<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/NCT03798639</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-18231</org_study_id>
    <secondary_id>NCI-2018-03329</secondary_id>
    <nct_id>NCT03798639</nct_id>
  </id_info>
  <brief_title>Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer</brief_title>
  <official_title>Randomized, Multi-Institutional Pilot Study of Nivolumab and Radiation Therapy Versus Nivolumab and Ipilimumab as Adjuvant Therapy for Merkel Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claire Verschraegen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</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 phase I trial studies the side effects and how well nivolumab works when given together&#xD;
      with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel&#xD;
      cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may&#xD;
      help the body?s immune system attack the cancer, and may interfere with the ability of tumor&#xD;
      cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons,&#xD;
      protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with&#xD;
      radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the tolerability of two different experimental immunotherapy regimens in the&#xD;
      adjuvant setting in patients with Merkel cell carcinoma (MCC).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the safety and tolerability profile of each of the treatment using Common&#xD;
      Terminology Criteria for Adverse Events (CTCAE) version 5.0.&#xD;
&#xD;
      II. To assess the efficacy of each of the treatment arms according to recurrence-free&#xD;
      survival (RFS) at one and half years, defined as the time between the date of randomization&#xD;
      and the date of first progression (local, regional or distant metastasis) or death (whatever&#xD;
      the cause), whichever occurs first.&#xD;
&#xD;
      III. To assess the efficacy of each of the treatment arms according to overall survival (OS)&#xD;
      at three years, defined from the time of randomization and the date of death, compared to&#xD;
      historical registry control.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To explore potential biomarkers, next generation T cell receptor (TCR) sequencing will be&#xD;
      performed to identify and longitudinally track individual T cell clones thus granting a&#xD;
      comprehensive insight into immunological changes that occur within the tumor and peripheral&#xD;
      blood throughout the course of the disease.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes at week 0. Treatments&#xD;
      repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable&#xD;
      toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5&#xD;
      days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM B: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at&#xD;
      week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1&#xD;
      year in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for 2 years and&#xD;
      then every 6 months for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients completing 12 months of treatment</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be estimated along with the 95% confidence interval for each arm based on the binomial distribution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival (RFS) one and half years</measure>
    <time_frame>Time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), assessed up to one and half years.</time_frame>
    <description>Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and overall survival (OS), for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival at three years</measure>
    <time_frame>Time from randomization to the date of death, assessed up to 3 years</time_frame>
    <description>Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and OS, for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 3 years post treatment</time_frame>
    <description>Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Side effects will be summarized by each treatment group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>T cell analysis</measure>
    <time_frame>Baseline up to 3 years post treatment</time_frame>
    <description>TT cell analysis will be performed using peripheral blood at regular time points during the study period</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Merkel Cell Carcinoma</condition>
  <condition>Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm I (nivolumab, radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive nivolumab IV over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (nivolumab, ipilimumab)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm II (nivolumab, ipilimumab)</arm_group_label>
    <other_name>Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody</other_name>
    <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>Arm I (nivolumab, radiation therapy)</arm_group_label>
    <arm_group_label>Arm II (nivolumab, ipilimumab)</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>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Receive radiation therapy</description>
    <arm_group_label>Arm I (nivolumab, radiation therapy)</arm_group_label>
    <other_name>Cancer Radiotherapy</other_name>
    <other_name>Irradiate</other_name>
    <other_name>Irradiated</other_name>
    <other_name>irradiation</other_name>
    <other_name>Radiation</other_name>
    <other_name>Radiotherapeutics</other_name>
    <other_name>RADIOTHERAPY</other_name>
    <other_name>RT</other_name>
    <other_name>Therapy, Radiation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing and able to understand and give written informed consent and comply with&#xD;
             all study related procedures&#xD;
&#xD;
          -  All patients should undergo definitive surgical resection, including when possible&#xD;
             sentinel lymph node dissection&#xD;
&#xD;
          -  Patients must have recovered after any recent surgery and be ambulatory&#xD;
&#xD;
          -  Have node positive disease (stage pIIIA or pIIIB) +/- extracapsular extension&#xD;
&#xD;
          -  Have node negative disease and any of the following high risk features&#xD;
&#xD;
               -  Tumor size &gt;= 2 cm&#xD;
&#xD;
               -  Margins =&lt; 1-2 cm and re-resection is not possible&#xD;
&#xD;
               -  Evidence of perineural or lymphovascular invasion&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) patients with undetectable viral load and CD4+&#xD;
             T-cell counts &gt;= 350 cells/uL&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1,500/mcL (performed within 16 days of treatment&#xD;
             initiation)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL in the absence of transfusion support within 7 days of&#xD;
             determining eligibility (performed within 16 days of treatment initiation)&#xD;
&#xD;
          -  Hemoglobin &gt;= 8 g/dL (performed within 16 days of treatment initiation)&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x upper limit of normal (ULN) OR Measured or calculated&#xD;
             creatinine clearance &gt;= 40 mL/min creatinine clearance (performed within 16 days of&#xD;
             treatment initiation) (Glomerular filtration rate [GFR] can also be used in place of&#xD;
             creatinine or creatinine clearance [CrCl])&#xD;
&#xD;
               -  Creatinine clearance should be calculated per institutional standard&#xD;
&#xD;
          -  Serum total bilirubin =&lt; 1.5 x ULN OR Except subjects with Gilbert Syndrome, who can&#xD;
             have total bilirubin &lt; 3.0 x ULN (performed within 16 days of treatment initiation)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and&#xD;
             alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =&lt; 3.0 x&#xD;
             ULN (performed within 16 days of treatment initiation)&#xD;
&#xD;
          -  Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy at screening and within 24 hours prior to receiving the first dose of study&#xD;
             medication and then every 4 weeks while on treatment. If the urine test is positive or&#xD;
             cannot be confirmed as negative, a serum pregnancy test will be required&#xD;
&#xD;
          -  Female subjects of childbearing potential should be willing to use 2 methods of birth&#xD;
             control or be surgically sterile, or abstain from heterosexual activity for the course&#xD;
             of the study through 5 months after the last dose of study medication. Subjects should&#xD;
             agree to ongoing pregnancy testing during the course of the study and after the end of&#xD;
             study therapy. Female subjects of childbearing potential are those who have not been&#xD;
             surgically sterilized or have not been free from menses for &gt; 1 year&#xD;
&#xD;
          -  Male subjects should agree to use an adequate method of contraception starting with&#xD;
             the first dose of study therapy through 7 months after the last dose of study therapy.&#xD;
             Males must refrain from donating sperm during study participation and for 7 months&#xD;
             after the last dose of study medication. Female subject should agree to use an&#xD;
             adequate method of contraception starting with the first dose of study therapy through&#xD;
             5 months after the last dose of study therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has known distant metastatic MCC&#xD;
&#xD;
          -  Has a known history of active TB (Bacillus tuberculosis)&#xD;
&#xD;
          -  Hypersensitivity to any study agents&#xD;
&#xD;
          -  Have received prior immunotherapy with any PD-1/PDL-1 inhibitors or CTLA-4 antibodies&#xD;
             at any time in the past&#xD;
&#xD;
          -  Has had prior chemotherapy or radiation therapy for treatment of MCC&#xD;
&#xD;
          -  Has a clinically significant medical condition, which in the judgment of the attending&#xD;
             physician would contraindicate immunotherapy or radiotherapy, such as serious&#xD;
             autoimmune disease, hypersensitivity to investigational product or any component in&#xD;
             its formulations, per Food and Drug Administration (FDA) prescription notice&#xD;
&#xD;
          -  Subjects with prior history of non-Merkel cell carcinoma malignancies are excluded&#xD;
             except&#xD;
&#xD;
               -  Adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic&#xD;
                  leukemia (CLL) or other indolent malignancies not requiring therapy (ie. active&#xD;
                  surveillance)&#xD;
&#xD;
               -  Adequately treated malignancies and patient has been in complete remission for at&#xD;
                  least two years&#xD;
&#xD;
               -  Patients with history of breast cancer and no evidence of disease on hormonal&#xD;
                  therapy to prevent recurrence&#xD;
&#xD;
               -  Patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA&#xD;
                  are eligible&#xD;
&#xD;
          -  Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment&#xD;
&#xD;
          -  Subjects with a condition requiring systemic treatment with either corticosteroids (&gt;&#xD;
             10 mg daily prednisone equivalent) or other immunosuppressive medications within 14&#xD;
             days of randomization will be excluded. Inhaled or topical steroids are permitted in&#xD;
             the absence of active autoimmune disease&#xD;
&#xD;
          -  Has an active infection requiring intravenous systemic therapy&#xD;
&#xD;
          -  Solid organ transplant recipients and patients with concurrent hematological&#xD;
             malignancies including thymomas, leukemias (other than CLL) and lymphomas actively&#xD;
             undergoing treatment or completed &lt; 5 years prior&#xD;
&#xD;
          -  Clinically significant cardiovascular disease with uncontrolled arrhythmia, New York&#xD;
             Association class 3 or 4 congestive heart failure, history of myocardial infarction&#xD;
             within 6 months, or prolonged corrected QT (QTc) &gt; 500 msec&#xD;
&#xD;
          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment&#xD;
&#xD;
          -  Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg]&#xD;
             reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA]&#xD;
             [qualitative] is detected)&#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>Claire Verschraegen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Claire Verschraegen</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>Carcinoma, Merkel Cell</mesh_term>
    <mesh_term>Carcinoma</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03798639
org study id: OSU-18231
secondary id: NCI-2018-03329
nct id: NCT03798639
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the side effects and how well nivolumab works when given together
      with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel
      cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may
      help the body?s immune system attack the cancer, and may interfere with the ability of tumor
      cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons,
      protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with
      radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.
PRIMARY OBJECTIVES:

      I. To assess the tolerability of two different experimental immunotherapy regimens in the
      adjuvant setting in patients with Merkel cell carcinoma (MCC).

      SECONDARY OBJECTIVES:

      I. To assess the safety and tolerability profile of each of the treatment using Common
      Terminology Criteria for Adverse Events (CTCAE) version 5.0.

      II. To assess the efficacy of each of the treatment arms according to recurrence-free
      survival (RFS) at one and half years, defined as the time between the date of randomization
      and the date of first progression (local, regional or distant metastasis) or death (whatever
      the cause), whichever occurs first.

      III. To assess the efficacy of each of the treatment arms according to overall survival (OS)
      at three years, defined from the time of randomization and the date of death, compared to
      historical registry control.

      EXPLORATORY OBJECTIVES:

      I. To explore potential biomarkers, next generation T cell receptor (TCR) sequencing will be
      performed to identify and longitudinally track individual T cell clones thus granting a
      comprehensive insight into immunological changes that occur within the tumor and peripheral
      blood throughout the course of the disease.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes at week 0. Treatments
      repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable
      toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5
      days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.

      ARM B: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at
      week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1
      year in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then every 6 months for 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients completing 12 months of treatment
time frame: Up to 12 months
description: Will be estimated along with the 95% confidence interval for each arm based on the binomial distribution.
measure: Recurrence-free survival (RFS) one and half years
time frame: Time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), assessed up to one and half years.
description: Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and overall survival (OS), for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated.
measure: Overall survival at three years
time frame: Time from randomization to the date of death, assessed up to 3 years
description: Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and OS, for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated.
measure: Incidence of adverse events (AEs)
time frame: Up to 3 years post treatment
description: Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Side effects will be summarized by each treatment group.
measure: T cell analysis
time frame: Baseline up to 3 years post treatment
description: TT cell analysis will be performed using peripheral blood at regular time points during the study period
arm group label: Arm I (nivolumab, radiation therapy)
arm group type: Experimental
description: Patients receive nivolumab IV over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
arm group label: Arm II (nivolumab, ipilimumab)
arm group type: Active Comparator
description: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Ipilimumab
description: Given IV
arm group label: Arm II (nivolumab, ipilimumab)
other name: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
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: Arm I (nivolumab, radiation therapy)
arm group label: Arm II (nivolumab, ipilimumab)
other name: BMS-936558
other name: MDX-1106
other name: NIVO
other name: ONO-4538
other name: Opdivo
intervention type: Radiation
intervention name: Radiation Therapy
description: Receive radiation therapy
arm group label: Arm I (nivolumab, radiation therapy)
other name: Cancer Radiotherapy
other name: Irradiate
other name: Irradiated
other name: irradiation
other name: Radiation
other name: Radiotherapeutics
other name: RADIOTHERAPY
other name: RT
other name: Therapy, Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claire Verschraegen, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Claire Verschraegen
investigator title: Principal Investigator
mesh term: Carcinoma, Merkel Cell
mesh term: Carcinoma
mesh term: Nivolumab
mesh term: Ipilimumab
sharing ipd: No