<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/NCT02971761</url>
  </required_header>
  <id_info>
    <org_study_id>16131</org_study_id>
    <secondary_id>NCI-2016-01759</secondary_id>
    <secondary_id>16131</secondary_id>
    <nct_id>NCT02971761</nct_id>
  </id_info>
  <brief_title>Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer</brief_title>
  <official_title>A Phase 2 Clinical Trial of the Combination of Pembrolizumab and Selective Androgen Receptor Modulator (SARM) GTX-024 in Patients With Metastatic Androgen Receptor (AR) Positive Triple Negative Breast Cancer (TNBC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in&#xD;
      treating patients with androgen receptor positive triple negative breast cancer that has&#xD;
      spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies,&#xD;
      such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere&#xD;
      with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast&#xD;
      cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of&#xD;
      androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than&#xD;
      pembrolizumab alone in treating patients with androgen receptor positive triple negative&#xD;
      breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the safety/tolerability of the combination regimen. II. To determine the&#xD;
      response rate (complete response [CR] or partial response [PR] via Response Evaluation&#xD;
      Criteria in Solid Tumors [RECIST] 1.1) of the combination of pembrolizumab with enobosarm&#xD;
      (GTx-024) in patients with advanced androgen receptor (AR) positive (+) triple negative&#xD;
      breast cancer (TNBC).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate clinical outcomes by RECIST 1.1 including clinical benefit rate (CBR) at 24&#xD;
      weeks, progression free-survival (PFS), duration of response (DOR), event free survival&#xD;
      (EFS), time-to-treatment failure (TTF); and overall survival (OS).&#xD;
&#xD;
      II. To evaluate the role of immune-related response criteria (irRECIST). III. To evaluate the&#xD;
      association of AR by immunohistochemistry (IHC) and clinical response.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the association of an AR gene expression signature and clinical response.&#xD;
&#xD;
      II. To evaluate genomic and phenotypic status of breast tumor. III. To evaluate the effect of&#xD;
      the combination therapy on peripheral blood circulating tumor cells (CTCs) and circulating&#xD;
      tumor deoxyribonucleic acid (DNA) (ctDNA).&#xD;
&#xD;
      IV. To evaluate the effect of combination therapy on tumor-derived exosomes (TEX) and TEX&#xD;
      associated immune biomarkers.&#xD;
&#xD;
      V. Immune correlatives:&#xD;
&#xD;
      Va. To evaluate pre-treatment programmed death ligand 1 (PD-L1) and tumor infiltrating&#xD;
      lymphocytes (TILs) as a predictor of response to combination therapy.&#xD;
&#xD;
      Vb. To evaluate specific TIL subsets (e.g. CD4, CD8, regulatory T cell [Treg] distribution)&#xD;
      and other immunological correlatives (e.g. T cell receptor [TCR] repertoire analysis) as&#xD;
      possible predictors of response.&#xD;
&#xD;
      Vc. To evaluate change in TILs as a result of the combination therapy. Vd. To evaluate&#xD;
      peripheral blood, immune biomarkers.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and enobosarm&#xD;
      orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 35 cycles&#xD;
      in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 and 90 days, every 3&#xD;
      months, and bi-annually.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">December 28, 2023</completion_date>
  <primary_completion_date type="Actual">October 28, 2020</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>Response Rate (Complete Response or Partial Response)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>Time to disease progression/relapse or death as a result of any cause, assessed up to 36 months</time_frame>
    <description>Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate</measure>
    <time_frame>At 16 weeks</time_frame>
    <description>Clinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Time to death as a result of any cause, assessed up to 36 months</time_frame>
    <description>Overall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Androgen Receptor Positive</condition>
  <condition>Estrogen Receptor Negative</condition>
  <condition>HER2/Neu Negative</condition>
  <condition>Metastatic Triple-Negative Breast Carcinoma</condition>
  <condition>Progesterone Receptor Negative</condition>
  <condition>Stage IV Breast Cancer AJCC v6 and v7</condition>
  <arm_group>
    <arm_group_label>Treatment (pembrolizumab, enobosarm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enobosarm</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (pembrolizumab, enobosarm)</arm_group_label>
    <other_name>Gtx-024</other_name>
    <other_name>Ostarine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (pembrolizumab, enobosarm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (pembrolizumab, enobosarm)</arm_group_label>
    <other_name>Keytruda</other_name>
    <other_name>Lambrolizumab</other_name>
    <other_name>MK-3475</other_name>
    <other_name>SCH 900475</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented informed consent&#xD;
&#xD;
          -  Willing to provide a sample from a recently obtained (within 42 days prior to&#xD;
             initiation of day 1) biopsy of a tumor lesion&#xD;
&#xD;
               -  If recently-obtained samples are unavailable an archived metastatic specimen not&#xD;
                  previously irradiated may be submitted upon agreement from the study principal&#xD;
                  investigator (PI)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 1&#xD;
&#xD;
          -  Life expectancy of &gt; 3 months&#xD;
&#xD;
          -  Metastatic triple negative breast cancer (TNBC)&#xD;
&#xD;
          -  Measurable disease per RECIST version (v)1.1 criteria: at least 1 lesion of &gt; 10 mm in&#xD;
             long axis diameter for non-lymph nodes or &gt; 15 mm in short axis diameter for lymph&#xD;
             nodes that is serially measurable according to RECIST 1.1 using computerized&#xD;
             tomography, magnetic resonance imaging, or panoramic and close-up color photography&#xD;
&#xD;
          -  Histologically proven diagnosis of TNBC per current American Society of Clinical&#xD;
             Oncology (ASCO)/College of American Pathologists (CAP) guideline&#xD;
&#xD;
               -  Estrogen receptor (ER) negative (ER expression =&lt; 10% positive tumor nuclei),&#xD;
                  progesterone receptor (PR) negative (PR expression =&lt; 10% positive tumor nuclei)&#xD;
                  and HER2 negative breast cancer by IHC and /or fluorescence in situ hybridization&#xD;
                  (FISH)&#xD;
&#xD;
          -  Androgen receptor positive (AR+)&#xD;
&#xD;
               -  Defined as &gt;= 50% nuclear AR staining by immunohistochemistry (IHC) in either the&#xD;
                  primary or metastatic lesion&#xD;
&#xD;
               -  NOTE: research testing of AR status is available at City of Hope (COH) Pathology&#xD;
&#xD;
          -  Resolution of grade 2 and above toxicities of most recent therapy except for stable&#xD;
             sensory neuropathy (=&lt; grade 2) and alopecia&#xD;
&#xD;
          -  Female (childbearing potential): use an adequate method of birth control (except&#xD;
             hormonal contraception) or be surgically sterile, or abstain from heterosexual&#xD;
             activity for the course of the study through 120 days after the last dose of study&#xD;
             medication&#xD;
&#xD;
               -  Childbearing potential defined as not being surgically sterilized or have not&#xD;
                  been free from menses for &gt; 1 year&#xD;
&#xD;
          -  Male: use and adequate method of contraception with the first dose of study therapy&#xD;
             through 120 days after the last dose of study therapy&#xD;
&#xD;
               -  Note: abstinence is acceptable if this is the usual lifestyle and preferred&#xD;
                  contraception for the subject&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1500/mm^3 (within 14 days prior to day 1 of&#xD;
             protocol therapy)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mm^3 (within 14 days prior to day 1 of protocol therapy)&#xD;
&#xD;
          -  Hemoglobin &gt;= 9 g/dL or &gt;= 5.6 mmol/L without transfusion or erythropoietin (EPO)&#xD;
             dependency (within 7 days of assessment) (within 14 days prior to day 1 of protocol&#xD;
             therapy)&#xD;
&#xD;
          -  Serum total bilirubin =&lt; 1.5 x upper limit of normal (ULN) OR direct bilirubin =&lt; ULN&#xD;
             if total bilirubin levels &gt; 1.5 x ULN (within 14 days prior to day 1 of protocol&#xD;
             therapy)&#xD;
&#xD;
          -  Albumin &gt;= 2.5 mg/dL (within 14 days prior to day 1 of protocol therapy)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 2.5 x ULN OR =&lt;&#xD;
             5.0 x ULN if liver metastases present (within 14 days prior to day 1 of protocol&#xD;
             therapy)&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x ULN OR creatinine clearance (if measured or calculated per&#xD;
             institutional standard; glomerular filtration rate [GFR] can also be used in place of&#xD;
             creatinine or creatinine clearance [CrCl]) &gt;= 60 mL/min if creatinine levels &gt; 1.5 x&#xD;
             ULN (within 14 days prior to day 1 of protocol therapy)&#xD;
&#xD;
          -  Female of childbearing potential only: negative urine or serum pregnancy test; if the&#xD;
             urine test is positive or cannot be confirmed as negative, a serum pregnancy test will&#xD;
             be required (within 14 days prior to day 1 of protocol therapy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anti-programmed cell death protein-1 (anti-PD-1), PD ligand-1 (PD-L1), PD ligand-2&#xD;
             (PD-L2) agent, an antibody targeting other immuno-regulatory receptors or mechanisms&#xD;
&#xD;
          -  Radiotherapy within 14 days prior to day 1 of protocol therapy&#xD;
&#xD;
          -  AR targeted agents (including GTx-024, enzalutamide or other AR targeted therapies)&#xD;
&#xD;
          -  Investigational agent within 21 days prior to day 1 of protocol therapy&#xD;
&#xD;
          -  Hormone replacement therapies (estrogens, megestrol acetate) within 14 days prior to&#xD;
             day 1 of protocol therapy&#xD;
&#xD;
          -  Live-virus vaccination within 30 days prior to day 1 of protocol therapy&#xD;
&#xD;
          -  Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery&#xD;
             within 21 days of the first dose of trial medication&#xD;
&#xD;
          -  Testosterone or testosterone-like agents (methyltestosterone, oxandrolone,&#xD;
             oxymetholone, danazol, fluoxymesterone, dehydroepiandrosterone, androstenedione) other&#xD;
             androgenic compounds or anti-androgens within 30 days prior to day 1 of protocol&#xD;
             therapy&#xD;
&#xD;
          -  Chronic systemic steroid therapy or on any other form of immunosuppressive medication&#xD;
&#xD;
          -  Unstable or untreated brain/leptomeningeal metastasis&#xD;
&#xD;
          -  Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI)&#xD;
             obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)&#xD;
&#xD;
          -  Active central nervous system metastases and/or carcinomatous meningitis&#xD;
&#xD;
          -  Severe hypersensitivity reaction to treatment with another monoclonal antibody&#xD;
&#xD;
          -  Active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (replacement therapies for hormone deficiencies are allowed)&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C&#xD;
&#xD;
          -  History of pneumonitis (non-infectious) that required steroids or current pneumonitis&#xD;
&#xD;
          -  Diagnosed with or treated for cancer within the previous two years, other than breast&#xD;
             cancer or non-melanoma carcinoma of the skin&#xD;
&#xD;
          -  Unable to swallow capsules&#xD;
&#xD;
          -  Currently on bisphosphonate or denosumab with elevated serum calcium levels corrected&#xD;
             for albumin/ionized calcium levels outside of institutional normal limits&#xD;
&#xD;
          -  Female: pregnant or lactating&#xD;
&#xD;
          -  Concomitant medical condition that precludes adequate study treatment compliance or&#xD;
             assessment, or increases subject risk, in the opinion of the investigator, such as but&#xD;
             not limited to:&#xD;
&#xD;
               -  Myocardial infarction or arterial thromboembolic events within 6 months prior to&#xD;
                  baseline or severe or unstable angina, New York Heart Association (NYHA) class&#xD;
                  III or IV disease, or a QTCB (corrected according to Bazett's formula) interval &gt;&#xD;
                  470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to&#xD;
                  NYHA; uncontrolled hypertension (systolic &gt; 150 and/or diastolic &gt; 100 mm Hg)&#xD;
&#xD;
               -  Acute and chronic active infectious disorders and non-malignant medical illnesses&#xD;
                  that are uncontrolled or whose control may be jeopardized by the complications of&#xD;
                  this study therapy&#xD;
&#xD;
               -  Impairment of gastrointestinal function or gastrointestinal disease that may&#xD;
                  significantly alter the absorption of study drugs (e.g., ulcerative disease,&#xD;
                  uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)&#xD;
&#xD;
          -  Prospective participants who, in the opinion of the investigator, may not be able to&#xD;
             comply with all study procedures (including compliance issues related to&#xD;
             feasibility/logistics)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuan Yuan</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Corona</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92879</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Antelope Valley</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Mission Hills</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Rancho Cucamonga</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</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>City of Hope West Covina</name>
      <address>
        <city>West Covina</city>
        <state>California</state>
        <zip>91790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>October 7, 2021</results_first_submitted>
  <results_first_submitted_qc>June 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 10, 2022</results_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</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>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</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>July 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02971761/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients seen at the City of Hope main campus and its surrounding affiliated community clinics.</recruitment_details>
      <pre_assignment_details>Study was conducted from June 1, 2017 to October 28, 2019.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Pembrolizumab, Enobosarm)</title>
          <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>GTx-024 drug supply was withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Pembrolizumab, Enobosarm)</title>
          <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" lower_limit="36" upper_limit="81"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </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/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>non-Hispanic White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of previous lines of therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Received 0-1 previous lines of therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received &gt;=2 previous lines of therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Performance Status (ECOG)</title>
          <description>Stage 0 Fully active, able to carry on all pre-disease performance without restriction&#xD;
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work&#xD;
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours&#xD;
Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours&#xD;
Completely disabled; cannot carry on any selfcare; totally confined to bed or chair&#xD;
Dead</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ECOG stage 0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG stage 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nottingham Histological grade</title>
          <description>Nottingham Histologic Grade (Elston-Ellis modification of Scharff-Bloom-Richardson grading system). Higher grades have tissue histologies that are more involved with cancer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial tumor stage</title>
          <description>Stages are per American Joint Committee on Cancer (AJCC) staging version 7.0. Stage III is a more advanced diagnosis than Stage II, which is in turn more advanced than Stage I.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Stage I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stage II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stage III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Lumpectomy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mastectomy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior radiation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes, received prior radiation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Response Rate (Complete Response or Partial Response)</title>
        <description>Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.</description>
        <time_frame>Up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Pembrolizumab, Enobosarm)</title>
            <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate (Complete Response or Partial Response)</title>
          <description>Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Progressive disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
        <time_frame>Time to disease progression/relapse or death as a result of any cause, assessed up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Pembrolizumab, Enobosarm)</title>
            <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</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="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.9" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Benefit Rate</title>
        <description>Clinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1.</description>
        <time_frame>At 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Pembrolizumab, Enobosarm)</title>
            <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Benefit Rate</title>
          <description>Clinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
        <time_frame>Time to death as a result of any cause, assessed up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Pembrolizumab, Enobosarm)</title>
            <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</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="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" lower_limit="10.4" upper_limit="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>Two patients were not evaluable for response, and were excluded from progression-free survival.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Pembrolizumab, Enobosarm)</title>
            <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.</description>
          <population>Two patients were not evaluable for response, and were excluded from progression-free survival.</population>
          <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="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.9" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>36 months from commencement of treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Pembrolizumab, Enobosarm)</title>
          <description>Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
Enobosarm: Given PO&#xD;
Laboratory Biomarker Analysis: Correlative studies&#xD;
Pembrolizumab: Given IV</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE 4.0</default_vocab>
        <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="8" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>10019279-Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>10021038-Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>10016750-Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>10001409-Adult respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013963-Dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE 4.0</default_vocab>
        <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="18" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>10002272-Anemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>10033557-Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10040741-Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10040752-Sinus tachycardia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>bradypnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>10014020-Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>10001367-Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020850-Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021114-Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>10005886-Blurred vision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>eye discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>10000060-Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10000081-Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10005265-Bloating</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10010774-Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10012318-Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10012727-Diarrhea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013781-Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013946-Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013950-Dysphagia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10015388-Esophageal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10016766-Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10017999-Gastrointestinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10028813-Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10047700-Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>10008531-Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10011914-Death NOS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10014222-Edema face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10016059-Facial pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10016256-Fatigue</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10016558-Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10017577-Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10022095-Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10033371-Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10050068-Edema limbs</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10062466-Localized edema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10062501-Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DROWSINESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>10001718-Allergic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>10005047-Bladder infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10046300-Upper respiratory infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10046571-Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10048038-Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>stomach flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>10016173-Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10041569-Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>10001551-Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10003481-Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10008661-Cholesterol high</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10011368-Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10025256-Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10029366-Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10035528-Platelet count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10047896-Weight gain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10047900-Weight loss</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10049182-White blood cell decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>10002646-Anorexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020639-Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020647-Hyperkalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020943-Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020949-Hypocalcemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021005-Hypoglycemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021018-Hypokalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021028-Hypomagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021038-Hyponatremia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021059-Hypophosphatemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASED TRIGLYCERIDES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>10003239-Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10003988-Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10006002-Bone pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10008496-Chest wall pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10016750-Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10028411-Myalgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10028836-Neck pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10033425-Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10062572-Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GENERALIZED MSK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT HIP PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT KNEE PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT THIGH PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>increased muscle mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>muscle spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>muscle spasms (back)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>actinic keratosis, hyperplastic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>progressive disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>10013573-Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013911-Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10019211-Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020765-Hypersomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10024264-Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10034620-Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10041349-Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10044565-Tremor</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>10002855-Anxiety</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10012378-Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10022437-Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10024419-Libido decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>10019450-Hematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10037032-Proteinuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10046539-Urinary frequency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10046593-Urinary urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10061574-Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10063057-Cystitis noninfective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>oliguria (mild)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>10006298-Breast pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10046904-Vaginal dryness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>10003504-Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10011224-Cough</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013963-Dyspnea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10015090-Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021143-Hypoxia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10028735-Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10035598-Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10036402-Postnasal drip</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10036790-Productive cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10041367-Sore throat</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10047924-Wheezing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OBSTRUCTIVE PNEUMONIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>bilateral pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>hemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>rhonchi breath sounds</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>10001760-Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10013786-Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020642-Hyperhidrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10033474-Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10037087-Pruritus</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10037847-Rash acneiform</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10037868-Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10054541-Periorbital edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>stent placement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>10016825-Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020407-Hot flashes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10020772-Hypertension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10021097-Hypotension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10025233-Lymphedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10042554-Superficial thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>10043565-Thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The trial was stopped early because of the withdrawal of GTx-024 drug supply. Full assessment of activity could not be completed as planned.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Yuan Yuan, MD, PhD.</name_or_title>
      <organization>Department of Medical Oncology, City of Hope</organization>
      <phone>626-256-4673 ext 89200</phone>
      <email>yuyuan@coh.org</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/NCT02971761
org study id: 16131
secondary id: NCI-2016-01759
secondary id: 16131
nct id: NCT02971761
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in
      treating patients with androgen receptor positive triple negative breast cancer that has
      spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies,
      such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere
      with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast
      cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of
      androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than
      pembrolizumab alone in treating patients with androgen receptor positive triple negative
      breast cancer.
PRIMARY OBJECTIVES:

      I. To evaluate the safety/tolerability of the combination regimen. II. To determine the
      response rate (complete response [CR] or partial response [PR] via Response Evaluation
      Criteria in Solid Tumors [RECIST] 1.1) of the combination of pembrolizumab with enobosarm
      (GTx-024) in patients with advanced androgen receptor (AR) positive (+) triple negative
      breast cancer (TNBC).

      SECONDARY OBJECTIVES:

      I. To evaluate clinical outcomes by RECIST 1.1 including clinical benefit rate (CBR) at 24
      weeks, progression free-survival (PFS), duration of response (DOR), event free survival
      (EFS), time-to-treatment failure (TTF); and overall survival (OS).

      II. To evaluate the role of immune-related response criteria (irRECIST). III. To evaluate the
      association of AR by immunohistochemistry (IHC) and clinical response.

      EXPLORATORY OBJECTIVES:

      I. To evaluate the association of an AR gene expression signature and clinical response.

      II. To evaluate genomic and phenotypic status of breast tumor. III. To evaluate the effect of
      the combination therapy on peripheral blood circulating tumor cells (CTCs) and circulating
      tumor deoxyribonucleic acid (DNA) (ctDNA).

      IV. To evaluate the effect of combination therapy on tumor-derived exosomes (TEX) and TEX
      associated immune biomarkers.

      V. Immune correlatives:

      Va. To evaluate pre-treatment programmed death ligand 1 (PD-L1) and tumor infiltrating
      lymphocytes (TILs) as a predictor of response to combination therapy.

      Vb. To evaluate specific TIL subsets (e.g. CD4, CD8, regulatory T cell [Treg] distribution)
      and other immunological correlatives (e.g. T cell receptor [TCR] repertoire analysis) as
      possible predictors of response.

      Vc. To evaluate change in TILs as a result of the combination therapy. Vd. To evaluate
      peripheral blood, immune biomarkers.

      OUTLINE:

      Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and enobosarm
      orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 35 cycles
      in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 and 90 days, every 3
      months, and bi-annually.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rate (Complete Response or Partial Response)
time frame: Up to 36 months
description: Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
measure: Progression-free Survival
time frame: Time to disease progression/relapse or death as a result of any cause, assessed up to 36 months
description: Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
measure: Clinical Benefit Rate
time frame: At 16 weeks
description: Clinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1.
measure: Overall Survival
time frame: Time to death as a result of any cause, assessed up to 36 months
description: Overall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
measure: Progression-free Survival
time frame: Up to 1 year
description: Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
arm group label: Treatment (pembrolizumab, enobosarm)
arm group type: Experimental
description: Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Enobosarm
description: Given PO
arm group label: Treatment (pembrolizumab, enobosarm)
other name: Gtx-024
other name: Ostarine
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (pembrolizumab, enobosarm)
intervention type: Biological
intervention name: Pembrolizumab
description: Given IV
arm group label: Treatment (pembrolizumab, enobosarm)
other name: Keytruda
other name: Lambrolizumab
other name: MK-3475
other name: SCH 900475
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuan Yuan
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Pembrolizumab
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The trial was stopped early because of the withdrawal of GTx-024 drug supply. Full assessment of activity could not be completed as planned.
point of contact: 