<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/NCT03765918</url>
  </required_header>
  <id_info>
    <org_study_id>3475-689</org_study_id>
    <secondary_id>MK-3475-689</secondary_id>
    <secondary_id>2022-500254-41-00</secondary_id>
    <secondary_id>2017-001139-38</secondary_id>
    <nct_id>NCT03765918</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)</brief_title>
  <official_title>A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given&#xD;
      prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or&#xD;
      without cisplatin), as post-surgical therapy in treatment naïve participants with newly&#xD;
      diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell&#xD;
      carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1&#xD;
      (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab&#xD;
      given before surgery and after surgery in combination with radiotherapy (with or without&#xD;
      cisplatin) improves major pathological response and event-free survival compared to&#xD;
      radiotherapy (with or without cisplatin) given after surgery alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2025</primary_completion_date>
  <phase>Phase 3</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>Major Pathological Response (mPR)</measure>
    <time_frame>Up to 30 days post-sugery</time_frame>
    <description>The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event-free Survival (EFS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>OS is the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological Complete Response (pCR)</measure>
    <time_frame>Up to 30 days post-sugery</time_frame>
    <description>Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)</measure>
    <time_frame>Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to 5 years)</time_frame>
    <description>Change from baseline in the combined score of GHS/QoL using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 29 and 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Health Status/Physical Functioning Scales</measure>
    <time_frame>Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to 5 years)</time_frame>
    <description>Change from baseline in the combined score of physical functioning scale using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 1 through 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Swallowing, Speech, and Pain Symptoms</measure>
    <time_frame>Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to 5 years)</time_frame>
    <description>Change from baseline in the combined score of swallowing, speech, and pain symptoms using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&amp;N35) items 31-38, 46, and 53-54</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing An Adverse Event (AEs)</measure>
    <time_frame>From time of first dose of study treatment until the end of follow-up (up to 5 years)</time_frame>
    <description>Percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Discontinuing Study Drug Due to AEs</measure>
    <time_frame>From time of first dose of study treatment until the end of treatment (up to 12 months)</time_frame>
    <description>Percentage of participants discontinuing study drug due to an AE</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">704</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Pembro Neoadjuvant+Pembro SOC Adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Neoadjuvant+SOC Adjuvant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive no neoadjuvant prior to surgery. Following surgical resection, high risk participants receive standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive standard of care radiotherapy as adjuvant therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab 200 mg</intervention_name>
    <description>200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Pembro Neoadjuvant+Pembro SOC Adjuvant</arm_group_label>
    <other_name>KEYTRUDA®</other_name>
    <other_name>MK-3475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy 60 Gray/day</intervention_name>
    <description>Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.</description>
    <arm_group_label>No Neoadjuvant+SOC Adjuvant</arm_group_label>
    <arm_group_label>Pembro Neoadjuvant+Pembro SOC Adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy 66 Gray/day</intervention_name>
    <description>High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.</description>
    <arm_group_label>No Neoadjuvant+SOC Adjuvant</arm_group_label>
    <arm_group_label>Pembro Neoadjuvant+Pembro SOC Adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy 70 Gray/day</intervention_name>
    <description>Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.</description>
    <arm_group_label>No Neoadjuvant+SOC Adjuvant</arm_group_label>
    <arm_group_label>Pembro Neoadjuvant+Pembro SOC Adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin 100 mg/m^2</intervention_name>
    <description>100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>No Neoadjuvant+SOC Adjuvant</arm_group_label>
    <arm_group_label>Pembro Neoadjuvant+Pembro SOC Adjuvant</arm_group_label>
    <other_name>Platinol®</other_name>
    <other_name>Platinol-AQ®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous&#xD;
             cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive&#xD;
             oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no&#xD;
             distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or&#xD;
             IVA larynx/hypopharynx/oral cavity primaries.&#xD;
&#xD;
          -  Is eligible for primary surgery based on investigator decision and per local practice&#xD;
&#xD;
          -  Female and male participants of reproductive potential must agree to use adequate&#xD;
             contraception throughout the study period and for up to 180 days after the last dose&#xD;
             of study therapy.&#xD;
&#xD;
          -  Male participants must refrain from donating sperm throughout the study period and for&#xD;
             up to 180 days after the last dose of study therapy&#xD;
&#xD;
          -  Female participant that is not pregnant or breastfeeding&#xD;
&#xD;
          -  Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed&#xD;
             by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST&#xD;
             version 1.1&#xD;
&#xD;
          -  Has provided newly obtained core or excisional biopsy of a tumor lesion not previously&#xD;
             irradiated&#xD;
&#xD;
          -  Has results from testing of HPV status for oropharyngeal cancer defined as p16&#xD;
&#xD;
          -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed&#xD;
             within 10 days of randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has Stage T4B and/or N3 LA HNSCC and/or distant metastases&#xD;
&#xD;
          -  Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as&#xD;
             nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer&#xD;
             (HNC)&#xD;
&#xD;
          -  Female participant who has a positive urine pregnancy test within 72 hours prior to&#xD;
             study start or within 24 hours prior to the start of radiotherapy with or without&#xD;
             cisplatin.&#xD;
&#xD;
          -  Has received prior therapy with an anti-programmed cell death receptor 1(PD-1),&#xD;
             anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death&#xD;
             receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory&#xD;
             T-cell receptor&#xD;
&#xD;
          -  Has received prior radiotherapy treatment or systemic anti-cancer therapy including&#xD;
             investigational agents for the HNC under study prior to study start&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to randomization&#xD;
&#xD;
          -  Is currently participating in or has participated in a study of an investigational&#xD;
             agent or has used an investigational device within 4 weeks prior to randomization&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving 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 randomization&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or has required active treatment&#xD;
             within the past 3 years with the exception of basal cell carcinoma of the skin,&#xD;
             squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical&#xD;
             cancer or breast carcinoma) that have undergone potentially curative therapy&#xD;
&#xD;
          -  Has radiographically detectable (even if asymptomatic and/or previously treated)&#xD;
             central nervous system metastases and/or carcinomatous meningitis&#xD;
&#xD;
          -  Has Grade ≥2 audiometric hearing loss&#xD;
&#xD;
          -  Has Grade ≥2 neuropathy&#xD;
&#xD;
          -  Has Grade 3-4 bleeding due to the underlying malignancy&#xD;
&#xD;
          -  Has received major surgery or has not recovered adequately from the toxicity and/or&#xD;
             complications from the intervention prior to study start&#xD;
&#xD;
          -  Has had previous allogeneic tissue/solid organ transplant&#xD;
&#xD;
          -  Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients,&#xD;
             radiotherapy, cisplatin or their analogs&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis that required steroids or has current&#xD;
             pneumonitis&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy&#xD;
&#xD;
          -  Has a known history of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface&#xD;
             antigen [HBsAg] reactive) or known active Hepatitis C (defined as Hepatitis C virus&#xD;
             [HCV] ribonucleic acid is detected).&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the study, interfere with the participant's&#xD;
             participation for the full duration of the study, or is not in the best interest of&#xD;
             the participant to participate, in the opinion of the investigator&#xD;
&#xD;
          -  Has a 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>Moores Cancer Center ( Site 1885)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0698</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>858-534-6161</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Southern California Norris Comprehensive Cancer Center ( Site 1850)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hoag Memoriall Hospital Presbyterian ( Site 2056)</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92688</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>949-764-5347</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UC Davis Health System ( Site 1864)</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>916-734-8452</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare ( Site 1806)</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>707-521-3836</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center ( Site 1838)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>720-848-0702</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center ( Site 2062)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>202-877-9386</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>George Washington University Medical Faculty Associates ( Site 2035)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Florida ( Site 1832)</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando-AdventHealth Medical Group Hematology &amp; Oncology at Orlando ( Site 2054)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>407-303-2024</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orlando Health Cancer Institute ( Site 2061)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>321-841-4348</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Regional Medical Center ( Site 2021)</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Beacon Cancer Care ( Site 2052)</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 1823)</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>312-942-8004</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem ( Site 1812)</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>847-570-2109</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center [Maywood, IL] ( Site 1817)</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>708-327-3236</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center ( Site 2004)</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>859-257-9568</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ochsner Cancer Institute ( Site 2045)</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland ( Site 2031)</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>410-328-6373</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Center ( Site 1873)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>617-582-9571</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center ( Site 1875)</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute ( Site 1870)</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>800-527-6266</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System ( Site 1803)</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>313-916-1049</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>573-884-6011</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine ( Site 1800)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>314-747-8378</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Vincent Healthcare Frontier Cancer Center ( Site 1818)</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>MSKCC-Bergen ( Site 2037)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey ( Site 2071)</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>908-531-4291</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>908-531-4291</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of New Mexico Comprehensive Cancer Center ( Site 1882)</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Montefiore Einstein Center ( Site 2028)</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>718-405-8027</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Erie County Medical Center ( Site 2047)</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>716-898-3698</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Monter Cancer Center ( Site 2060)</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>917-434-3043</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>212-731-6465</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center ( Site 1857)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College ( Site 2050)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>646-962-6200</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northwell Health Cancer Institute ( Site 2030)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>212-434-3644</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stony Brook University ( Site 2063)</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-444-8410</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>631-623-4272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute ( Site 2003)</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest Compenhensive Cancer Center ( Site 2029)</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27357</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sanford Health Roger Maris Cancer Center ( Site 2034)</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>701-234-2441</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospitals ( Site 2032)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Ohio State University ( Site 2012)</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center ( Site 1843)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97220</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>503-215-5696</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health Science University ( Site 1871)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Health Network ( Site 1801)</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>484-503-4156</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>215-240-0748</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital ( Site 1833)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>412-330-6129</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Oncology Clinic ( Site 1859)</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>605-328-1365</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Avera Cancer Institute- Research ( Site 2070)</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>605-838-5945</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Joyce Cancer Clinic ( Site 1827)</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center ( Site 1841)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>USA Clinical Trials ( Site 2068)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>210-249-4819</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah, Huntsman Cancer Institute ( Site 1855)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5550</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>801-587-5562</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center ( Site 2009)</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>802-656-9442</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UVA Health System - Emily Couric Cancer Center ( Site 1826)</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>434-924-1904</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute ( Site 2026)</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>206-606-2048</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Austral ( Site 0009)</name>
      <address>
        <city>Pilar</city>
        <state>Buenos Aires</state>
        <zip>B1629AHJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)</name>
      <address>
        <city>Buenos Aires</city>
        <state>Caba</state>
        <zip>C1431FWO</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>5491157200664</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico de Buenos Aires ( Site 0012)</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <state>Caba</state>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sanatorio Britanico ( Site 0013)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000CVB</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+54 341 420 5500</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Estudios Clinicos-Oncology ( Site 0017)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000DEJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+543412384171</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncologia de Rosario ( Site 0002)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+543414218909</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial del Centenario ( Site 0008)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2002KDS</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5493413702439</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1012</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>5031-9700 ext. 4239</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Aleman Buenos Aires Argentina ( Site 0004)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncología Angel Roffo ( Site 0003)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1417DTB</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)</name>
      <address>
        <city>San Juan</city>
        <zip>J5402DIL</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5402644709367</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women s Hospital ( Site 0050)</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61736468111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)</name>
      <address>
        <city>Linz</city>
        <state>Oberosterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4373276777356</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+433163858353</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+435725525801</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien ( Site 1903)</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4314040044240</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de Jolimont ( Site 0103)</name>
      <address>
        <city>Haine Saint Paul</city>
        <state>Hainaut</state>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3227641992</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UZ Gent ( Site 0101)</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3293322811</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Nikolaas ( Site 0104)</name>
      <address>
        <city>Sint-Niklaas</city>
        <state>Oost-Vlaanderen</state>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3237602683</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40050-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Regional Integrado de Oncologia ( Site 0160)</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60336-232</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)</name>
      <address>
        <city>Ipatinga</city>
        <state>Minas Gerais</state>
        <zip>35162-189</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Liga Norte Riograndense Contra o Cancer ( Site 0171)</name>
      <address>
        <city>Natal</city>
        <state>Rio Grande Do Norte</state>
        <zip>59075-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Nossa Senhora da Conceicao ( Site 0165)</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>91359-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5551993590437</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de Sao Jose de Rio Preto ( Site 0153)</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>Sao Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+551732015154</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20231-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+551138933555</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+551135056698</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute ( Site 0201)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>7804328340</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute ( Site 0211)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>416-480-4617</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre ( Site 0202)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>4169464501</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre ( Site 0210)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>5149341934x53333</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l'Estrie-CHUS ( Site 0209)</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>8193461110x14082</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Arturo Lopez Perez FALP ( Site 0251)</name>
      <address>
        <city>Santiago</city>
        <state>Region M. De Santiago</state>
        <zip>7500921</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+56224457254</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica de la Costa S.A.S. ( Site 0307)</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlantico</state>
        <zip>080020</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+57353369940</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Clinica del Country ( Site 0304)</name>
      <address>
        <city>Bogota</city>
        <state>Distrito Capital De Bogota</state>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oncologos del Occidente S.A. ( Site 0310)</name>
      <address>
        <city>Pereira</city>
        <state>Risaralda</state>
        <zip>661002</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+573215430284</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Medico Imbanaco de Cali S.A ( Site 0300)</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760042</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne ( Site 0351)</name>
      <address>
        <city>Nice</city>
        <state>Alpes-Maritimes</state>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33492031747</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de la Timone ( Site 0356)</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>Institut Claudius Regaud IUCT Oncopole ( Site 0355)</name>
      <address>
        <city>Toulouse</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy ( Site 0353)</name>
      <address>
        <city>Villejuif</city>
        <state>Val-de-Marne</state>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33142116532</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Sainte Catherine ( Site 0352)</name>
      <address>
        <city>Avignon</city>
        <state>Vaucluse</state>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou ( Site 0358)</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Curie ( Site 0350)</name>
      <address>
        <city>Paris</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33144324086</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)</name>
      <address>
        <city>Tuebingen</city>
        <state>Baden-Wurttemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4970712989158</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm ( Site 0402)</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Wurttemberg</state>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4973150059548</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>499318533405</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+498941406969</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Frankfurt ( Site 0403)</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+496963017104</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Kassel GmbH ( Site 0404)</name>
      <address>
        <city>Kassel</city>
        <state>Hessen</state>
        <zip>34125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Koeln ( Site 0413)</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+49 221 478-85775</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein ( Site 0411)</name>
      <address>
        <city>Luebeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4945150042012</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>SRH Wald-Klinikum Gera GmbH ( Site 0406)</name>
      <address>
        <city>Gera</city>
        <state>Thuringen</state>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+491719127522</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Hamburg Eppendorf ( Site 0407)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4940741057122</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)</name>
      <address>
        <city>Pecs</city>
        <state>Baranya</state>
        <zip>7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3672536480</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)</name>
      <address>
        <city>Szolnok</city>
        <state>Jasz-Nagykun-Szolnok</state>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3656503603</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3614752638</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orszagos Onkologiai Intezet ( Site 0454)</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+36122486003209</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. James s Hospital ( Site 0500)</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 8</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3514162164</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus-Oncology Division ( Site 0550)</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 0554)</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>972-2-6776709</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center ( Site 0552)</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4963211</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+97239378044</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center. ( Site 0553)</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+97235302513</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center ( Site 0551)</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital ( Site 0658)</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81527626111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East ( Site 0661)</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81-4-7133-1111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center ( Site 0656)</name>
      <address>
        <city>Akashi</city>
        <state>Hyogo</state>
        <zip>673-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81789291151</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital ( Site 0651)</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa</state>
        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81878985111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital ( Site 0657)</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81457872800</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center ( Site 0652)</name>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81432645431</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center ( Site 0660)</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81925413231</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital ( Site 0655)</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81822575555</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital ( Site 0650)</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81335422511</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University Hospital ( Site 0654)</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81338136111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital ( Site 0659)</name>
      <address>
        <city>Tokyo</city>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+81333426111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital ( Site 0705)</name>
      <address>
        <city>Hwasun Gun</city>
        <state>Jeonranamdo</state>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+82613797633</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cancer Center ( Site 0702)</name>
      <address>
        <city>Goyang-si</city>
        <state>Kyonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea St. Vincent s Hospital ( Site 0704)</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Kyonggi-do</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+82312498153</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital ( Site 0703)</name>
      <address>
        <city>Seongnam-si</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>+82317877037</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System ( Site 0701)</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>+82222288125</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+48606711181</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+48225462208</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Szpitale Pomorskie Sp. z o.o. ( Site 0935)</name>
      <address>
        <city>Gdynia</city>
        <state>Pomorskie</state>
        <zip>81-159</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+48608875140</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)</name>
      <address>
        <city>Gliwice</city>
        <state>Slaskie</state>
        <zip>44101</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+48604077641</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Braga ( Site 0951)</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+351253027000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHLN Hospital Santa Maria ( Site 0952)</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+351217805000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Descobertas ( Site 0953)</name>
      <address>
        <city>Lisboa</city>
        <zip>1998-018</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+351210025200</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)</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>N.N. Blokhin NMRCO ( Site 1005)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan, Respublika</state>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)</name>
      <address>
        <city>Yaroslavl</city>
        <state>Yaroslavskaya Oblast</state>
        <zip>150054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34934978325</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>ICO L Hospitalet ( Site 1208)</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 Clinico Universitario de Santiago ( Site 1207)</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>La Coruna</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34981950511</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Vall D Hebron ( Site 1200)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34932746000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz ( Site 1201)</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34917277516</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio ( Site 1206)</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34955013068</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Zurich ( Site 1923)</name>
      <address>
        <city>Zuerich</city>
        <state>Aargau</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)</name>
      <address>
        <city>Bellinzona</city>
        <state>Ticino</state>
        <zip>6500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+41918113497</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Geneve HUG ( Site 1920)</name>
      <address>
        <city>Geneve</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+41223729881</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+886-7-7317123 ext 3267</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital ( Site 1301)</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+886423592525</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital ( Site 1302)</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+886623535354559</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital ( Site 1300)</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+886223123456</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)</name>
      <address>
        <city>Dnipropetrovsk</city>
        <state>Dnipropetrovska Oblast</state>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Clinical oncology dispensary of Dnipro ( Site 1706)</name>
      <address>
        <city>Dnipro</city>
        <state>Dnipropetrovska Oblast</state>
        <zip>49055</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)</name>
      <address>
        <city>Dnipro</city>
        <state>Dnipropetrovska Oblast</state>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Ukrainian Center of Tomotherapy ( Site 1708)</name>
      <address>
        <city>Kropyvnitskiy</city>
        <state>Kirovohradska Oblast</state>
        <zip>25011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)</name>
      <address>
        <city>Kropyvnytskyi</city>
        <state>Kirovohradska Oblast</state>
        <zip>25006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)</name>
      <address>
        <city>Kapitanivka Village</city>
        <state>Kyivska Oblast</state>
        <zip>08111</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute of the MoH of Ukraine ( Site 1702)</name>
      <address>
        <city>Kyiv</city>
        <state>Kyivska Oblast</state>
        <zip>03022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>LISOD. Hospital ( Site 1707)</name>
      <address>
        <city>Pliuty</city>
        <state>Kyiv</state>
        <zip>08720</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Oncology Centre ( Site 1701)</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's Hospital ( Site 1610)</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 2QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>07837712522</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital ( Site 1601)</name>
      <address>
        <city>Cottingham-Hull</city>
        <state>Kingston Upon Hull</state>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+441482461306</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guy s &amp; St Thomas NHS Foundation Trust ( Site 1604)</name>
      <address>
        <city>London</city>
        <state>London, City Of</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>Royal Marsden Hospital - Fulham Road London ( Site 1609)</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>+442078118311</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+442033118427</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Weston Park Hospital ( Site 1607)</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckclinicaltrials.com</url>
    <description>Merck Clinical Trial Information</description>
  </link>
  <link>
    <url>https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-689&amp;&amp;kw=3475-689</url>
    <description>Plain Language Summary</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PD-1</keyword>
  <keyword>PD1</keyword>
  <keyword>Programmed Cell Death-1</keyword>
  <keyword>Programmed Cell Death 1</keyword>
  <keyword>Programmed Cell Death-Ligand 1 (PD-L1)</keyword>
  <keyword>Programmed Cell Death-Ligand 2 (PD-L2)</keyword>
  <keyword>PDL1</keyword>
  <keyword>PDL2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Pembrolizumab</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/NCT03765918
org study id: 3475-689
secondary id: MK-3475-689
secondary id: 2022-500254-41-00
secondary id: 2017-001139-38
nct id: NCT03765918
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given
      prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or
      without cisplatin), as post-surgical therapy in treatment naïve participants with newly
      diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell
      carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1
      (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab
      given before surgery and after surgery in combination with radiotherapy (with or without
      cisplatin) improves major pathological response and event-free survival compared to
      radiotherapy (with or without cisplatin) given after surgery alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major Pathological Response (mPR)
time frame: Up to 30 days post-sugery
description: The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
measure: Event-free Survival (EFS)
time frame: Up to 5 years
description: EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
measure: Overall Survival (OS)
time frame: Up to 5 years
description: OS is the time from randomization to death due to any cause.
measure: Pathological Complete Response (pCR)
time frame: Up to 30 days post-sugery
description: Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
measure: Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)
time frame: Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to 5 years)
description: Change from baseline in the combined score of GHS/QoL using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 29 and 30
measure: Change From Baseline in Global Health Status/Physical Functioning Scales
time frame: Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to 5 years)
description: Change from baseline in the combined score of physical functioning scale using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 1 through 5
measure: Change from Baseline in Swallowing, Speech, and Pain Symptoms
time frame: Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to 5 years)
description: Change from baseline in the combined score of swallowing, speech, and pain symptoms using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&N35) items 31-38, 46, and 53-54
measure: Percentage of Participants Experiencing An Adverse Event (AEs)
time frame: From time of first dose of study treatment until the end of follow-up (up to 5 years)
description: Percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy
measure: Percentage of Participants Discontinuing Study Drug Due to AEs
time frame: From time of first dose of study treatment until the end of treatment (up to 12 months)
description: Percentage of participants discontinuing study drug due to an AE
arm group label: Pembro Neoadjuvant+Pembro SOC Adjuvant
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy.
arm group label: No Neoadjuvant+SOC Adjuvant
arm group type: Active Comparator
description: Participants receive no neoadjuvant prior to surgery. Following surgical resection, high risk participants receive standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive standard of care radiotherapy as adjuvant therapy.
intervention type: Biological
intervention name: Pembrolizumab 200 mg
description: 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
arm group label: Pembro Neoadjuvant+Pembro SOC Adjuvant
other name: KEYTRUDA®
other name: MK-3475
intervention type: Radiation
intervention name: Radiotherapy 60 Gray/day
description: Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
arm group label: No Neoadjuvant+SOC Adjuvant
arm group label: Pembro Neoadjuvant+Pembro SOC Adjuvant
intervention type: Radiation
intervention name: Radiotherapy 66 Gray/day
description: High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
arm group label: No Neoadjuvant+SOC Adjuvant
arm group label: Pembro Neoadjuvant+Pembro SOC Adjuvant
intervention type: Radiation
intervention name: Radiotherapy 70 Gray/day
description: Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
arm group label: No Neoadjuvant+SOC Adjuvant
arm group label: Pembro Neoadjuvant+Pembro SOC Adjuvant
intervention type: Drug
intervention name: Cisplatin 100 mg/m^2
description: 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle
arm group label: No Neoadjuvant+SOC Adjuvant
arm group label: Pembro Neoadjuvant+Pembro SOC Adjuvant
other name: Platinol®
other name: Platinol-AQ®
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
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Suspended
facility: 
status: Completed
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Completed
facility: 
status: Suspended
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Chile
country: Colombia
country: France
country: Germany
country: Hungary
country: Ireland
country: Israel
country: Japan
country: Korea, Republic of
country: Poland
country: Portugal
country: Russian Federation
country: Spain
country: Switzerland
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
url: http://merckclinicaltrials.com
description: Merck Clinical Trial Information
url: https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-689&&kw=3475-689
description: Plain Language Summary
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Head and Neck Neoplasms
mesh term: Cisplatin
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php