<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/NCT04495010</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-7UA</org_study_id>
    <secondary_id>2020-000070-16</secondary_id>
    <nct_id>NCT04495010</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants</brief_title>
  <acronym>CheckMate 7UA</acronym>
  <official_title>A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III 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>
    <has_dmc>No</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 purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to&#xD;
      demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma&#xD;
      participants with clinically detectable nodal disease and a high risk of recurrence.&#xD;
      Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens&#xD;
      while detectable tumor is still present, inducing a stronger and broader tumor-specific&#xD;
      immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant&#xD;
      combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may&#xD;
      translate to prolonged clinical benefit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business objectives have changed&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 31, 2021</start_date>
  <completion_date type="Anticipated">October 23, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>Event-free survival (EFS)</measure>
    <time_frame>Up to 4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival (RFS) Time from Surgery</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RFS Time from Adjuvant Therapy</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathologic response rate (pRR) by immune-related pathologic response (irPR)</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance major pathologic response (MPR) by local and central pathology Review</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RFS by MPR</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of deaths</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Hematology tests</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant treatment + Adjuvant treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Neo treat with patho response-driven Adju treat or observation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Adjuvant treatment</arm_group_label>
    <arm_group_label>Neo treat with patho response-driven Adju treat or observation</arm_group_label>
    <arm_group_label>Neoadjuvant treatment + Adjuvant treatment</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Neo treat with patho response-driven Adju treat or observation</arm_group_label>
    <arm_group_label>Neoadjuvant treatment + Adjuvant treatment</arm_group_label>
    <other_name>Yervoy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, ≥ 12 years of age [Except: where local regulations and/or&#xD;
             institutional policies do not allow for participants &lt; 18 years of age (adolescent&#xD;
             population) to participate. For those sites, the eligible participant population is 18&#xD;
             years of age or local age of majority, inclusive]&#xD;
&#xD;
          -  Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID&#xD;
             cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system,&#xD;
             with ≥ 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are&#xD;
             measurable according to Response Evaluation Criteria In Solid Tumors version 1.1&#xD;
             (RECIST 1.1)&#xD;
&#xD;
          -  Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative&#xD;
             Oncology Group (ECOG) scale performance status of 0 or 1. Adolescents &lt; 16 years old&#xD;
             must have Lanksky Play-Performance Status scale performance of ≥ 60&#xD;
&#xD;
          -  Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy&#xD;
             for melanoma or unresectable/metastatic melanoma)&#xD;
&#xD;
          -  Women and men must agree to follow specific methods of contraception, if applicable,&#xD;
             while participating in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are breastfeeding&#xD;
&#xD;
          -  Patients with serious or uncontrolled medical disorders&#xD;
&#xD;
          -  Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed&#xD;
             death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic&#xD;
             T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically&#xD;
             targeting T-cell co-stimulation or checkpoint pathways&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 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>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
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        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
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        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
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      <name>Local Institution</name>
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        <country>United States</country>
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        <state>Minnesota</state>
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        <country>United States</country>
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        <zip>39401</zip>
        <country>United States</country>
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      <name>Local Institution</name>
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        <country>United States</country>
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        <country>Australia</country>
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        <country>Austria</country>
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      <name>Local Institution</name>
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        <country>Brazil</country>
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        <country>Brazil</country>
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        <country>Brazil</country>
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    <facility>
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      <address>
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        <country>Brazil</country>
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        <country>Brazil</country>
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  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
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    <country>Poland</country>
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    <country>Spain</country>
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  <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.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_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/NCT04495010
org study id: CA209-7UA
secondary id: 2020-000070-16
nct id: NCT04495010
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to
      demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma
      participants with clinically detectable nodal disease and a high risk of recurrence.
      Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens
      while detectable tumor is still present, inducing a stronger and broader tumor-specific
      immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant
      combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may
      translate to prolonged clinical benefit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Event-free survival (EFS)
time frame: Up to 4 years
measure: Recurrence-free survival (RFS) Time from Surgery
time frame: Up to 5 years
measure: RFS Time from Adjuvant Therapy
time frame: Up to 5 years
measure: Pathologic response rate (pRR) by immune-related pathologic response (irPR)
time frame: Up to 5 years
measure: Concordance major pathologic response (MPR) by local and central pathology Review
time frame: Up to 5 years
description: MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
measure: RFS by MPR
time frame: Up to 5 years
measure: Incidence of Adverse Events (AEs)
time frame: Up to 5 years
measure: Incidence of Serious Adverse Events (SAEs)
time frame: Up to 5 years
measure: Incidence of deaths
time frame: Up to 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
time frame: Up to 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
time frame: Up to 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
time frame: Up to 5 years
measure: Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
time frame: Up to 5 years
arm group label: Neoadjuvant treatment + Adjuvant treatment
arm group type: Experimental
arm group label: Adjuvant treatment
arm group type: Experimental
arm group label: Neo treat with patho response-driven Adju treat or observation
arm group type: Experimental
description: Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
intervention type: Biological
intervention name: Nivolumab
description: Specified dose on specified days
arm group label: Adjuvant treatment
arm group label: Neo treat with patho response-driven Adju treat or observation
arm group label: Neoadjuvant treatment + Adjuvant treatment
other name: Opdivo
intervention type: Biological
intervention name: Ipilimumab
description: Specified dose on specified days
arm group label: Neo treat with patho response-driven Adju treat or observation
arm group label: Neoadjuvant treatment + Adjuvant treatment
other name: Yervoy
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Australia
country: Austria
country: Belgium
country: Brazil
country: Denmark
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Russian Federation
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Nivolumab
mesh term: Ipilimumab