<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/NCT03771859</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-8RX</org_study_id>
    <nct_id>NCT03771859</nct_id>
  </id_info>
  <brief_title>A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed</brief_title>
  <official_title>An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational study of melanoma participants who are eligible for and who have initiated&#xD;
      treatment with adjuvant nivolumab as part of routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and&#xD;
      retrospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2025</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>RFS (relapse free survival)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>DMFS (distant metastasis free survival)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS (overall survival)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of sociodemographic characteristics in participants initiating nivolumab</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics in participants initiating nivolumab</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of treatment patterns in participants initiating nivolumab</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)</measure>
    <time_frame>5 years</time_frame>
    <description>The EQ-5D is a standardized 3-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, where each dimension is rated by individuals as no problems, slight problems, moderate problems, severe problems, and extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>The EORTC-QLQ-C30 questionnaire is a 30-item instrument that comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires</measure>
    <time_frame>5 years</time_frame>
    <description>The FACT-M is a frequently used melanoma specific questionnaire which has been validated to assess HRQOL for patients with all stages of melanoma. Besides general questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being, it also contains specific questions related to melanoma, including a subscale on the melanoma surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AE's</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of SAE's</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Participants who initiate adjuvant treatment with nivolumab</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with melanoma with involvement of lymph nodes or metastatic disease who have&#xD;
        undergone complete resection, and who receive adjuvant nivolumab under real-world&#xD;
        conditions in Belgium or Luxembourg. Patients will be enrolled after complete surgical&#xD;
        resection and following a screen procedure (according to standard practice) that shows no&#xD;
        evidence of disease. Patients currently enrolled in an interventional clinical trial will&#xD;
        not be eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a primary diagnosis of melanoma with involvement of lymph nodes or&#xD;
             metastatic disease who have undergone complete resection and have no evidence of&#xD;
             disease.&#xD;
&#xD;
          -  Decision to treat with adjuvant nivolumab therapy has already been taken&#xD;
&#xD;
          -  At least 18 years of age at the time of treatment decision&#xD;
&#xD;
          -  Patients who provide written informed consent to participate in the study (for&#xD;
             retrospectively enrolled patients who are deceased at time of study start, a consent&#xD;
             waiver will be sought)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient with a diagnosis of persisting advanced melanoma prior to first&#xD;
             administration of nivolumab&#xD;
&#xD;
          -  Any patient currently enrolled in an interventional clinical trial for his/her&#xD;
             melanoma treatment (note: patients who have completed their participation in an&#xD;
             interventional trial or who are no longer receiving the study drug and are only&#xD;
             followed up for Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In&#xD;
             case of a blinded study, the treatment arm needs to be known).&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bouge</city>
        <zip>5004</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Brugge</city>
        <zip>B-8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Luxembourg</city>
        <zip>1210</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Luxembourg</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</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>


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/NCT03771859
org study id: CA209-8RX
nct id: NCT03771859
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
An observational study of melanoma participants who are eligible for and who have initiated
      treatment with adjuvant nivolumab as part of routine clinical practice.
Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and
      retrospectively.
observational model: Cohort
time perspective: Other
measure: RFS (relapse free survival)
time frame: 5 years
measure: DMFS (distant metastasis free survival)
time frame: 5 years
measure: OS (overall survival)
time frame: 5 years
measure: Distribution of sociodemographic characteristics in participants initiating nivolumab
time frame: 5 years
measure: Distribution of clinical characteristics in participants initiating nivolumab
time frame: 5 years
measure: Distribution of treatment patterns in participants initiating nivolumab
time frame: 5 years
measure: QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)
time frame: 5 years
description: The EQ-5D is a standardized 3-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, where each dimension is rated by individuals as no problems, slight problems, moderate problems, severe problems, and extreme problems.
measure: The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire
time frame: 5 years
description: The EORTC-QLQ-C30 questionnaire is a 30-item instrument that comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
measure: Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires
time frame: 5 years
description: The FACT-M is a frequently used melanoma specific questionnaire which has been validated to assess HRQOL for patients with all stages of melanoma. Besides general questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being, it also contains specific questions related to melanoma, including a subscale on the melanoma surgery
measure: Incidence of AE's
time frame: 5 years
measure: Incidence of SAE's
time frame: 5 years
arm group label: Participants who initiate adjuvant treatment with nivolumab
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Luxembourg
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Melanoma