<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/NCT02990611</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-654</org_study_id>
    <nct_id>NCT02990611</nct_id>
  </id_info>
  <brief_title>Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy</brief_title>
  <acronym>NICO</acronym>
  <official_title>A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe the safety and effectiveness of nivolumab treatment,&#xD;
      either in monotherapy or in combination with ipilimumab, overall and according to various&#xD;
      subgroups of interest, in participants with advanced melanoma and in participants with&#xD;
      adjuvant nivolumab therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS) of nivolumab/ipilimumab combination therapy</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relapse free survival (RFS) of adjuvant nivolumab therapy</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) of nivolumab monotherapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response of monotherapy and combination therapy</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of sociodemographic characteristics: Age</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of sociodemographic characteristics: Gender</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of sociodemographic characteristics: BMI</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Initial diagnosis of melanoma</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Diagnosis of advanced melanoma</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Clinical code and staging melanoma subtypes</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Comorbidities</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Diagnostic procedures</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Mutation status</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Medical history</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Concomitant medication</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: History of cancer</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of treatment patterns: Type of treatment previously received</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of treatment patterns: Stage of melanoma</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of treatment patterns: Current treatment details</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of adverse events (AEs)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of management of adverse events (AEs)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) of adjuvant therapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1087</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Nivolumab/Ipilimumab combination therapy</arm_group_label>
    <description>Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Nivolumab monotherapy</arm_group_label>
    <description>Participants who start a new systemic therapy with nivolumab monotherapy for the first time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: Nivolumab adjuvant therapy</arm_group_label>
    <description>Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants who are at least 18 years of age of the time of treatment decision with&#xD;
        a primary diagnosis of advanced melanoma (histologically confirmed Stage III [unresectable]&#xD;
        or Stage IV skin, ocular, or mucosal melanoma) and whose physician has already decided to&#xD;
        initiate a treatment with nivolumab or nivolumab/ipilimumab for the first time for the&#xD;
        treatment of melanoma, according to the label approved in Germany. Participants with a&#xD;
        current primary diagnosis of a cancer other than advanced melanoma, participants currently&#xD;
        included in an interventional clinical trial, or participants who have already received&#xD;
        nivolumab in a prior line of therapy (for monotherapy arm) will all be excluded from this&#xD;
        study. Adult participants in the adjuvant nivolumab treatment cohort will be enrolled after&#xD;
        complete surgical resection and no evidence of disease after the treating physician has&#xD;
        decided to initiate an adjuvant therapy with nivolumab according to the label approved in&#xD;
        Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Cohort 1 and 2: (Recruitment ended by 02/20/2020)&#xD;
&#xD;
          -  Advanced melanoma (Stage III/Stage IV)&#xD;
&#xD;
          -  Histologically confirmed diagnosis&#xD;
&#xD;
          -  Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination&#xD;
             therapy has already been taken&#xD;
&#xD;
        For Cohort 3: (Recruitment ended by 08/31/2020)&#xD;
&#xD;
          -  Primary diagnosis of advanced melanoma after complete surgical tumor resection and no&#xD;
             evidence of disease&#xD;
&#xD;
          -  Treatment decision for adjuvant nivolumab therapy has already been taken&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For Cohort 1 and 2: (Recruitment ended by 02/20/2020)&#xD;
&#xD;
          -  Current primary diagnosis of a cancer other than advanced melanoma, that requires&#xD;
             systemic or other treatment or has not been treated curatively (as per discretion of&#xD;
             the investigator)&#xD;
&#xD;
          -  Previous treatment with nivolumab, for nivolumab monotherapy cohort only&#xD;
&#xD;
          -  Current active participation in an interventional clinical trial&#xD;
&#xD;
        For Cohort 3: (Recruitment ended by 08/31/2020)&#xD;
&#xD;
          -  Current diagnosis of persisting advanced melanoma or a cancer other than advanced&#xD;
             melanoma that requires systemic or other treatment or has not been treated curatively&#xD;
             (as per discretion of the investigator)&#xD;
&#xD;
          -  Current active participation in an interventional clinical trial&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria 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>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</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>April 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</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/NCT02990611
org study id: CA209-654
nct id: NCT02990611
lead sponsor: 
has dmc: No
The purpose of this study is to describe the safety and effectiveness of nivolumab treatment,
      either in monotherapy or in combination with ipilimumab, overall and according to various
      subgroups of interest, in participants with advanced melanoma and in participants with
      adjuvant nivolumab therapy.
observational model: Cohort
time perspective: Prospective
measure: Overall survival (OS) of nivolumab/ipilimumab combination therapy
time frame: 5 years
measure: Relapse free survival (RFS) of adjuvant nivolumab therapy
time frame: 5 years
measure: Overall survival (OS) of nivolumab monotherapy
time frame: 5 years
measure: Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest
time frame: 5 years
measure: Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
time frame: 5 years
measure: Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
time frame: 5 years
measure: Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy
time frame: 5 years
measure: Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
time frame: 5 years
measure: Duration of response of monotherapy and combination therapy
time frame: Up to 5 years
measure: Distribution of sociodemographic characteristics: Age
time frame: 5 years
measure: Distribution of sociodemographic characteristics: Gender
time frame: 5 years
measure: Distribution of sociodemographic characteristics: BMI
time frame: 5 years
measure: Distribution of clinical characteristics: Initial diagnosis of melanoma
time frame: 5 years
measure: Distribution of clinical characteristics: Diagnosis of advanced melanoma
time frame: 5 years
measure: Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)
time frame: 5 years
measure: Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease
time frame: 5 years
measure: Distribution of clinical characteristics: Clinical code and staging melanoma subtypes
time frame: 5 years
measure: Distribution of clinical characteristics: Comorbidities
time frame: 5 years
measure: Distribution of clinical characteristics: Diagnostic procedures
time frame: 5 years
measure: Distribution of clinical characteristics: Mutation status
time frame: 5 years
measure: Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale
time frame: 5 years
measure: Distribution of clinical characteristics: Medical history
time frame: 5 years
measure: Distribution of clinical characteristics: Concomitant medication
time frame: 5 years
measure: Distribution of clinical characteristics: History of cancer
time frame: 5 years
measure: Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)
time frame: 5 years
measure: Distribution of treatment patterns: Type of treatment previously received
time frame: 5 years
measure: Distribution of treatment patterns: Stage of melanoma
time frame: 5 years
measure: Distribution of treatment patterns: Current treatment details
time frame: 5 years
measure: European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)
time frame: 5 years
measure: Incidence of adverse events (AEs)
time frame: 5 years
measure: Severity of adverse events (AEs)
time frame: 5 years
measure: Distribution of management of adverse events (AEs)
time frame: 5 years
measure: Overall survival (OS) of adjuvant therapy
time frame: 5 years
arm group label: Cohort 1: Nivolumab/Ipilimumab combination therapy
description: Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time
arm group label: Cohort 2: Nivolumab monotherapy
description: Participants who start a new systemic therapy with nivolumab monotherapy for the first time
arm group label: Cohort 3: Nivolumab adjuvant therapy
description: Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease
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: 
country: Germany
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