<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/NCT03818542</url>
  </required_header>
  <id_info>
    <org_study_id>M19-228</org_study_id>
    <nct_id>NCT03818542</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma</brief_title>
  <official_title>A Phase 1b Multi-Center Pharmacodynamic Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study&#xD;
      drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced&#xD;
      squamous cell carcinoma of the head and neck who are candidates for surgical resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic considerations&#xD;
  </why_stopped>
  <start_date type="Actual">January 22, 2020</start_date>
  <completion_date type="Actual">September 23, 2020</completion_date>
  <primary_completion_date type="Actual">September 23, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Gene Expression</measure>
    <time_frame>Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)</time_frame>
    <description>The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Study Drug</measure>
    <time_frame>Up to approximately 120 days</time_frame>
    <description>Maximum Serum Concentration (Cmax) of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Plasma Concentration (Tmax) of Study Drug</measure>
    <time_frame>Up to approximately 120 days</time_frame>
    <description>Time to Maximum Plasma Concentration (Tmax) of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve of Study Drug in Plasma</measure>
    <time_frame>Up to approximately 120 days</time_frame>
    <description>Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1: ABBV-181 IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: ABBV-368 IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3: ABBV-927 IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4: ABBV-927 IT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-181</intervention_name>
    <description>intravenous infusion</description>
    <arm_group_label>Arm 1: ABBV-181 IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-368</intervention_name>
    <description>intravenous infusion</description>
    <arm_group_label>Arm 2: ABBV-368 IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-927</intervention_name>
    <description>intravenous infusion</description>
    <arm_group_label>Arm 3: ABBV-927 IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-927</intervention_name>
    <description>intratumoral injection</description>
    <arm_group_label>Arm 4: ABBV-927 IT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed stage 3 to 4B squamous cell carcinoma of the oral cavity, oropharynx,&#xD;
             larynx, or hypopharynx who are candidates for surgical resection and are&#xD;
             treatment-naïve. Participants must have been determined to be candidates for surgical&#xD;
             resection by a multidisciplinary team including a surgeon, a medical oncologist, and a&#xD;
             radiation oncologist.&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 and life&#xD;
             expectancy of more than 3 months.&#xD;
&#xD;
          -  Must consent to provide the tumor tissues for analyses as described in the protocol.&#xD;
&#xD;
          -  Must have adequate bone marrow function (without any growth factors or transfusions&#xD;
             within 2 weeks prior to the first dose), kidney and liver function, with all&#xD;
             laboratory values criteria detailed in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received live vaccine within 28 days prior to the first dose of study drug.&#xD;
&#xD;
          -  Has a history of inflammatory bowel disease, a history of or ongoing pneumonitis or&#xD;
             interstitial lung disease, had major surgery ≤ 28 days prior to the first dose of&#xD;
             study drug and the surgical wound is not fully healed.&#xD;
&#xD;
          -  Participants with hypopharyngeal or laryngeal tumors will not be candidates for Arm 4&#xD;
             of the study (IT injection of ABBV-927).&#xD;
&#xD;
          -  Requires use of an immunosuppressive medication within 14 days prior to the first dose&#xD;
             of the study drug; exceptions are described in the protocol.&#xD;
&#xD;
          -  Has a confirmed positive test results for human immunodeficiency virus, or have active&#xD;
             hepatitis A, B or C.&#xD;
&#xD;
          -  Has a history of primary immunodeficiency, allogeneic bone marrow transplantation,&#xD;
             solid organ transplantation, or previous clinical diagnosis of tuberculosis.&#xD;
&#xD;
          -  Has a history of any other malignancy within the past 3 years except for successfully&#xD;
             treated non-melanoma skin cancer or localized carcinoma in situ that is considered&#xD;
             cured or adequately treated by the investigator.&#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>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital /ID# 207392</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan /ID# 210181</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center /ID# 208749</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Head and Neck Squamous Cell Carcinoma</keyword>
  <keyword>Cancer</keyword>
  <keyword>ABBV-927</keyword>
  <keyword>ABBV-368</keyword>
  <keyword>ABBV-181</keyword>
  <keyword>tumor resection</keyword>
  <keyword>immunotherapeutic drug</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_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/NCT03818542
org study id: M19-228
nct id: NCT03818542
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study
      drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced
      squamous cell carcinoma of the head and neck who are candidates for surgical resection.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Gene Expression
time frame: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)
description: The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.
measure: Maximum Serum Concentration (Cmax) of Study Drug
time frame: Up to approximately 120 days
description: Maximum Serum Concentration (Cmax) of study drug
measure: Time to Maximum Plasma Concentration (Tmax) of Study Drug
time frame: Up to approximately 120 days
description: Time to Maximum Plasma Concentration (Tmax) of study drug
measure: Area Under the Plasma Concentration-time Curve of Study Drug in Plasma
time frame: Up to approximately 120 days
description: Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma
arm group label: Arm 1: ABBV-181 IV
arm group type: Experimental
description: A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.
arm group label: Arm 2: ABBV-368 IV
arm group type: Experimental
description: A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.
arm group label: Arm 3: ABBV-927 IV
arm group type: Experimental
description: A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.
arm group label: Arm 4: ABBV-927 IT
arm group type: Experimental
description: A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.
intervention type: Drug
intervention name: ABBV-181
description: intravenous infusion
arm group label: Arm 1: ABBV-181 IV
intervention type: Drug
intervention name: ABBV-368
description: intravenous infusion
arm group label: Arm 2: ABBV-368 IV
intervention type: Drug
intervention name: ABBV-927
description: intravenous infusion
arm group label: Arm 3: ABBV-927 IV
intervention type: Drug
intervention name: ABBV-927
description: intratumoral injection
arm group label: Arm 4: ABBV-927 IT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
sharing ipd: No