<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/NCT03241745</url>
  </required_header>
  <id_info>
    <org_study_id>17-180</org_study_id>
    <nct_id>NCT03241745</nct_id>
  </id_info>
  <brief_title>A Study of Nivolumab in Selected Uterine Cancer Patients</brief_title>
  <official_title>Phase II Trial of Single-Agent Nivolumab in Patients With Microsatellite Unstable/Mismatch Repair Deficient/Hypermutated Uterine Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the safety of nivolumab and find out what affects, if&#xD;
      any, nivolumab has on people and their risk of gynecologic cancer. The investigators also&#xD;
      want to find out what effects, good or bad, nivolumab has on the patient and their cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</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>
    <intervention_model_description>This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase 2 study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival</measure>
    <time_frame>at 24 weeks</time_frame>
    <description>will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Uterine Cancer</condition>
  <condition>Endometrial Carcinoma</condition>
  <condition>Carcinosarcoma</condition>
  <condition>Leiomyosarcoma</condition>
  <condition>Undifferentiated Sarcoma</condition>
  <condition>High Grade Endometrial Stromal Sarcoma</condition>
  <condition>Clear Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab 480 mg IV once every 4 weeks</description>
    <arm_group_label>Nivolumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of metastatic or recurrent uterine cancer&#xD;
             (endometrial carcinoma, carcinosarcoma, clear cell carcinoma, leiomyosarcoma,&#xD;
             undifferentiated sarcoma, high grade endometrial stromal sarcoma) by Memorial Sloan&#xD;
             Kettering Cancer Center. Carcinosarcomas, endometrioid and clear cell carcinomas that&#xD;
             appears to have arisen in the ovary/fallopian tube or peritoneum are also eligible.&#xD;
             Recurrence should not be amenable to curative approaches such as surgical resection or&#xD;
             chemoradiotherapy.&#xD;
&#xD;
          -  Tumor is confirmed to be one of the following: 1. MSI-high, or 2. MMR-deficient, or 3.&#xD;
             Hypermutated defined as ≥20 somatic mutations in the tumor by MSK-IMPACT&#xD;
&#xD;
          -  One or more prior lines of cytotoxic treatment for advanced disease (prior hormonal&#xD;
             therapy is not considered to count as prior lines of therapy)&#xD;
&#xD;
          -  Measurable disease by RECIST 1.1 criteria&#xD;
&#xD;
          -  No known CNS metastases&#xD;
&#xD;
          -  ECOG Performance status 0-1&#xD;
&#xD;
          -  ECOG Performance status 0-1&#xD;
&#xD;
          -  WBC ≥ 2000/uL, ANC ≥ 1500/uL, PLT ≥ 100,000/uL, HGB ≥ 8 g/dL&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 40mL/min by Cockroft-Gault&#xD;
             formula&#xD;
&#xD;
          -  AST (SGOT) and ALT (SGPT) ≤ 3 x ULN&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 x ULN, except subjects with Gilbert's syndrome who can have&#xD;
             total bilirubin ≤ 3.0 mg/dL&#xD;
&#xD;
          -  Able to sign voluntary written informed consent&#xD;
&#xD;
          -  Female, 18 years of age or older&#xD;
&#xD;
          -  Available archival tumor tissue or patient is willing to undergo new biopsy&#xD;
&#xD;
          -  Premenopausal women of child bearing potential must have a normal urine or serum&#xD;
             beta-HCG prior to enrollment, and must agree to use effective contraception during&#xD;
             treatment with nivolumab and for at least 5 months following the last dose of&#xD;
             nivolumab.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease eligible for potentially curative treatment with standard chemotherapy,&#xD;
             surgical resection, or chemoradiotherapy.&#xD;
&#xD;
          -  Known or suspected autoimmune disease, except for subjects with vitiligo, diabetes&#xD;
             mellitus, resolved childhood asthma/atopy, residual hypothyroidism due to an&#xD;
             autoimmune immune condition only requiring thyroid hormone replacement, psoriasis not&#xD;
             requiring systemic treatment, or conditions not expected to recur in the absence of an&#xD;
             external trigger.&#xD;
&#xD;
          -  Serious uncontrolled medical disorder or active infection which would impair the&#xD;
             ability of the subject to receive protocol therapy or whose control would be&#xD;
             jeopardized by protocol therapy&#xD;
&#xD;
          -  History of bowel obstruction, refractory ascites, or bowel perforation due to advanced&#xD;
             disease within the past 3 months from start of study treatment.&#xD;
&#xD;
          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4&#xD;
             antibody or any other antibody or drug specifically targeting T cell co-stimulation or&#xD;
             immune checkpoint pathways&#xD;
&#xD;
          -  Patients who have a condition that requires systemic treatment with either&#xD;
             corticosteroids within 7 days of enrollment (systemic corticosteroid therapy is&#xD;
             defined as &gt;10 mg daily prednisone or its equivalent); or who require other&#xD;
             immunosuppressive medications within 14 days of study drug administration. Inhaled or&#xD;
             topical steroids and adrenal replacement doses &gt; 10 mg daily prednisone equivalents&#xD;
             are permitted in the absence of active autoimmune disease.&#xD;
&#xD;
          -  Prior history of malignancy or a concurrent malignancy, with the exception of&#xD;
             cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer,&#xD;
             or in situ carcinoma of the uterine cervix, prostate, or breast, unless a complete&#xD;
             remission was achieved at least 3 years prior to study entry and no additional therapy&#xD;
             is required or anticipated to be required during the study period&#xD;
&#xD;
          -  Breastfeeding women, pregnant women&#xD;
&#xD;
          -  Prisoners or subjects who are involuntarily incarcerated&#xD;
&#xD;
          -  Subjects who are compulsorily detained for treatment of either a psychiatric or&#xD;
             physical illness&#xD;
&#xD;
               -  Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C&#xD;
                  virus ribonucleic acid (HCV antibody) indicating acute or chronic infection (if&#xD;
                  patient has documented Hepatitis B and C from within 6 months of enrollment,&#xD;
                  these tests do not need to be repeated.)&#xD;
&#xD;
          -  Known history of testing positive for human immunodeficiency virus (HIV) or known&#xD;
             acquired immunodeficiency syndrome (AIDS)&#xD;
&#xD;
          -  Known allergy or Adverse Drug Reaction to nivolumab, or a history of allergy to study&#xD;
             drug components.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Friedman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nivolumab</keyword>
  <keyword>17-180</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Leiomyosarcoma</mesh_term>
    <mesh_term>Uterine Neoplasms</mesh_term>
    <mesh_term>Carcinosarcoma</mesh_term>
    <mesh_term>Adenomyoepithelioma</mesh_term>
    <mesh_term>Adenocarcinoma, Clear Cell</mesh_term>
    <mesh_term>Sarcoma, Endometrial Stromal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03241745
org study id: 17-180
nct id: NCT03241745
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to test the safety of nivolumab and find out what affects, if
      any, nivolumab has on people and their risk of gynecologic cancer. The investigators also
      want to find out what effects, good or bad, nivolumab has on the patient and their cancer.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase 2 study.
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival
time frame: at 24 weeks
description: will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
arm group label: Nivolumab
arm group type: Experimental
description: Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab 480 mg IV once every 4 weeks
arm group label: Nivolumab
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claire Friedman, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Sarcoma
mesh term: Endometrial Neoplasms
mesh term: Leiomyosarcoma
mesh term: Uterine Neoplasms
mesh term: Carcinosarcoma
mesh term: Adenomyoepithelioma
mesh term: Adenocarcinoma, Clear Cell
mesh term: Sarcoma, Endometrial Stromal
mesh term: Nivolumab
sharing ipd: Undecided