<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/NCT04428151</url>
  </required_header>
  <id_info>
    <org_study_id>7902-009</org_study_id>
    <secondary_id>LEAP-009</secondary_id>
    <secondary_id>E7080-G000-228</secondary_id>
    <secondary_id>MK-7902-009</secondary_id>
    <secondary_id>2019-000569-19</secondary_id>
    <nct_id>NCT04428151</nct_id>
  </id_info>
  <brief_title>Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)</brief_title>
  <official_title>A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</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 study is designed to assess the safety and efficacy of lenvatinib in combination with&#xD;
      pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and&#xD;
      efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck&#xD;
      squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a&#xD;
      programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor.&#xD;
      The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy&#xD;
      with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as&#xD;
      assessed by blinded independent central review.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Anticipated">August 18, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 18, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>OS is defined as the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>DOR is defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified RECIST 1.1 as assessed by BICR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced One or More Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Squamous Cell Carcinoma of Head and Neck</condition>
  <arm_group>
    <arm_group_label>Lenvatinib + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC Chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lenvatinib Monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>20 mg once daily, taken as oral capsules</description>
    <arm_group_label>Lenvatinib + Pembrolizumab</arm_group_label>
    <other_name>LENVIMA®</other_name>
    <other_name>MK-7902</other_name>
    <other_name>E7080</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>200 mg 30-minute IV infusion on day 1 of each 21-day cycle</description>
    <arm_group_label>Lenvatinib + Pembrolizumab</arm_group_label>
    <other_name>KEYTRUDA®</other_name>
    <other_name>MK-3475</other_name>
    <other_name>SCH 900475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>75 mg/m^2 administered as an IV infusion on day 1 of each 21-day cycle</description>
    <arm_group_label>SOC Chemotherapy</arm_group_label>
    <other_name>TAXOTERE®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>1250 mg/m^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets</description>
    <arm_group_label>SOC Chemotherapy</arm_group_label>
    <other_name>Xeloda®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>80 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle</description>
    <arm_group_label>SOC Chemotherapy</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <description>400 mg/m^2 loading dose, followed by 250 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle</description>
    <arm_group_label>SOC Chemotherapy</arm_group_label>
    <other_name>ERBITUX®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>24 mg once daily, taken as oral capsules</description>
    <arm_group_label>Lenvatinib Monotherapy</arm_group_label>
    <other_name>LENVIMA®</other_name>
    <other_name>MK-7902</other_name>
    <other_name>E7080</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed recurrent (not amenable to curative treatment with local&#xD;
             and/or systemic therapies) or metastatic (disseminated) HNSCC of the oral cavity,&#xD;
             oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies&#xD;
&#xD;
          -  Disease progression at any time during or after treatment with a platinum-containing&#xD;
             (e.g., carboplatin or cisplatin) regimen&#xD;
&#xD;
          -  Disease progression on or after treatment with an anti-PD-1/PD-L1 mAb (programmed cell&#xD;
             death protein 1/programmed death-ligand 1 monoclonal antibody)&#xD;
&#xD;
          -  Pre-study imaging that demonstrates evidence of disease progression based on&#xD;
             investigator review of at least 2 pre-study images per RECIST 1.1, following&#xD;
             initiation of treatment with a PD-1/PD-L1 inhibitor&#xD;
&#xD;
          -  Measurable disease by CT or MRI based on Response Criteria in Solid Tumors Version 1.1&#xD;
             (RECIST 1.1) as verified by blinded independent central review (BICR). Tumor lesions&#xD;
             situated in a previously irradiated area are considered measurable if progression has&#xD;
             been demonstrated in such lesions&#xD;
&#xD;
          -  ECOG performance status of 0 or 1 assessed within 7 days of the first dose of study&#xD;
             intervention&#xD;
&#xD;
          -  Male participants are eligible to participate if they agree to the following during&#xD;
             the intervention period and for at least 1 week after the last dose of lenvatinib, 3&#xD;
             months after the last dose of capecitabine and paclitaxel, and and 6 months after the&#xD;
             last dose of docetaxel:&#xD;
&#xD;
               -  Refrain from donating sperm&#xD;
&#xD;
               -  Be abstinent from heterosexual intercourse as their preferred and usual lifestyle&#xD;
                  (abstinent on a long term and persistent basis) and agree to remain abstinent; or&#xD;
                  must agree to use contraception unless confirmed to be azoospermic&#xD;
&#xD;
               -  Contraceptive use by men should be consistent with local regulations regarding&#xD;
                  the methods of contraception for those participating in clinical studies&#xD;
&#xD;
          -  A female participant is eligible to participate if she is not pregnant or&#xD;
             breastfeeding, and at least one of the following conditions applies:&#xD;
&#xD;
               -  Is not a woman of childbearing potential (WOCBP)&#xD;
&#xD;
               -  Is a WOCBP and using a contraceptive method that is highly effective (with a&#xD;
                  failure rate of &lt;1% per year), with low user dependency or be abstinent from&#xD;
                  heterosexual intercourse as their preferred and usual lifestyle (abstinent on a&#xD;
                  long term and persistent basis), during the intervention period and for at least&#xD;
                  120 days post pembrolizumab or 1 month post lenvatinib, whichever occurs last&#xD;
                  (Arms 1 and 3), or during the intervention period and for at least 6 months after&#xD;
                  the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last&#xD;
                  dose of cetuximab (Arm 2)&#xD;
&#xD;
               -  Female participants who randomize to Arm 2 must also agree not to donate or&#xD;
                  freeze/store eggs during the intervention period and for at least 6 months after&#xD;
                  the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last&#xD;
                  dose of cetuximab&#xD;
&#xD;
          -  Adequately controlled blood pressure (BP) with or without antihypertensive medications&#xD;
&#xD;
          -  Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they&#xD;
             have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have&#xD;
             undetectable HBV viral load prior to randomization&#xD;
&#xD;
          -  Participants with history of hepatitis C virus (HCV) infection are eligible if HCV&#xD;
             viral load is undetectable at screening&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease that is suitable for local therapy administered with curative intent&#xD;
&#xD;
          -  Life expectancy of less than 3 months and/or has rapidly progressing disease in the&#xD;
             opinion of the treating investigator&#xD;
&#xD;
          -  History of (noninfectious) pneumonitis/interstitial lung disease that required&#xD;
             steroids, or has current pneumonitis/interstitial lung disease&#xD;
&#xD;
          -  Active infection requiring systemic therapy&#xD;
&#xD;
          -  Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in&#xD;
             dosing exceeding 10 mg daily of prednisone equivalent) or any other form of&#xD;
             immunosuppressive therapy within 7 days prior to the first dose of study drug&#xD;
&#xD;
          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis&#xD;
&#xD;
          -  Known additional malignancy that is progressing or has required active systemic&#xD;
             treatment within the past 3 years, except basal cell carcinoma of the skin, squamous&#xD;
             cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ that have&#xD;
             undergone potentially curative therapy&#xD;
&#xD;
          -  Active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
&#xD;
          -  Had an allogeneic tissue/solid organ transplant&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  History of any contraindication or has a severe hypersensitivity to any components of&#xD;
             pembrolizumab, lenvatinib or SOC chemotherapy.&#xD;
&#xD;
          -  Pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula&#xD;
&#xD;
          -  History of a gastrointestinal malabsorption or any other condition or procedure that&#xD;
             may affect oral study drug absorption&#xD;
&#xD;
          -  Had major surgery within 3 weeks prior to first dose of study interventions&#xD;
&#xD;
          -  Clinically significant cardiovascular impairment within 12 months of the first dose of&#xD;
             study drug&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Has difficulty swallowing capsules or ingesting a suspension orally, or by a feeding&#xD;
             tube&#xD;
&#xD;
          -  Prior treatment with lenvatinib&#xD;
&#xD;
          -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2&#xD;
             weeks prior to Study Day 1 or has not recovered from adverse events (AEs) due to a&#xD;
             previously administered agent. Participants with endocrine-related AEs Grade ≤2&#xD;
             requiring treatment or hormone replacement may be eligible&#xD;
&#xD;
          -  Has received a live or live attenuated vaccine within 30 days prior to the first dose&#xD;
             of study intervention. Note: Administration of killed vaccines is allowed&#xD;
&#xD;
          -  Previously treated with 4 or more systemic regimens given for recurrent/metastatic&#xD;
             disease&#xD;
&#xD;
          -  Has received an investigational agent or has used an investigational device within 4&#xD;
             weeks prior to study intervention administration&#xD;
&#xD;
          -  Known psychiatric or substance abuse disorder that would interfere with the&#xD;
             participant's ability to cooperate with the requirements of the study&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Toll Free Number</last_name>
    <phone>1-888-577-8839</phone>
    <email>Trialsites@merck.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope ( Site 1519)</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>626-256-4673</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>310-794-4955</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>203-737-7981</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UF Health ( Site 1554)</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>352-265-0725</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mid Florida Hematology and Oncology Center ( Site 1606)</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>386-774-1223</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida ( Site 1596)</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>786-413-9673</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Georgia Cancer Center at Augusta University ( Site 1575)</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>770-812-1928</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beacon Cancer Care ( Site 1599)</name>
      <address>
        <city>Post Falls</city>
        <state>Idaho</state>
        <zip>83854</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>208-755-2408</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center ( Site 1560)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>312-563-8756</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612)</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>765-751-5850</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Iowa ( Site 1572)</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>319-335-3500</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center ( Site 1538)</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>913-588-1227</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>502-394-6350</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>225-215-1185</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Maryland Greenebaum Cancer Center ( Site 1522)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>410-328-2703</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center ( Site 1605)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>617-638-8265</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Chan Medical School ( Site 1616)</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>508-856-3216</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System ( Site 1584)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>734-769-7100</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute ( Site 1566)</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>313-576-8778</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System ( Site 1544)</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>313-916-2600</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic ( Site 1515)</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625)</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>601-355-2485</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine ( Site 1500)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Vincent Frontier Cancer Center ( Site 1507)</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>406-238-6290</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Of Nebraska Medical Center ( Site 1570)</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey ( Site 1523)</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903-2681</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>732-427-7394</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center ( Site 1582)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute ( Site 1590)</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Institute ( Site 1541)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>919-681-4768</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati ( Site 1567)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>513-584-7698</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Cleveland ( Site 1578)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>216-844-3951</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic ( Site 1598)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>866-223-8100</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>614-685-2039</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gettysburg Cancer Center ( Site 1594)</name>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <zip>17325</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center ( Site 1561)</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>717-531-5471</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center ( Site 1502)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>215-214-1515</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina ( Site 1579)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>843-792-9321</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Francis Cancer Center-Research Office ( Site 1607)</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>864-603-6300</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Center For Cancer And Blood Disorders ( Site 1569)</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists ( Site 1621)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>801-462-1053</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute ( Site 1532)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>801-581-2121</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute ( Site 1550)</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031-4867</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>571-472-0624</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Fredericksburg ( Site 1537)</name>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <zip>22408</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>540-371-0079 X360</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609)</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>253-403-0791</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin Clinical Cancer Center ( Site 1574)</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>414-805-4600</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Blacktown Hospital ( Site 0101)</name>
      <address>
        <city>Blacktown</city>
        <state>New South Wales</state>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61402348016</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mid North Coast Cancer Institute ( Site 0109)</name>
      <address>
        <city>Port Macquarie</city>
        <state>New South Wales</state>
        <zip>2444</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gallipoli Medical Research Foundation-GMRF CTU ( Site 0105)</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61733947284</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Townsville Hospital ( Site 0107)</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61744331111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital ( Site 0110)</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>(08) 70742342</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Monash Health ( Site 0102)</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61385722392</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre ( Site 0304)</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>4035213093</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>BC Cancer-Vancouver Center ( Site 0306)</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instituto de Cancerología ( Site 0408)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050025</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>3409393 EXT 5414</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)</name>
      <address>
        <city>Valledupar</city>
        <state>Cesar</state>
        <zip>200001</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>57 3157411877</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oncomédica S.A.S ( Site 0409)</name>
      <address>
        <city>Montería</city>
        <state>Cordoba</state>
        <zip>230002</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>3105394868</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Administradora Country S.A.S - Clínica del Country ( Site 0407)</name>
      <address>
        <city>Bogotá</city>
        <state>Cundinamarca</state>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>3005725172</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet University Hospital Copenhagen ( Site 1000)</name>
      <address>
        <city>Copenhagen</city>
        <state>Hovedstaden</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4535453545</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital La Timone ( Site 0503)</name>
      <address>
        <city>Marseille</city>
        <state>Bouches-du-Rhone</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33491385708</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de Cancerologie du Grand Montpellier ( Site 0508)</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34070</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33467926155</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Puy-de-Dome</state>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>33473278141</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)</name>
      <address>
        <city>Rouen</city>
        <state>Seine-Maritime</state>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>33146252410</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy ( Site 0505)</name>
      <address>
        <city>Villejuif</city>
        <state>Val-de-Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33142114637</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Curie ( Site 0500)</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>33144324086</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center-Oncology ( Site 0604)</name>
      <address>
        <city>Be'er Sheva</city>
        <zip>8400000</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>97286400189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus-Oncology Division ( Site 0602)</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+972502061161</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center. Ein Kerem ( Site 0601)</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+972508946244</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center ( Site 0600)</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital ( Site 1801)</name>
      <address>
        <city>Seongnam</city>
        <state>Kyonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+82317877084</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital ( Site 1802)</name>
      <address>
        <city>Suwon</city>
        <state>Kyonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System ( Site 1800)</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+8215991004</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center ( Site 1803)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+82234106489</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oslo universitetssykehus, Radiumhospitalet ( Site 1102)</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4722934000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401)</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <state>Porto</state>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+351227865100</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+351225084000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Colțea ( Site 1708)</name>
      <address>
        <city>București</city>
        <state>Bucuresti</state>
        <zip>030171</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>40722559551</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiomed SRL Cluj-Napoca ( Site 1701)</name>
      <address>
        <city>Cluj Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40721254415</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)</name>
      <address>
        <city>Cluj Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4026459831</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)</name>
      <address>
        <city>Floresti</city>
        <state>Cluj</state>
        <zip>407280</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>40742206212</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704)</name>
      <address>
        <city>Craiova</city>
        <state>Dolj</state>
        <zip>200542</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40727774974</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet Medical Oncomed ( Site 1707)</name>
      <address>
        <city>Timișoara</city>
        <state>Timis</state>
        <zip>300239</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40745100495</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>S.C.Focus Lab Plus S.R.L ( Site 1703)</name>
      <address>
        <city>Bucuresti</city>
        <zip>022548</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40721298677</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34934014105</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34 93 227 54 02</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico de Galicia ( Site 0706)</name>
      <address>
        <city>A Coruna</city>
        <state>Galicia</state>
        <zip>15009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>981287499</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General de Valencia ( Site 0703)</name>
      <address>
        <city>Valencia</city>
        <state>Valenciana, Comunitat</state>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34963187527</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d Hebron ( Site 0701)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal ( Site 0705)</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34913368263</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria ( Site 0702)</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34952270497</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)</name>
      <address>
        <city>Taoyuan County</city>
        <state>Taoyuan</state>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+88633281200</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Kaohsiung ( Site 1204)</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+88677317123</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital ( Site 1205)</name>
      <address>
        <city>Taichung</city>
        <zip>404332</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>8864220521215050</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital ( Site 1206)</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>886-4-23592525</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital ( Site 1202)</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+8866235-3535</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital ( Site 1200)</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>886-2-23123456#67510</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital ( Site 1201)</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>886-2-28267000 #7911</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary ( Site 0911)</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeen City</state>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>01224 553876</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital ( Site 0910)</name>
      <address>
        <city>Cottingham</city>
        <state>East Riding Of Yorkshire</state>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Beatson West of Scotland Cancer Centre ( Site 0909)</name>
      <address>
        <city>Glasgow</city>
        <state>Glasgow City</state>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+441413017070</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)</name>
      <address>
        <city>London</city>
        <state>Great Britain</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+442071882018</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust ( Site 0905)</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>02380777222</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital ( Site 0902)</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>00441227866393</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital ( Site 0908)</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Musgrove Park Hospital ( Site 0904)</name>
      <address>
        <city>Taunton</city>
        <state>Somerset</state>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>01823333444</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital. ( Site 0901)</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>00441227866393</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust ( Site 0907)</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+441614463317</phone>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Israel</country>
    <country>Korea, Republic of</country>
    <country>Norway</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.merckclinicaltrials.com/</url>
    <description>Merck Clinical Trials Information</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Programmed Cell Death-1 (PD1, PD-1)</keyword>
  <keyword>Programmed Death-Ligand 1 (PDL1, PD-L1)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Lenvatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </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/NCT04428151
org study id: 7902-009
secondary id: LEAP-009
secondary id: E7080-G000-228
secondary id: MK-7902-009
secondary id: 2019-000569-19
nct id: NCT04428151
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to assess the safety and efficacy of lenvatinib in combination with
      pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
      efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck
      squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a
      programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor.
      The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy
      with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as
      assessed by blinded independent central review.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Up to approximately 4 years
description: ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
measure: Progression-Free Survival (PFS)
time frame: Up to approximately 4 years
description: PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
measure: Overall Survival (OS)
time frame: Up to approximately 4 years
description: OS is defined as the time from randomization to death due to any cause.
measure: Duration of Response (DOR)
time frame: Up to approximately 4 years
description: DOR is defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified RECIST 1.1 as assessed by BICR.
measure: Number of Participants Who Experienced One or More Adverse Events (AEs)
time frame: Up to approximately 4 years
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
measure: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
time frame: Up to approximately 4 years
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
arm group label: Lenvatinib + Pembrolizumab
arm group type: Experimental
description: Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.
arm group label: SOC Chemotherapy
arm group type: Active Comparator
description: Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
arm group label: Lenvatinib Monotherapy
arm group type: Active Comparator
description: Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
intervention type: Drug
intervention name: Lenvatinib
description: 20 mg once daily, taken as oral capsules
arm group label: Lenvatinib + Pembrolizumab
other name: LENVIMA®
other name: MK-7902
other name: E7080
intervention type: Biological
intervention name: Pembrolizumab
description: 200 mg 30-minute IV infusion on day 1 of each 21-day cycle
arm group label: Lenvatinib + Pembrolizumab
other name: KEYTRUDA®
other name: MK-3475
other name: SCH 900475
intervention type: Drug
intervention name: Docetaxel
description: 75 mg/m^2 administered as an IV infusion on day 1 of each 21-day cycle
arm group label: SOC Chemotherapy
other name: TAXOTERE®
intervention type: Drug
intervention name: Capecitabine
description: 1250 mg/m^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets
arm group label: SOC Chemotherapy
other name: Xeloda®
intervention type: Drug
intervention name: Paclitaxel
description: 80 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
arm group label: SOC Chemotherapy
other name: Taxol
intervention type: Drug
intervention name: Cetuximab
description: 400 mg/m^2 loading dose, followed by 250 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
arm group label: SOC Chemotherapy
other name: ERBITUX®
intervention type: Drug
intervention name: Lenvatinib
description: 24 mg once daily, taken as oral capsules
arm group label: Lenvatinib Monotherapy
other name: LENVIMA®
other name: MK-7902
other name: E7080
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
last name: Toll Free Number
phone: 1-888-577-8839
email: Trialsites@merck.com
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status: Recruiting
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status: Recruiting
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status: Completed
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status: Recruiting
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status: Completed
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status: Recruiting
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status: Active, not recruiting
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status: Completed
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status: Completed
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status: Recruiting
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Completed
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Completed
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status: Recruiting
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status: Recruiting
contact: 
country: Australia
country: Canada
country: Colombia
country: Denmark
country: France
country: Israel
country: Korea, Republic of
country: Norway
country: Portugal
country: Romania
country: Spain
country: Taiwan
country: United Kingdom
country: United States
url: https://www.merckclinicaltrials.com/
description: Merck Clinical Trials Information
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Paclitaxel
mesh term: Docetaxel
mesh term: Pembrolizumab
mesh term: Capecitabine
mesh term: Cetuximab
mesh term: Lenvatinib
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php