<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/NCT03833167</url>
  </required_header>
  <id_info>
    <org_study_id>3475-630</org_study_id>
    <secondary_id>MK-3475-630</secondary_id>
    <secondary_id>KEYNOTE-630</secondary_id>
    <secondary_id>2018-001974-76</secondary_id>
    <nct_id>NCT03833167</nct_id>
  </id_info>
  <brief_title>Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)</brief_title>
  <official_title>A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)</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, double-blind, study that compares pembrolizumab (MK-3475) with placebo&#xD;
      given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous&#xD;
      cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with&#xD;
      radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in&#xD;
      increasing recurrence free survival (RFS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">September 29, 2028</completion_date>
  <primary_completion_date type="Anticipated">May 5, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>RFS was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>OS is the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score</measure>
    <time_frame>Baseline and up to approximately 60 months</time_frame>
    <description>Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score</measure>
    <time_frame>Baseline and up to approximately 60 months</time_frame>
    <description>Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 63 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 38 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE will be presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">570</enrollment>
  <condition>Carcinoma, Squamous Cell</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab 400 mg</intervention_name>
    <description>Administered by IV infusion on Day 1 of each 42-day cycle</description>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <other_name>KEYTRUDA®</other_name>
    <other_name>MK-3475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered by IV infusion on Day 1 of each 42-day cycle</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary&#xD;
             site of malignancy (metastatic skin involvement from another type of primary cancer or&#xD;
             from an unknown primary cancer is not permitted)&#xD;
&#xD;
          -  Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site&#xD;
             of malignancy&#xD;
&#xD;
          -  Has undergone complete macroscopic resection of all known cSCC disease with or without&#xD;
             microscopic positive margins. For those participants with residual microscopic&#xD;
             positive margin involvement, confirmation that additional re-excision is not possible&#xD;
             must be provided&#xD;
&#xD;
          -  Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and&#xD;
             ≤16 weeks from randomization&#xD;
&#xD;
          -  Has received an adequate post-op dose of RT (either hypofractionated or conventional)&#xD;
&#xD;
          -  Is disease free as assessed by the investigator with complete radiographic staging&#xD;
             assessment ≤28 days from randomization&#xD;
&#xD;
          -  Is not pregnant or breastfeeding&#xD;
&#xD;
          -  Is not a woman of childbearing potential (WOCBP)&#xD;
&#xD;
          -  Has a negative pregnancy test ≤72 hours before the first dose of study intervention.&#xD;
&#xD;
          -  Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed&#xD;
             Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing&#xD;
&#xD;
          -  Has a life expectancy of &gt;3 months&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days&#xD;
             prior to the first dose of study intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease&#xD;
             before randomization&#xD;
&#xD;
          -  Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell&#xD;
             carcinoma) that has not been definitively treated with surgery or radiation; Bowen's&#xD;
             disease; Merkel cell carcinoma; or melanoma&#xD;
&#xD;
          -  Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-&#xD;
             PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent&#xD;
             directed to another co-stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic&#xD;
             T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)&#xD;
&#xD;
          -  Has received prior systemic anticancer therapy including investigational agents for&#xD;
             cSCC ≤4 weeks prior to before start of study intervention.&#xD;
&#xD;
          -  Has not recovered from all radiation-related toxicities and has not had radiation&#xD;
             pneumonitis&#xD;
&#xD;
          -  Has received a live vaccine ≤30 days prior to the first dose of study intervention&#xD;
&#xD;
          -  Has received an investigational agent or has used an investigational device within 4&#xD;
             weeks prior to the first dose of study treatment.&#xD;
&#xD;
          -  Has known additional malignancy that is progressing or has required active treatment&#xD;
             within the past 2 years. Note: Participants with basal cell carcinoma of the skin,&#xD;
             squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ&#xD;
             of the bladder, that have undergone potentially curative therapy are not excluded.&#xD;
             Other exceptions may be considered with Sponsor consultation. Note: Participants with&#xD;
             low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or&#xD;
             T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng/ml) either treated&#xD;
             with definitive intent or untreated in active surveillance that has been stable for&#xD;
             the past year prior to study allocation. Early stage asymptomatic CLL without prior&#xD;
             treatment and without any of the risk features (unmutated IGHV, lymphocytes &gt;15,000μL,&#xD;
             palpable lymph nodes) will be eligible for the study&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
             except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).&#xD;
&#xD;
          -  Has a history of (noninfectious) pneumonitis/interstitial lung disease that required&#xD;
             steroids or has current pneumonitis/interstitial lung disease&#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 hepatitis B (defined as hepatitis B surface antigen [HBsAg]&#xD;
             reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is&#xD;
             detected) infection&#xD;
&#xD;
          -  Is pregnant or breastfeeding or expecting to conceive or father children within the&#xD;
             projected duration of the study, starting with the screening visit through 120 days&#xD;
             after the last dose of study intervention&#xD;
&#xD;
          -  Has had an allogeneic tissue/solid organ transplant&#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>University of South Alabama, Mitchell Cancer Institute ( Site 1562)</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>251-665-8000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>City of Hope Medical Center ( Site 1505)</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>626-218-5822</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center ( Site 1561)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>858-534-3804</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>310-206-3859</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center ( Site 1560)</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>916-734-3604</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center ( Site 1503)</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center ( Site 1506)</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>720-848-0676</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Center at Yale-New Haven ( Site 1507)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>203-737-7981</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Boca Raton Regional Hospital ( Site 1551)</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>UF Health ( Site 1511)</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>352265068087617</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>305-243-2647</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute of Emory University ( Site 1512)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospital and Clinics ( Site 1514)</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>319-467-5827</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kentucky School of Medicine &amp; Hospitals ( Site 1542)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital ( Site 1518)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Center ( Site 1519)</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>617-632-6571</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Monter Cancer Center-Medical Oncology ( Site 1565)</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>516-734-8896</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic ( Site 1541)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>216-444-7552</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center ( Site 1530)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>503-215-2614</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center ( Site 1570)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>412-623-7368</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>MUSC Hollings Cancer Center ( Site 1533)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>843-792-6022</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>West Cancer Center - East Campus ( Site 1535)</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Ingram Cancer Center ( Site 1543)</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>800-811-8480</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Texas-MD Anderson Cancer Center ( Site 1536)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute ( Site 1537)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>801-587-9834</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute ( Site 1538)</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>703-970-6548</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>West Virginia University ( Site 1569)</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>304-598-6727</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1027AAP</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>5491156455799</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado CEMAIC ( Site 0024)</name>
      <address>
        <city>Capital</city>
        <state>Cordoba</state>
        <zip>X5008HHW</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>543514766837</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Estudios Clinicos-Oncology ( Site 0026)</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>+5493469699922</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Oncológico de Rosario ( Site 0003)</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 Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1181ACH</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+541149590200</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CEMIC ( Site 0012)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1431FWO</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5491154939856</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion CIDEA ( Site 0001)</name>
      <address>
        <city>Caba</city>
        <zip>C1121ABE</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+541149615466</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Riojano Integral ( Site 0002)</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300COE</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+543804468748</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Norte ( Site 0023)</name>
      <address>
        <city>Santiago del Estero</city>
        <zip>G4200AWD</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5491165820007</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chris OBrien Lifehouse ( Site 0051)</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61285140922</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lismore Base Hospital ( Site 0050)</name>
      <address>
        <city>Lismore</city>
        <state>New South Wales</state>
        <zip>2480</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61266294559</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orange Health Services ( Site 0053)</name>
      <address>
        <city>Orange</city>
        <state>New South Wales</state>
        <zip>2800</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+0401958122</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital ( Site 0052)</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61294631181</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital ( Site 0054)</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61756872715</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)</name>
      <address>
        <city>Sunshine Coast</city>
        <state>Queensland</state>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+617 5390 6057</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Alfred Health ( Site 0055)</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+61 3 9076 2000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oncocentro Ceara ( Site 0108)</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60135-237</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5585988847459</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Erasto Gaertner ( Site 0101)</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+554133615195</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Tacchini ( Site 0111)</name>
      <address>
        <city>Bento Goncalves</city>
        <state>Rio Grande Do Sul</state>
        <zip>95700-084</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5554345543331125</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)</name>
      <address>
        <city>Ijui</city>
        <state>Rio Grande Do Sul</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+555533319393</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Bruno Born ( Site 0107)</name>
      <address>
        <city>Lajeado</city>
        <state>Rio Grande Do Sul</state>
        <zip>95900-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+5551371475002476</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Vicente de Paulo ( Site 0105)</name>
      <address>
        <city>Passo Fundo</city>
        <state>Rio Grande Do Sul</state>
        <zip>99010-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+555421034130</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20220-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+552132072985</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>A. C. Camargo Cancer Center ( Site 0116)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01509-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+55 11 994270884</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Center ( Site 0161)</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>4035213093</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute ( Site 0159)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Center ( Site 0151)</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>9053879495</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Cancer Centre ( Site 0154)</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>613737770070185</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>5142523400 x5766</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre ( Site 0162)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>514-934-1934</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>James Lind Centro de Investigación del Cáncer ( Site 1653)</name>
      <address>
        <city>Temuco</city>
        <state>Araucania</state>
        <zip>4800827</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+56994443272</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bradfordhill ( Site 1651)</name>
      <address>
        <city>Santiago</city>
        <state>Region M. De Santiago</state>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+56998744662</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Oncológica del Norte ( Site 1652)</name>
      <address>
        <city>Antofagasta</city>
        <zip>1240000</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+56994198125</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oncomedica S.A. ( Site 0205)</name>
      <address>
        <city>Monteria</city>
        <state>Cordoba</state>
        <zip>230002</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)</name>
      <address>
        <city>Bogota</city>
        <state>Distrito Capital De Bogota</state>
        <zip>111411</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+573002037459</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerologia E.S.E ( Site 0204)</name>
      <address>
        <city>Bogota</city>
        <state>Distrito Capital De Bogota</state>
        <zip>111511</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+573108658288</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oncologos del Occidente S.A. ( Site 0206)</name>
      <address>
        <city>Pereira</city>
        <state>Risaralda</state>
        <zip>660001</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+573114746650</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundación Cardiovascular de Colombia ( Site 0207)</name>
      <address>
        <city>Piedecuesta</city>
        <state>Santander</state>
        <zip>68017</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Fundacion Valle del Lili ( Site 0202)</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760032</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+573148883972</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital ARCHET 2 ( Site 0356)</name>
      <address>
        <city>Nice</city>
        <state>Alpes-Maritimes</state>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33492036223</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Joseph ( Site 0376)</name>
      <address>
        <city>Marseille</city>
        <state>Bouches-du-Rhone</state>
        <zip>13285</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33491806625</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital La Timone ( Site 0353)</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>+33491387991</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)</name>
      <address>
        <city>Caen</city>
        <state>Calvados</state>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33231272506</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Besancon - Hopital Jean Minjoz ( Site 0359)</name>
      <address>
        <city>Besancon</city>
        <state>Doubs</state>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33381218102</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Valence ( Site 0377)</name>
      <address>
        <city>Valence</city>
        <state>Drome</state>
        <zip>26953</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33475757549</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>C.H.U. de Nimes. Hopital Caremeau ( Site 0368)</name>
      <address>
        <city>Nimes</city>
        <state>Gard</state>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33466684043</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux- Hopital Saint Andre ( Site 0370)</name>
      <address>
        <city>Bordeaux</city>
        <state>Gironde</state>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33557822521</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud IUCT Oncopole ( Site 0354)</name>
      <address>
        <city>Toulouse</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33567778134</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Annecy Genevois ( Site 0361)</name>
      <address>
        <city>Pringy</city>
        <state>Haute-Savoie</state>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33450636863</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier. ( Site 0367)</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33467336933</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille - Hopital Claude Huriez ( Site 0355)</name>
      <address>
        <city>Lille</city>
        <state>Nord</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33320444193</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Estaing ( Site 0360)</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Puy-de-Dome</state>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33473755226</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Lyon Sud Hospices Civils de Lyon ( Site 0350)</name>
      <address>
        <city>Pierre Benite</city>
        <state>Rhone</state>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33478861679</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Avicenne ( Site 0358)</name>
      <address>
        <city>Bobigny</city>
        <state>Seine-Saint-Denis</state>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+33148957090</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy ( Site 0352)</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>+33142114210</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers ( Site 0375)</name>
      <address>
        <city>Poitiers</city>
        <state>Vienne</state>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Tuebingen ( Site 0409)</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>+4970712985748</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Nord ( Site 0415)</name>
      <address>
        <city>Nürnberg</city>
        <state>Bayern</state>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+49 911 398 2044</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)</name>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4964215862321</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)</name>
      <address>
        <city>Buxtehude</city>
        <state>Niedersachsen</state>
        <zip>21614</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4941617036250</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover ( Site 0405)</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen ( Site 0403)</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+492017232431</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4930450518705</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>004915222873742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Andreas Syggros Hospital ( Site 0450)</name>
      <address>
        <city>Athens</city>
        <state>Achaia</state>
        <zip>161 21</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+302107265212</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Attikon University General Hospital of Athens ( Site 0454)</name>
      <address>
        <city>Chaidari</city>
        <state>Attiki</state>
        <zip>124 62</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+306944888568</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Metropolitan Hospital ( Site 0453)</name>
      <address>
        <city>Neo Faliro</city>
        <state>Attiki</state>
        <zip>185 47</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Papageorgiou General Hospital ( Site 0451)</name>
      <address>
        <city>Thessaloniki</city>
        <zip>564 03</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>European Interbalkan Medical Center ( Site 0455)</name>
      <address>
        <city>Thessaloniki</city>
        <zip>570 01</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+306942608228</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pecsi Tudomanyegyetem AOK ( Site 0501)</name>
      <address>
        <city>Pecs</city>
        <state>Baranya</state>
        <zip>7632</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+36202520267</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem ( Site 0504)</name>
      <address>
        <city>Szeged</city>
        <state>Csongrad</state>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3662545545</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)</name>
      <address>
        <city>Nyiregyhaza</city>
        <state>Szabolcs-Szatmar-Bereg</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem. ( Site 0506)</name>
      <address>
        <city>Debrecen</city>
        <state>Vas</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem ( Site 0507)</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+36206663413</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Szent Imre Egyetemi Oktatokorhaz ( Site 0502)</name>
      <address>
        <city>Budapest</city>
        <zip>1115</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+36209434922</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. James s Hospital ( Site 1601)</name>
      <address>
        <city>Dublin 8</city>
        <state>Dublin</state>
        <zip>D08 K0Y5</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3514162164</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center ( Site 0555)</name>
      <address>
        <city>Beer Sheva</city>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>97286400295</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus-Oncology Division ( Site 0552)</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+9724854311</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haddassah Medical Organization - Ein Kerem ( Site 0553)</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>972508946244</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center ( Site 0556)</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428132</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center ( Site 0550)</name>
      <address>
        <city>Petah Tiqwa</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+97239378004</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center ( Site 0551)</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center ( Site 0554)</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instituto Tumori Giovanni Paolo II ( Site 0604)</name>
      <address>
        <city>Bari</city>
        <state>Puglia</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+390805555363</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana ( Site 0603)</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+39050992466</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+390223902150</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia ( Site 0602)</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+3902574891094</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+390815903752</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)</name>
      <address>
        <city>Tuxtla Gutierrez</city>
        <state>Chiapas</state>
        <zip>29090</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>5215543785105</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cimab SA de CV ( Site 0708)</name>
      <address>
        <city>Torreon</city>
        <state>Coahuila</state>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Clínica de Alta Especialidad ( Site 0715)</name>
      <address>
        <city>Torreón</city>
        <state>Coahuila</state>
        <zip>27010</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Onco-Hematologia de Occidente ( Site 0716)</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44260</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>3315145351</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Especialidades Centro Medico de Occidente ( Site 0704)</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44349</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Consultorios de Medicina Especializada del Sector Privado ( Site 0701)</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44680</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centro de atencion e investigacion clinica en oncologia ( Site 0706)</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97134</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centro Estatal de Cancerologia de Chihuahua ( Site 0703)</name>
      <address>
        <city>Chihuahua</city>
        <zip>31000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+526144106742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>FAICIC Clinical Research ( Site 0700)</name>
      <address>
        <city>Veracruz</city>
        <zip>91900</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+522299327808</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>New Zealand Clinical Research (Auckland) ( Site 0800)</name>
      <address>
        <city>Auckland</city>
        <zip>0624</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+6493733474</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haukeland sykehus ( Site 0851)</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4755974200</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital HF ( Site 0852)</name>
      <address>
        <city>Trondheim</city>
        <state>Sor-Trondelag</state>
        <zip>7030</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus Radiumhospitalet ( Site 0850)</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4722934000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-115</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+48607941715</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)</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>+48226439375</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site</name>
      <address>
        <city>Gdańsk</city>
        <state>Pomorskie</state>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>48583493190</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)</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>48784981888</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Particular do Algarve ( Site 1005)</name>
      <address>
        <city>Faro</city>
        <zip>8005-226</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia de Lisboa ( Site 1003)</name>
      <address>
        <city>Lisboa</city>
        <zip>1099-023</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 - Tejo ( Site 1004)</name>
      <address>
        <city>Lisboa</city>
        <zip>1350-352</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CHLN Hospital Santa Maria ( Site 1001)</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)</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>S C Pelican Impex SRL ( Site 1108)</name>
      <address>
        <city>Oradea</city>
        <state>Bihor</state>
        <zip>410469</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hifu Terramed Conformal SRL ( Site 1111)</name>
      <address>
        <city>Bucharest</city>
        <state>Bucuresti</state>
        <zip>031864</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cardiomed SRL Cluj-Napoca ( Site 1104)</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40724543672</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4026459831</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spitalul Universitar CF Cluj-Napoca ( Site 1103)</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40724283983</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)</name>
      <address>
        <city>Craiova</city>
        <state>Dolj</state>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40727774974</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>S C Oncocenter Oncologie Medicala S R L ( Site 1106)</name>
      <address>
        <city>Timisoara</city>
        <state>Timis</state>
        <zip>300166</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40356464000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinica Oncomed SRL ( Site 1105)</name>
      <address>
        <city>Timisoara</city>
        <state>Timis</state>
        <zip>300239</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40745100495</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>S.C.Focus Lab Plus S.R.L ( Site 1107)</name>
      <address>
        <city>Bucuresti</city>
        <zip>022548</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+40721298677</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)</name>
      <address>
        <city>Bucuresti</city>
        <zip>030447</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Altay Regional Oncology Dispensary ( Site 1168)</name>
      <address>
        <city>WBarnaularsaw</city>
        <state>Altayskiy Kray</state>
        <zip>656045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)</name>
      <address>
        <city>Ufa</city>
        <state>Baskortostan, Respublika</state>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological</name>
      <address>
        <city>Obninsk</city>
        <state>Kaluzskaja Oblast</state>
        <zip>249036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)</name>
      <address>
        <city>Sochi</city>
        <state>Krasnodarskiy Kray</state>
        <zip>354057</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical-Oncology department ( Site 1173)</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaya Oblast</state>
        <zip>121205</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>N.N. Blokhin NMRCO ( Site 1153)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>FSCC FMBA of Russia ( Site 1163)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>115682</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)</name>
      <address>
        <city>Nizhny Novgorod</city>
        <state>Nizhegorodskaya Oblast</state>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Railway Hospital of OJSC ( Site 1161)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)</name>
      <address>
        <city>Izhevsk</city>
        <state>Udmurtskaya Respublika</state>
        <zip>426009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)</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 Duran i Reynals ( Site 1254)</name>
      <address>
        <city>Hospitalet del Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla ( Site 1256)</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial Barcelona ( Site 1253)</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34932275402</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)</name>
      <address>
        <city>Doniostia - San Sebastian</city>
        <state>Gipuzkoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34943328315</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitari Vall d Hebron ( Site 1252)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+349327460004350</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal ( Site 1251)</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34913368263</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Carlos Haya ( Site 1255)</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+34951291165</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprise &quot;Prykarpatski Clinical On-Department for daily treated patient (</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <state>Ivano-Frankivska Oblast</state>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivska Oblast</state>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)</name>
      <address>
        <city>Kropyvnytskyi</city>
        <state>Kirovohradska Oblast</state>
        <zip>25011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)</name>
      <address>
        <city>Sumy</city>
        <state>Sumska Oblast</state>
        <zip>40022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Universal Clinic Oberig-Oncology Center ( Site 1461)</name>
      <address>
        <city>Kyiv</city>
        <zip>03057</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospitals NHS Trust ( Site 1402)</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+441872258310</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University College Hospital London ( Site 1400)</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+4402034475085</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guy s &amp; St Thomas NHS Foundation Trust ( Site 1407)</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>+4402071887188</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)</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>+442078082132</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Marsden NHS Foundation Trust ( Site 1408)</name>
      <address>
        <city>Sutton</city>
        <state>London, City Of</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>0207 352 8171</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital ( Site 1404)</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.merckclinicaltrials.com/</url>
    <description>Merck Clinical Trial Information</description>
  </link>
  <link>
    <url>https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-630&amp;kw=3475-630</url>
    <description>Plain Language Summary</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</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>Programmed Cell Death-1 (PD-1)</keyword>
  <keyword>Programmed Cell Death 1</keyword>
  <keyword>PD1</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</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03833167
org study id: 3475-630
secondary id: MK-3475-630
secondary id: KEYNOTE-630
secondary id: 2018-001974-76
nct id: NCT03833167
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo
      given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous
      cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with
      radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in
      increasing recurrence free survival (RFS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
time frame: Up to approximately 60 months
description: RFS was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first.
measure: Overall Survival (OS)
time frame: Up to approximately 60 months
description: OS is the time from randomization to death due to any cause.
measure: Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
time frame: Baseline and up to approximately 60 months
description: Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.
measure: Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score
time frame: Baseline and up to approximately 60 months
description: Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.
measure: Percentage of Participants Who Experience an Adverse Event (AE)
time frame: Up to approximately 63 months
description: An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE will be presented.
measure: Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
time frame: Up to approximately 38 months
description: An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE will be presented.
arm group label: Pembrolizumab
arm group type: Experimental
description: Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
intervention type: Biological
intervention name: Pembrolizumab 400 mg
description: Administered by IV infusion on Day 1 of each 42-day cycle
arm group label: Pembrolizumab
other name: KEYTRUDA®
other name: MK-3475
intervention type: Drug
intervention name: Placebo
description: Administered by IV infusion on Day 1 of each 42-day cycle
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
last name: Toll Free Number
phone: 1-888-577-8839
email: Trialsites@merck.com
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country: Argentina
country: Australia
country: Brazil
country: Canada
country: Chile
country: Colombia
country: France
country: Germany
country: Greece
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Mexico
country: New Zealand
country: Norway
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: United States
url: https://www.merckclinicaltrials.com/
description: Merck Clinical Trial Information
url: https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-630&kw=3475-630
description: Plain Language Summary
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php