Overall Survival (OS) of Patients Receiving Pembrolizumab and Sylatron</title>
          <description>Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).</description>
          <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Objective Response Rate (ORR)</title>
        <description>the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.</description>
        <time_frame>36 months</time_frame>
        <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab and Sylatron</title>
            <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Objective Response Rate (ORR)</title>
          <description>the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.</description>
          <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Adverse Events, Serious Adverse Events and Serious Adverse Events Leading to Discontinuation of the Treatment (Death) of Combined Pembrolizumab and Sylatron Therapy.</title>
        <description>the combination of Sylatron and pembrolizumab as assessed by CTCAE v4</description>
        <time_frame>36 months</time_frame>
        <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab and Sylatron</title>
            <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Adverse Events, Serious Adverse Events and Serious Adverse Events Leading to Discontinuation of the Treatment (Death) of Combined Pembrolizumab and Sylatron Therapy.</title>
          <description>the combination of Sylatron and pembrolizumab as assessed by CTCAE v4</description>
          <population>No data was collected or analyzed for this objective due to the early termination of the study by the funder.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab and Sylatron</title>
          <description>Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.&#xD;
Pembrolizumab: Pembrolizumab will be administered intravenously.&#xD;
Sylatron: Sylatron will be administered subcutaneously.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAEv4</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FEVER</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAEv4</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
              </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="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ENDOCRINE DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>HYPERTHYROIDISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>BLURRED VISION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>GLAUCOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>DIARRHEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ANOREXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>HYPERGLYCEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINEMIA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>HYPOPHOSPHATEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </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="4"/>
              </event>
              <event>
                <sub_title>SKIN AND SUBCUTANEOUS TISSUE DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </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>
    <limitations_and_caveats>This study was terminated by the funder due to the discontinuation of Sylatron.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinicaltrials.gov Results Coordinator</name_or_title>
      <organization>Hoosier Cancer Research Network</organization>
      <phone>317.921.2050</phone>
      <email>jsmith@hoosiercancer.org</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/NCT02982720
org study id: GI16-263
nct id: NCT02982720
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, single-arm, multicenter Phase II safety and efficacy study of
      combination therapy with pembrolizumab and Sylatron (Peginterferon alpha-2b) in patients with
      advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline chemotherapy.
Pembrolizumab and Sylatron Administration:

      Pembrolizumab has been evaluated at 2 mg/kg every 3 weeks (Q3W), 10 mg/kg Q3W, or 10 mg/kg
      Q2W in multiple previous studies for different types of cancer, the response rate at higher
      dose level seems not improved compared to that of lower dose level. With concerns of
      increased toxicities from the combination pembrolizumab and sylatron therapy, the
      pembrolizumab dose is selected to be 200mg administered every three weeks. The approved dose
      of sylatron for melanoma is induction treatment at 6 μg/kg/week for 8 doses followed by 5
      year of maintenance treatment at 3 μg/kg/week for up to 5 years. The approved dose of
      sylatron for chronic hepatitis C infection in combination with ribavirin is 1.5μg/kg weekly
      for 24 to 48 weeks.

      Each cycle = 21 days or 3 weeks. Based on the approved dosage of sylatron, we decided to
      treat patients at 200mcg weekly up to 12 weeks (3 weeks as single agent, and 9 weeks in
      combination of pembrolizumab). Sylatron will start Cycle 1 Day 1 and continue on a weekly
      basis. We have prepared to reduce the dose of sylatron to 120mcg weekly, or 60mcg weekly if
      patients experience unacceptable toxicities at the higher dose level of sylatron.

      Pembrolizumab will be administered intravenously as a 30 minute infusion at a dose of 200 mg
      every 3 weeks starting Week 4. Pembrolizumab will start Cycle 2 Day 1 and continue every 3
      weeks. All trial treatments will be administered on an outpatient basis.

      Sites should make every effort to target infusion timing to be as close to 30 minutes as
      possible. However, given the variability of infusion pumps from site to site, a window of -5
      minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).

      With concerns about toxicity while using long-term sylatron, if no additional benefit is seen
      beyond 12 weeks of treatment on top of that expected from pembrolizumab alone, patients will
      discontinue sylatron treatment after they have received 12 weeks of this therapy (3 weeks as
      single agent and 9 weeks in combination with pembrolizumab). Pembrolizumab should be
      continued in the absence of unacceptable toxicity (based on CTCAE v4) until disease
      progression-based on RECIST 1.1. In patients who had responded to the combination therapy,
      when patient shows disease progression while on single agent pembrolizumab treatment,
      Sylatron may be resumed at the discretion of the site investigator after discussion with the
      sponsor-investigator.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open-Label
measure: Asses Objective Response Rate (ORR) of All Patients Receiving Pembrolizumab and Sylatron Combination Therapy
time frame: 12 months
description: Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1
measure: Assess Progression Free Survival (PFS) of Patients Receiving Pembrolizumab and Sylatron
time frame: 36 months
description: Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).
measure: Asses Overall Survival (OS) of Patients Receiving Pembrolizumab and Sylatron
time frame: 36 months
description: Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).
measure: Assess Objective Response Rate (ORR)
time frame: 36 months
description: the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.
measure: Assess Adverse Events, Serious Adverse Events and Serious Adverse Events Leading to Discontinuation of the Treatment (Death) of Combined Pembrolizumab and Sylatron Therapy.
time frame: 36 months
description: the combination of Sylatron and pembrolizumab as assessed by CTCAE v4
arm group label: Pembrolizumab and Sylatron
arm group type: Experimental
description: Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab will be administered intravenously.
arm group label: Pembrolizumab and Sylatron
other name: MK-3475
intervention type: Drug
intervention name: Sylatron
description: Sylatron will be administered subcutaneously.
arm group label: Pembrolizumab and Sylatron
other name: Peginterferon alfa-2b
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aiwu R. He, MD PhD
role: Study Chair
affiliation: Lombardi Comprehensive Cancer Center Georgetown University
facility: 
country: United States
url: http://www.hoosiercancer.org
description: Hoosier Cancer Research Network Website
responsible party type: Sponsor-Investigator
investigator affiliation: Hoosier Cancer Research Network
investigator full name: Aiwu Ruth He, MD
investigator title: Sponsor-Investigator
mesh term: Cholangiocarcinoma
mesh term: Peginterferon alfa-2b
mesh term: Pembrolizumab
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated by the funder due to the discontinuation of Sylatron.
point of contact: 