<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/NCT01693783</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2012-02877</org_study_id>
    <secondary_id>NCI-2012-02877</secondary_id>
    <secondary_id>PHL-085</secondary_id>
    <secondary_id>PHL-085</secondary_id>
    <secondary_id>9209</secondary_id>
    <secondary_id>N01CM00032</secondary_id>
    <secondary_id>N01CM00038</secondary_id>
    <secondary_id>N01CM00071</secondary_id>
    <secondary_id>U10CA180821</secondary_id>
    <secondary_id>UM1CA186705</secondary_id>
    <nct_id>NCT01693783</nct_id>
  </id_info>
  <brief_title>Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer</brief_title>
  <official_title>A Phase 2 Study of Ipilimumab in Women With Metastatic or Recurrent HPV-Related Cervical Carcinoma of Either Squamous Cell or Adenocarcinoma Histologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well ipilimumab works in treating patients with human&#xD;
      papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other&#xD;
      areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help&#xD;
      kill them or carry tumor-killing substances to them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the safety of ipilimumab in eligible patients with recurrent or metastatic&#xD;
      cervical cancer.&#xD;
&#xD;
      II. To assess the antitumor activity of ipilimumab in eligible patients with recurrent or&#xD;
      metastatic cervical cancer via assessment of objective response rates (ORR).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the antitumor activity of ipilimumab through secondary endpoints including of&#xD;
      disease stabilization and progression free survival (PFS).&#xD;
&#xD;
      II. Assessment of antitumor activity of ipilimumab using immune-related response criteria&#xD;
      (irRC) III. Assessment of the predictive value of baseline C-reactive protein. IV. Assess the&#xD;
      biologic responses of exposure to ipilimumab via correlative studies involving analysis of&#xD;
      lymphocyte subsets and assessment of cervical cancer-antigen specific T cells anti-tumor&#xD;
      response.&#xD;
&#xD;
      V. Evaluation of archival tissue with regard to markers of immune population in correlation&#xD;
      with clinical stage and response to treatment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive ipilimumab intravenously (IV) over 90 minutes. Treatment repeats every 21&#xD;
      days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients&#xD;
      achieving objective response or stable disease continue to receive maintenance therapy&#xD;
      comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of&#xD;
      disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2012</start_date>
  <completion_date type="Actual">November 24, 2021</completion_date>
  <primary_completion_date type="Actual">March 18, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Cumulative count of adverse events meeting the criteria of: frequently occurring, serious and severe events of interest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Response Rate Using Response Evaluation Criteria in Solid Tumors</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antitumor Activity (Partial Response, Complete Response, and Stable Disease) Using Immune-related Response Criteria (irRC)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Immune-Related Complete Response (irCR): complete disappearance of all lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). irStable Disease (irSD): does not meet criteria for irCR or irPR, in the absence of progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biologic Responses of Exposure to Ipilimumab by Analysis of Lymphocyte Subsets and Assessment of Cervical Cancer-antigen Specific T Cells Anti-tumor Response</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of Participants with Cervical Cancer-antigen Specific T Cells Anti-tumor Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Stabilization</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>As per RECIST v1.1, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of Immune Population, Evaluated in Archival Tissue</measure>
    <time_frame>Baseline to 1 year after treatment</time_frame>
    <description>Evaluation of archival tissue with regard to markers of immune population in correlation with clinical stage and response to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive Value of Baseline C-reactive Protein</measure>
    <time_frame>Up to week 3 of course 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year</time_frame>
    <description>Progressive disease (PD), as per RECIST v1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions and an absolute increase of at least 5mm, or the appearance of one or more new lesions. Computed using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cervical Adenocarcinoma</condition>
  <condition>Cervical Squamous Cell Carcinoma</condition>
  <condition>Human Papillomavirus Infection</condition>
  <condition>Recurrent Cervical Carcinoma</condition>
  <condition>Stage IVA Cervical Cancer AJCC v6 and v7</condition>
  <condition>Stage IVB Cervical Cancer AJCC v6 and v7</condition>
  <arm_group>
    <arm_group_label>Treatment (ipilimumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses 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>Treatment (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>Ipilimumab Biosimilar CS1002</other_name>
    <other_name>MDX-010</other_name>
    <other_name>MDX-CTLA4</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (ipilimumab)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically or cytologically confirmed metastatic or recurrent&#xD;
             cervical cancer of squamous, adenocarcinoma or mixed histology type not suited to&#xD;
             definitive localized therapy; HPV status will be confirmed for all patients following&#xD;
             enrollment&#xD;
&#xD;
          -  Patients must have measurable disease, defined as at least one lesion that can be&#xD;
             accurately measured in at least one dimension (longest diameter to be recorded for&#xD;
             non-nodal lesions and short axis for nodal lesions) as &gt; 10 mm with computed&#xD;
             tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam&#xD;
&#xD;
          -  Previous therapy:&#xD;
&#xD;
               -  Patients may have undergone surgery and/or received definitive radiation or&#xD;
                  chemo-radiation for localized disease in the past&#xD;
&#xD;
               -  Radiation treatment with curative intent (radical chemoradiotherapy or adjuvant&#xD;
                  chemoradiotherapy) must have been completed &gt;= 3 months prior to enrollment&#xD;
&#xD;
                    -  Note: patients who completed palliative radiation therapy 2 weeks before&#xD;
                       start of ipilimumab are allowed as long as this does not affect measurable&#xD;
                       disease&#xD;
&#xD;
               -  Patients must have been exposed to platinum chemotherapy either as part of&#xD;
                  definitive chemo-radiation OR as first line systemic treatment for metastatic&#xD;
                  disease&#xD;
&#xD;
               -  Patients MAY have received up to two prior lines of systemic chemotherapy for&#xD;
                  metastatic or recurrent disease; patients with metastatic disease at first&#xD;
                  presentation MUST have received one platinum based line of chemotherapy&#xD;
&#xD;
               -  All chemotherapy must have been completed &gt;= 4 weeks prior to enrollment with&#xD;
                  radiologic evidence of radiological disease progression&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Life expectancy of greater than 3 months&#xD;
&#xD;
          -  Leukocytes &gt;= 3.0 x 10^9/L&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1.5 x 10^9/L&#xD;
&#xD;
          -  Platelets &gt;= 100 x 10^9/L&#xD;
&#xD;
          -  Total bilirubin within normal institutional limits (except in Gilbert's syndrome)&#xD;
&#xD;
          -  Thyroid stimulating hormone (TSH) =&lt; upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 x institutional upper limit of normal&#xD;
&#xD;
          -  Creatinine &lt; 1.25 ULN OR creatinine clearance &gt;= 50 mL/min/1.73 m^2 as calculated by&#xD;
             the Cockcroft and Gault formula&#xD;
&#xD;
          -  All radiology studies must be performed =&lt; 3 weeks prior to the start of therapy&#xD;
&#xD;
          -  Subjects with treated and asymptomatic brain metastases are eligible; patients that&#xD;
             received palliative radiation (for brain metastases) are eligible if they have been&#xD;
             asymptomatic for at least 2 weeks with use of maintenance steroid therapy, and last&#xD;
             received radiation at least 4 weeks prior to start of therapy&#xD;
&#xD;
          -  Ability to understand and willing to sign a written informed consent document&#xD;
&#xD;
          -  Ongoing prior toxicities related to previous treatments must be recovered to =&lt; grade&#xD;
             1 at the time of registration (with the exception of alopecia or skin depigmentation)&#xD;
&#xD;
          -  Patients are willing to undergo tumor biopsy pre-treatment (within 14 days prior to&#xD;
             registration) and post-treatment (within the first week of cycle 2 onset); patients&#xD;
             who consent but have tumor that is not amenable to safe biopsy will be allowed to&#xD;
             enter the trial/continue therapy as per protocol if this has been addressed and&#xD;
             permission is granted from the lead consortium principal investigator (PI) prior to&#xD;
             registration continuation of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy &lt; 4 weeks prior to enrollment (&lt; 6 weeks for&#xD;
             nitrosoureas or mitomycin C) or who had radiation therapy with curative intent &lt; 3&#xD;
             months prior to enrollment (&lt; 2 weeks for palliative radiation therapy) or those who&#xD;
             have not recovered (=&lt; grade 1) from adverse events related to previous treatments are&#xD;
             excluded&#xD;
&#xD;
          -  Patients with a history of prior treatment with ipilimumab or other cytotoxic&#xD;
             T-lymphocyte antigen 4 (CTLA4) agonists or antagonists, anti-programmed death 1 (PD 1)&#xD;
             antibody, cluster of differentiation (CD)137 agonist or other immune activating&#xD;
             therapy such as anti-CD 40 antibody are excluded&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents&#xD;
&#xD;
          -  Autoimmune disease: patients with a history of inflammatory bowel disease, including&#xD;
             ulcerative colitis and Crohn's disease, are excluded from this study, as are patients&#xD;
             with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic&#xD;
             progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune&#xD;
             vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor&#xD;
             neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and&#xD;
             Myasthenia Gravis, multiple sclerosis)&#xD;
&#xD;
          -  Patients requiring immunosuppressive agents, unless required for treating potential&#xD;
             immune related adverse effects; steroids at their lowest effective dose in patients&#xD;
             with radiated brain metastases is permitted&#xD;
&#xD;
          -  Patients with known immune impairment who may be unable to respond to anti-CTLA 4&#xD;
             antibody&#xD;
&#xD;
          -  Any other prior malignancy from which the patient has been disease free for less than&#xD;
             3 years, with the exception of adequately treated and cured basal or squamous cell&#xD;
             skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other&#xD;
             cancer&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to ipilimumab&#xD;
&#xD;
          -  Patients requiring systemic steroids are excluded; narcotics should be used with&#xD;
             caution&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements; patients with chronic hepatitis B or hepatitis C infections should&#xD;
             be excluded&#xD;
&#xD;
          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if&#xD;
             the mother is treated with ipilimumab&#xD;
&#xD;
          -  Patients with active or chronic infection with human immunodeficiency virus (HIV) who&#xD;
             have raised viral loads or uncontrolled disease are ineligible; those patients however&#xD;
             who exhibit minimal viral loads with good control whilst on stable anti-viral regimen&#xD;
             may be considered if they meet all other eligibility criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit M Oza</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network Princess Margaret Cancer Center P2C</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope South Pasadena</name>
      <address>
        <city>South Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Research Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA-Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Program</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital and Cancer Center-General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network-Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>June 28, 2022</results_first_submitted>
  <results_first_submitted_qc>October 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2022</results_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 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>Papillomavirus Infections</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT01693783/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Ipilimumab)</title>
          <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Ipilimumab)</title>
          <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" lower_limit="23" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0</title>
        <description>Cumulative count of adverse events meeting the criteria of: frequently occurring, serious and severe events of interest.</description>
        <time_frame>Up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0</title>
          <description>Cumulative count of adverse events meeting the criteria of: frequently occurring, serious and severe events of interest.</description>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate Using Response Evaluation Criteria in Solid Tumors</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.</description>
        <time_frame>Up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate Using Response Evaluation Criteria in Solid Tumors</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antitumor Activity (Partial Response, Complete Response, and Stable Disease) Using Immune-related Response Criteria (irRC)</title>
        <description>Immune-Related Complete Response (irCR): complete disappearance of all lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). irStable Disease (irSD): does not meet criteria for irCR or irPR, in the absence of progressive disease.</description>
        <time_frame>Up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Antitumor Activity (Partial Response, Complete Response, and Stable Disease) Using Immune-related Response Criteria (irRC)</title>
          <description>Immune-Related Complete Response (irCR): complete disappearance of all lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). irStable Disease (irSD): does not meet criteria for irCR or irPR, in the absence of progressive disease.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biologic Responses of Exposure to Ipilimumab by Analysis of Lymphocyte Subsets and Assessment of Cervical Cancer-antigen Specific T Cells Anti-tumor Response</title>
        <description>Number of Participants with Cervical Cancer-antigen Specific T Cells Anti-tumor Response</description>
        <time_frame>Up to 1 year</time_frame>
        <population>Not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Biologic Responses of Exposure to Ipilimumab by Analysis of Lymphocyte Subsets and Assessment of Cervical Cancer-antigen Specific T Cells Anti-tumor Response</title>
          <description>Number of Participants with Cervical Cancer-antigen Specific T Cells Anti-tumor Response</description>
          <population>Not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Stabilization</title>
        <description>As per RECIST v1.1, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.</description>
        <time_frame>Up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Stabilization</title>
          <description>As per RECIST v1.1, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Markers of Immune Population, Evaluated in Archival Tissue</title>
        <description>Evaluation of archival tissue with regard to markers of immune population in correlation with clinical stage and response to treatment</description>
        <time_frame>Baseline to 1 year after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Markers of Immune Population, Evaluated in Archival Tissue</title>
          <description>Evaluation of archival tissue with regard to markers of immune population in correlation with clinical stage and response to treatment</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PD-L1 expression negative at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 expression is 1% to 10% at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 expression is more than 10% at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 expression not available at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 expression from negative at baseline to positive after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDO expression negatve at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDO expression positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDO expression missing at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Predictive Value of Baseline C-reactive Protein</title>
        <time_frame>Up to week 3 of course 4</time_frame>
        <population>Not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Predictive Value of Baseline C-reactive Protein</title>
          <population>Not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival</title>
        <description>Progressive disease (PD), as per RECIST v1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions and an absolute increase of at least 5mm, or the appearance of one or more new lesions. Computed using the Kaplan-Meier method.</description>
        <time_frame>Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ipilimumab)</title>
            <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Progressive disease (PD), as per RECIST v1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions and an absolute increase of at least 5mm, or the appearance of one or more new lesions. Computed using the Kaplan-Meier method.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).</time_frame>
      <desc>Adverse events collected as per protocol using CTCAE version 4.0</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Ipilimumab)</title>
          <description>Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.&#xD;
Ipilimumab: Given IV&#xD;
Laboratory Biomarker Analysis: Correlative studies</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Colonic fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Colonic obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Retroperitoneal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bladder Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pelvic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Acute Kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hemorrhoid</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rectal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Edema Limbs</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Localized Edema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINEMIA</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>White Blood Cell Decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESEMIA</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Peripheral Motor Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary Frequency</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary Tract Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic Pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vaginal Discharge</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vaginal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Allergic Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Thromboembolic Event</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hot Flashes</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The primary limitation of the trial was the single-arm design. This was a phase 1/2 trial assessing ipilimumab monotherapy with no control arm.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Amit Oza</name_or_title>
      <organization>University Health Network - Princess Margaret Cancer Centre</organization>
      <phone>416-946-4501 ext 3911</phone>
      <email>Amit.Oza@uhn.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01693783
org study id: NCI-2012-02877
secondary id: NCI-2012-02877
secondary id: PHL-085
secondary id: PHL-085
secondary id: 9209
secondary id: N01CM00032
secondary id: N01CM00038
secondary id: N01CM00071
secondary id: U10CA180821
secondary id: UM1CA186705
nct id: NCT01693783
lead sponsor: 
has dmc: Yes
This phase II trial studies how well ipilimumab works in treating patients with human
      papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other
      areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help
      kill them or carry tumor-killing substances to them.
PRIMARY OBJECTIVES:

      I. To assess the safety of ipilimumab in eligible patients with recurrent or metastatic
      cervical cancer.

      II. To assess the antitumor activity of ipilimumab in eligible patients with recurrent or
      metastatic cervical cancer via assessment of objective response rates (ORR).

      SECONDARY OBJECTIVES:

      I. To assess the antitumor activity of ipilimumab through secondary endpoints including of
      disease stabilization and progression free survival (PFS).

      II. Assessment of antitumor activity of ipilimumab using immune-related response criteria
      (irRC) III. Assessment of the predictive value of baseline C-reactive protein. IV. Assess the
      biologic responses of exposure to ipilimumab via correlative studies involving analysis of
      lymphocyte subsets and assessment of cervical cancer-antigen specific T cells anti-tumor
      response.

      V. Evaluation of archival tissue with regard to markers of immune population in correlation
      with clinical stage and response to treatment.

      OUTLINE:

      Patients receive ipilimumab intravenously (IV) over 90 minutes. Treatment repeats every 21
      days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients
      achieving objective response or stable disease continue to receive maintenance therapy
      comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 1 year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
time frame: Up to 1 year
description: Cumulative count of adverse events meeting the criteria of: frequently occurring, serious and severe events of interest.
measure: Objective Response Rate Using Response Evaluation Criteria in Solid Tumors
time frame: Up to 1 year
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
measure: Antitumor Activity (Partial Response, Complete Response, and Stable Disease) Using Immune-related Response Criteria (irRC)
time frame: Up to 1 year
description: Immune-Related Complete Response (irCR): complete disappearance of all lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). irStable Disease (irSD): does not meet criteria for irCR or irPR, in the absence of progressive disease.
measure: Biologic Responses of Exposure to Ipilimumab by Analysis of Lymphocyte Subsets and Assessment of Cervical Cancer-antigen Specific T Cells Anti-tumor Response
time frame: Up to 1 year
description: Number of Participants with Cervical Cancer-antigen Specific T Cells Anti-tumor Response
measure: Disease Stabilization
time frame: Up to 1 year
description: As per RECIST v1.1, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
measure: Markers of Immune Population, Evaluated in Archival Tissue
time frame: Baseline to 1 year after treatment
description: Evaluation of archival tissue with regard to markers of immune population in correlation with clinical stage and response to treatment
measure: Predictive Value of Baseline C-reactive Protein
time frame: Up to week 3 of course 4
measure: Progression Free Survival
time frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year
description: Progressive disease (PD), as per RECIST v1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions and an absolute increase of at least 5mm, or the appearance of one or more new lesions. Computed using the Kaplan-Meier method.
arm group label: Treatment (ipilimumab)
arm group type: Experimental
description: Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Ipilimumab
description: Given IV
arm group label: Treatment (ipilimumab)
other name: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
other name: BMS-734016
other name: Ipilimumab Biosimilar CS1002
other name: MDX-010
other name: MDX-CTLA4
other name: Yervoy
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (ipilimumab)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amit M Oza
role: Principal Investigator
affiliation: University Health Network Princess Margaret Cancer Center P2C
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Papillomavirus Infections
mesh term: Carcinoma
mesh term: Adenocarcinoma
mesh term: Uterine Cervical Neoplasms
mesh term: Recurrence
mesh term: Ipilimumab
provided document: 
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reported events: 
certain agreements: 
limitations and caveats: The primary limitation of the trial was the single-arm design. This was a phase 1/2 trial assessing ipilimumab monotherapy with no control arm.
point of contact: 