<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/NCT03769155</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00104273</org_study_id>
    <secondary_id>NCI-2018-01229</secondary_id>
    <secondary_id>Winship4400-18</secondary_id>
    <secondary_id>P30CA138292</secondary_id>
    <nct_id>NCT03769155</nct_id>
  </id_info>
  <brief_title>VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma</brief_title>
  <official_title>Pilot Integrated Biomarker Study of VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Resectable Metastatic Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vaccinex Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab&#xD;
      and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed&#xD;
      by surgery. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab may interfere&#xD;
      with the ability of tumor cells to grow and spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Evaluate the effect of VX15/2503 (pepinemab) in combination with immune checkpoint&#xD;
      inhibitors on T cell infiltrate into the tumor microenvironment in involved and uninvolved&#xD;
      lymph nodes and peripheral blood.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate the effect of VX15/2503 in combination with immune checkpoint inhibitors on the&#xD;
      immune profile of involved and uninvolved lymph nodes and peripheral blood.&#xD;
&#xD;
      II. Assess safety and tolerability of profile and tolerability of single agent VX15/2503 to&#xD;
      the combination of VX15/2503 and immune checkpoint inhibitors in patients with resectable&#xD;
      metastatic melanoma.&#xD;
&#xD;
      III. Document pathologic response rates of single agent VX15/2503 and combination VX15/2503&#xD;
      and immune checkpoint inhibitors in patients with resectable melanoma.&#xD;
&#xD;
      IV. Compare pathologic response to radiographic response using Response Evaluation Criteria&#xD;
      in Solid Tumors (RECIST) criteria in patients receiving single agent VX15/2503 and&#xD;
      combination VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.&#xD;
&#xD;
      OUTLINE: Participants are assigned to 1 of 5 arms.&#xD;
&#xD;
      ARM I: Participants receive VX15/2503 intravenously (IV) over 60 minutes and nivolumab IV&#xD;
      over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.&#xD;
&#xD;
      ARM II: Participants receive VX15/2503 IV over 60 minutes and ipilimumab IV over 30 minutes&#xD;
      on days 1 and 21 and undergo surgery between days 35-49.&#xD;
&#xD;
      ARM III: Participants receive VX15/2503 IV over 60 minutes, nivolumab IV over 30 minutes, and&#xD;
      ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.&#xD;
&#xD;
      ARM IV: Participants nivolumab IV over 30 minutes on days 1 and 21 and undergo between days&#xD;
      35-49.&#xD;
&#xD;
      ARM V: Participants undergo surgery.&#xD;
&#xD;
      After completion of study treatment, participants are followed up at 90 days, every 12 weeks&#xD;
      for 2 years, every 6 months for 3 years, then annually up to 10 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2031</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment</measure>
    <time_frame>Up to 10 years after study start</time_frame>
    <description>The two-sample t-test will be used to compare the change in CD8+ T cell infiltration after treatment between each experimental group (Cohort A, B, C, and D) and the control group (cohort E), respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</measure>
    <time_frame>Up to 8 weeks after surgery</time_frame>
    <description>Descriptive statistics for worst grade of each laboratory parameter by the NCI CTCAE scale version 4.0 at baseline and follow-up will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>Up to 10 years after study start</time_frame>
    <description>For participants to be considered evaluable for efficacy, they must have completed the treatment and have a baseline tumor assessment. Response rate will be calculated as proportion (responders/total participants).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Assessed up to 10 years after study start</time_frame>
    <description>For overall survival, death from any cause will be defined as the event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Assessed up to 10 years after study start</time_frame>
    <description>Progression or death from any cause will be defined as the event.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Pathologic Stage IIIB Cutaneous Melanoma AJCC v8</condition>
  <condition>Pathologic Stage IIIC Cutaneous Melanoma AJCC v8</condition>
  <condition>Pathologic Stage IIID Cutaneous Melanoma AJCC v8</condition>
  <arm_group>
    <arm_group_label>A (VX15/2503, nivolumab, surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive VX15/2503 (pepinemab) IV over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B (VX15/2503, ipilimumab, surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive VX15/2503 (pepinemab) IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C (VX15/2503, nivolumab, ipilimumab, surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive VX15/2503 (pepinemab) IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D (nivolumab, surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive nivolumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E (surgery)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants undergo surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>B (VX15/2503, ipilimumab, surgery)</arm_group_label>
    <arm_group_label>C (VX15/2503, nivolumab, ipilimumab, surgery)</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>MDX-010</other_name>
    <other_name>MDX-CTLA4</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>A (VX15/2503, nivolumab, surgery)</arm_group_label>
    <arm_group_label>C (VX15/2503, nivolumab, ipilimumab, surgery)</arm_group_label>
    <arm_group_label>D (nivolumab, surgery)</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>MDX-1106</other_name>
    <other_name>NIVO</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VX15/2503</intervention_name>
    <description>Given IV</description>
    <arm_group_label>A (VX15/2503, nivolumab, surgery)</arm_group_label>
    <arm_group_label>B (VX15/2503, ipilimumab, surgery)</arm_group_label>
    <arm_group_label>C (VX15/2503, nivolumab, ipilimumab, surgery)</arm_group_label>
    <other_name>moAb VX15/2503</other_name>
    <other_name>Pepinemab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Undergo therapeutic conventional surgery</description>
    <arm_group_label>A (VX15/2503, nivolumab, surgery)</arm_group_label>
    <arm_group_label>B (VX15/2503, ipilimumab, surgery)</arm_group_label>
    <arm_group_label>C (VX15/2503, nivolumab, ipilimumab, surgery)</arm_group_label>
    <arm_group_label>D (nivolumab, surgery)</arm_group_label>
    <arm_group_label>E (surgery)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage IIIB, IIIC, IIID histologically-proven melanoma.&#xD;
&#xD;
               -  Cancer confirmed to be surgically resectable, with surgery evaluation with&#xD;
                  planned prior to resection.&#xD;
&#xD;
               -  No prior immunotherapy with cytotoxic T-lymphocyte associated protein-4 (CTLA-4),&#xD;
                  anti programmed cell death-1 (PD-1) or VX15/2503. Prior interferon (at least 1&#xD;
                  year prior to consent) will be allowed.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 1,500 cells/µL.&#xD;
&#xD;
          -  Platelets ≥ 100,000/µL.&#xD;
&#xD;
          -  Hemoglobin ≥ 9.0g/dL (may receive packed red blood cells [PRBC] transfusion).&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 x the upper limit of normal (ULN).&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.&#xD;
&#xD;
          -  Albumin ≥ 3.0 g/dL.&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance of ≥ 50 mL/min using&#xD;
             Cockcroft-Gault formula.&#xD;
&#xD;
          -  International normalized ration (INR) ≤ 1.5. Anticoagulation is allowed only with low&#xD;
             molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic&#xD;
             dose for more than 2 weeks or with factor Xa level &lt; 1.1 U/mL are allowed on the&#xD;
             trial.&#xD;
&#xD;
          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory&#xD;
             tests, and other study procedures.&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Female subjects of childbearing potential must agree to use adequate contraception (at&#xD;
             least one highly effective method and one additional method of birth control at the&#xD;
             same time or complete abstinence) prior to study entry, for the duration of study&#xD;
             treatment and 5 months after last dose of study treatment.&#xD;
&#xD;
          -  Male subjects must agree to use adequate contraception (at least one highly effective&#xD;
             method and one additional method of birth control at the same time or complete&#xD;
             abstinence) prior to study entry, for the duration of study treatment and 7 months&#xD;
             after last dose of study treatment.&#xD;
&#xD;
          -  Female subjects of childbearing age must have a negative serum pregnancy test at study&#xD;
             entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Determined not to be a surgical candidate due to medical co-morbidities.&#xD;
&#xD;
          -  Treatment with chronic immunosuppressants (e.g., cyclosporine following&#xD;
             transplantation).&#xD;
&#xD;
          -  Prior organ allograft or allogeneic bone marrow transplantation.&#xD;
&#xD;
          -  Subjects with active or history of immune mediated pneumonitis, colitis, hepatitis,&#xD;
             endocrinopathy, nephritis, or skin reactions as these patients may be at increased&#xD;
             risk for developing immune therapy-induced exacerbation or recurrence of their immune&#xD;
             mediated disease, potentially delaying surgery.&#xD;
&#xD;
          -  Subjects with a condition requiring systemic treatment with either corticosteroids (&gt;&#xD;
             10 mg daily prednisone equivalents) or other immunosuppressive medications within 14&#xD;
             days of study drug administration. Inhaled or topical steroids and adrenal replacement&#xD;
             doses &gt; 10 mg daily prednisone equivalents are permitted in the absence of active&#xD;
             autoimmune disease.&#xD;
&#xD;
          -  Women who are pregnant or lactating.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, human&#xD;
             immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral&#xD;
             therapy, ongoing or active infection, symptomatic congestive heart failure (NYHA class&#xD;
             III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements.&#xD;
&#xD;
          -  Other medications, or severe acute/chronic medical or psychiatric condition, or&#xD;
             laboratory abnormality that may increase the risk associated with study participation&#xD;
             or study drug administration, or may interfere with the interpretation of study&#xD;
             results, and in the judgment of the investigator would make the subject inappropriate&#xD;
             for entry into this study.&#xD;
&#xD;
          -  Clinical evidence of bleeding diathesis or coagulopathy.&#xD;
&#xD;
          -  Patients with prior malignancies, including pelvic cancer, are eligible if they have&#xD;
             been disease free for &gt; 5 years. Patients with prior non-melanoma skin cancers and in&#xD;
             situ carcinomas are eligible provided there was complete removal.&#xD;
&#xD;
          -  Active bacterial or fungal infections requiring systemic treatment within 7 days of&#xD;
             treatment.&#xD;
&#xD;
          -  Use of other investigational drugs (drugs not marked for any indication) within 28&#xD;
             days or at least 5 half-lives (whichever is longer) before study drug administration.&#xD;
&#xD;
          -  History of severe hypersensitivity reactions to other monoclonal antibodies.&#xD;
&#xD;
          -  Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab.&#xD;
&#xD;
          -  Prisoners and subjects who are compulsory detained.&#xD;
&#xD;
          -  Patients with rapidly progressive disease.&#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>Michael Lowe, MD, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Michael Lowe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Skin Neoplasms</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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03769155/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03769155
org study id: IRB00104273
secondary id: NCI-2018-01229
secondary id: Winship4400-18
secondary id: P30CA138292
nct id: NCT03769155
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab
      and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed
      by surgery. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab may interfere
      with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVE:

      I. Evaluate the effect of VX15/2503 (pepinemab) in combination with immune checkpoint
      inhibitors on T cell infiltrate into the tumor microenvironment in involved and uninvolved
      lymph nodes and peripheral blood.

      SECONDARY OBJECTIVES:

      I. Evaluate the effect of VX15/2503 in combination with immune checkpoint inhibitors on the
      immune profile of involved and uninvolved lymph nodes and peripheral blood.

      II. Assess safety and tolerability of profile and tolerability of single agent VX15/2503 to
      the combination of VX15/2503 and immune checkpoint inhibitors in patients with resectable
      metastatic melanoma.

      III. Document pathologic response rates of single agent VX15/2503 and combination VX15/2503
      and immune checkpoint inhibitors in patients with resectable melanoma.

      IV. Compare pathologic response to radiographic response using Response Evaluation Criteria
      in Solid Tumors (RECIST) criteria in patients receiving single agent VX15/2503 and
      combination VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.

      OUTLINE: Participants are assigned to 1 of 5 arms.

      ARM I: Participants receive VX15/2503 intravenously (IV) over 60 minutes and nivolumab IV
      over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

      ARM II: Participants receive VX15/2503 IV over 60 minutes and ipilimumab IV over 30 minutes
      on days 1 and 21 and undergo surgery between days 35-49.

      ARM III: Participants receive VX15/2503 IV over 60 minutes, nivolumab IV over 30 minutes, and
      ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.

      ARM IV: Participants nivolumab IV over 30 minutes on days 1 and 21 and undergo between days
      35-49.

      ARM V: Participants undergo surgery.

      After completion of study treatment, participants are followed up at 90 days, every 12 weeks
      for 2 years, every 6 months for 3 years, then annually up to 10 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment
time frame: Up to 10 years after study start
description: The two-sample t-test will be used to compare the change in CD8+ T cell infiltration after treatment between each experimental group (Cohort A, B, C, and D) and the control group (cohort E), respectively.
measure: Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: Up to 8 weeks after surgery
description: Descriptive statistics for worst grade of each laboratory parameter by the NCI CTCAE scale version 4.0 at baseline and follow-up will be presented.
measure: Response rate
time frame: Up to 10 years after study start
description: For participants to be considered evaluable for efficacy, they must have completed the treatment and have a baseline tumor assessment. Response rate will be calculated as proportion (responders/total participants).
measure: Overall survival (OS)
time frame: Assessed up to 10 years after study start
description: For overall survival, death from any cause will be defined as the event.
measure: Progression-free survival (PFS)
time frame: Assessed up to 10 years after study start
description: Progression or death from any cause will be defined as the event.
arm group label: A (VX15/2503, nivolumab, surgery)
arm group type: Experimental
description: Participants receive VX15/2503 (pepinemab) IV over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.
arm group label: B (VX15/2503, ipilimumab, surgery)
arm group type: Experimental
description: Participants receive VX15/2503 (pepinemab) IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.
arm group label: C (VX15/2503, nivolumab, ipilimumab, surgery)
arm group type: Experimental
description: Participants receive VX15/2503 (pepinemab) IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.
arm group label: D (nivolumab, surgery)
arm group type: Experimental
description: Participants receive nivolumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.
arm group label: E (surgery)
arm group type: Active Comparator
description: Participants undergo surgery.
intervention type: Biological
intervention name: Ipilimumab
description: Given IV
arm group label: B (VX15/2503, ipilimumab, surgery)
arm group label: C (VX15/2503, nivolumab, ipilimumab, surgery)
other name: BMS-734016
other name: MDX-010
other name: MDX-CTLA4
other name: Yervoy
intervention type: Biological
intervention name: Nivolumab
description: Given IV
arm group label: A (VX15/2503, nivolumab, surgery)
arm group label: C (VX15/2503, nivolumab, ipilimumab, surgery)
arm group label: D (nivolumab, surgery)
other name: BMS-936558
other name: MDX-1106
other name: NIVO
other name: ONO-4538
other name: Opdivo
intervention type: Biological
intervention name: VX15/2503
description: Given IV
arm group label: A (VX15/2503, nivolumab, surgery)
arm group label: B (VX15/2503, ipilimumab, surgery)
arm group label: C (VX15/2503, nivolumab, ipilimumab, surgery)
other name: moAb VX15/2503
other name: Pepinemab
intervention type: Procedure
intervention name: Surgery
description: Undergo therapeutic conventional surgery
arm group label: A (VX15/2503, nivolumab, surgery)
arm group label: B (VX15/2503, ipilimumab, surgery)
arm group label: C (VX15/2503, nivolumab, ipilimumab, surgery)
arm group label: D (nivolumab, surgery)
arm group label: E (surgery)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Lowe, MD, MA
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Michael Lowe
investigator title: Principal Investigator
mesh term: Melanoma
mesh term: Skin Neoplasms
mesh term: Nivolumab
mesh term: Ipilimumab
provided document: 