<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/NCT03768531</url>
  </required_header>
  <id_info>
    <org_study_id>J18162</org_study_id>
    <secondary_id>IRB00185328</secondary_id>
    <nct_id>NCT03768531</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer</brief_title>
  <official_title>Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposed of this research is to study the safety and clinical activity of the combination&#xD;
      of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects were enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">June 14, 2019</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants experiencing study drug-related toxicities</measure>
    <time_frame>4 years</time_frame>
    <description>Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>4 years</time_frame>
    <description>Number of months from the date of first treatment until death or end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival (DFS)</measure>
    <time_frame>up to 4 years</time_frame>
    <description>Number of months until disease recurrence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Resectable Biliary Tract Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A: Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Nivolumab and Cabrilizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).</description>
    <arm_group_label>Arm A: Nivolumab</arm_group_label>
    <arm_group_label>Arm B: Nivolumab and Cabrilizumab</arm_group_label>
    <other_name>OPDIVO; BMS-936558-01</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabrilizumab</intervention_name>
    <description>Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).</description>
    <arm_group_label>Arm B: Nivolumab and Cabrilizumab</arm_group_label>
    <other_name>FPA008, BMS-986227</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has confirmed biliary tract cancer&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Have biopsiable disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Patient must have adequate organ function defined by the study-specified laboratory&#xD;
             tests.&#xD;
&#xD;
          -  Must use acceptable form of birth control while on study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has active autoimmune disease that requires systemic treatment.&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or has required active treatment&#xD;
             within the past 2 years or that is expected to require active treatment within two&#xD;
             years.&#xD;
&#xD;
          -  Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1,&#xD;
             anti-PD-L2, anti-CTLA4, etc.).&#xD;
&#xD;
          -  Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.&#xD;
&#xD;
          -  Has evidence of interstitial lung disease or active, non-infectious pneumonitis.&#xD;
&#xD;
          -  Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial,&#xD;
             anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study&#xD;
             medication.&#xD;
&#xD;
          -  Has received a blood transfusion within 72 hours prior to first dose of study drug&#xD;
             administration&#xD;
&#xD;
          -  Unwilling or unable to follow the study schedule for any reason.&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to initiation of study treatment.&#xD;
&#xD;
          -  Patient with uncontrolled intercurrent illness including, but not limited to,&#xD;
             uncontrolled infection, symptomatic congestive heart failure, unstable angina&#xD;
             pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements.&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Have known history of infection with HIV, hepatitis B, or hepatitis C.&#xD;
&#xD;
          -  Received any prophylactic vaccine within 30 days of first dose of study drug&#xD;
             treatment.&#xD;
&#xD;
          -  Has a history of allergy to study treatments or any of its components of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Murphy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Medical Institution</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nivolumab</keyword>
  <keyword>Cabiralizumab</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Anti-PD-1</keyword>
  <keyword>Anti-CSF-1R</keyword>
  <keyword>Biliary tract cancers (BTC)</keyword>
  <keyword>Neoadjuvant chemotherapy</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <keyword>Tumor microenvironment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03768531
org study id: J18162
secondary id: IRB00185328
nct id: NCT03768531
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purposed of this research is to study the safety and clinical activity of the combination
      of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants experiencing study drug-related toxicities
time frame: 4 years
description: Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0
measure: Overall survival (OS)
time frame: 4 years
description: Number of months from the date of first treatment until death or end of follow-up.
measure: Disease free survival (DFS)
time frame: up to 4 years
description: Number of months until disease recurrence.
arm group label: Arm A: Nivolumab
arm group type: Experimental
arm group label: Arm B: Nivolumab and Cabrilizumab
arm group type: Experimental
description: Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks).
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
arm group label: Arm A: Nivolumab
arm group label: Arm B: Nivolumab and Cabrilizumab
other name: OPDIVO; BMS-936558-01
intervention type: Drug
intervention name: Cabrilizumab
description: Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).
arm group label: Arm B: Nivolumab and Cabrilizumab
other name: FPA008, BMS-986227
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Adrian Murphy, MD
role: Principal Investigator
affiliation: Johns Hopkins Medical Institution
country: United States
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms
mesh term: Nivolumab
sharing ipd: No