xml: <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/NCT05984615</url>
    </required_header>
    <id_info>
      <org_study_id>CTMT212AUS63</org_study_id>
      <nct_id>NCT05984615</nct_id>
    </id_info>
    <brief_title>Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients</brief_title>
    <official_title>Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This was a retrospective real-world evidence cohort study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 8, 2022</start_date>
    <completion_date type="Actual">August 24, 2022</completion_date>
    <primary_completion_date type="Actual">August 24, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mean age</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of male patients</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Race</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean Charlson comorbidity index (CCI) score</measure>
      <time_frame>Baseline</time_frame>
      <description>Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Eastern Cooperative Oncology Group performance status (ECOG PS)</measure>
      <time_frame>Baseline</time_frame>
      <description>The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with study-related biomarkers</measure>
      <time_frame>Baseline</time_frame>
      <description>Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of metastatic sites</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>6 months and 1, 1.5, and 2 years</time_frame>
      <description>PFS was defined as the time from the initiation of a line of therapy until the date of progression or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>6 months and 1, 1.5, and 2 years</time_frame>
      <description>OS was defined as the time from the initiation of a line of therapy until death from any cause.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">1961</enrollment>
    <condition>BRAF Positive Metastatic Melanoma</condition>
    <arm_group>
      <arm_group_label>Immunotherapy (IO) Cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Targeted Therapy (TT) Cohort</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Diagnosis of melanoma (The International Classification of Diseases, 9th Revision&#xD;
               [ICD-9] 172.x &amp; 10th revision [ICD-10] C43 or D03x).&#xD;
  &#xD;
            -  Pathologic stage IV at initial diagnosis on or after 01 January 2011.&#xD;
  &#xD;
            -  First-line treatment with IO monotherapy or combination therapy (nivolumab,&#xD;
               pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib +&#xD;
               trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January&#xD;
               2014.&#xD;
  &#xD;
            -  Evidence of a BRAF test.&#xD;
  &#xD;
            -  Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L)&#xD;
               therapy initiation.&#xD;
  &#xD;
            -  At least 18 years of age at the time of initiation of 1L treatment.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Documented receipt of a clinical trial treatment for cancer at any time on or after 01&#xD;
               January 2014.&#xD;
  &#xD;
            -  Diagnosis of a second primary cancer or secondary cancer following initiation of 1L&#xD;
               metastatic melanoma (MM) treatment.&#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>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Novartis</name>
        <address>
          <city>East Hanover</city>
          <state>New Jersey</state>
          <zip>07936</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melanoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984615
  org study id: CTMT212AUS63
  nct id: NCT05984615
  lead sponsor: 
  This was a retrospective real-world evidence cohort study.
  observational model: Cohort
  time perspective: Retrospective
  measure: Mean age
  time frame: Baseline
  measure: Number of male patients
  time frame: Baseline
  measure: Race
  time frame: Baseline
  measure: Mean Charlson comorbidity index (CCI) score
  time frame: Baseline
  description: Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.
  measure: Eastern Cooperative Oncology Group performance status (ECOG PS)
  time frame: Baseline
  description: The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.
  measure: Number of patients with study-related biomarkers
  time frame: Baseline
  description: Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.
  measure: Number of metastatic sites
  time frame: Baseline
  measure: Progression-free survival (PFS)
  time frame: 6 months and 1, 1.5, and 2 years
  description: PFS was defined as the time from the initiation of a line of therapy until the date of progression or death.
  measure: Overall survival (OS)
  time frame: 6 months and 1, 1.5, and 2 years
  description: OS was defined as the time from the initiation of a line of therapy until death from any cause.
  arm group label: Immunotherapy (IO) Cohort
  arm group label: Targeted Therapy (TT) Cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Melanoma