<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/NCT04459715</url>
  </required_header>
  <id_info>
    <org_study_id>MS202359_0006</org_study_id>
    <secondary_id>2020-000377-25</secondary_id>
    <secondary_id>Debio 1143-SCCHN-301</secondary_id>
    <nct_id>NCT04459715</nct_id>
  </id_info>
  <brief_title>A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)</brief_title>
  <official_title>A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMD Serono Research &amp; Development Institute, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GORTEC (Head and Neck Oncology and Radiotherapy Group)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck KGaA, Darmstadt, Germany</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>EMD Serono</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio&#xD;
      1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell&#xD;
      carcinoma of the head and neck (LA-SCCHN).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-Free Survival (EFS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>EFS is the time from the date of randomization to the date of first record of disease progression or death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>OS is the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional Control (LRC)</measure>
    <time_frame>From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate (CRR)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Radical Salvage Surgery</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Subsequent Systemic Cancer Treatments</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure</measure>
    <time_frame>From signed informed consent to EOS (within 6.8 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom</measure>
    <time_frame>Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)</time_frame>
    <description>Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline in Swallowing and Pain Symptoms</measure>
    <time_frame>Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)</time_frame>
    <description>Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&amp;N35)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">730</enrollment>
  <condition>Squamous Cell Carcinoma of the Head and Neck</condition>
  <arm_group>
    <arm_group_label>Xevinapant (Debio 1143)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive:&#xD;
Concomitant chemo-radiation therapy period (Cycles 1-3):&#xD;
Radiotherapy&#xD;
Cisplatin&#xD;
Xevinapant (Debio 1143)&#xD;
Monotherapy period (Cycles 4-6):&#xD;
• Xevinapant (Debio 1143)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive:&#xD;
Concomitant chemo-radiation therapy period (Cycles 1-3):&#xD;
Radiotherapy&#xD;
Cisplatin&#xD;
Matched placebo&#xD;
Monotherapy period (Cycles 4-6):&#xD;
• Matched placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xevinapant (Debio 1143)</intervention_name>
    <description>Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.</description>
    <arm_group_label>Xevinapant (Debio 1143)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin administered as an IV infusion every 3 weeks (Q3W).</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Xevinapant (Debio 1143)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity Modulation Radiation Therapy (IMRT)</intervention_name>
    <description>70 Gy given in 35 fractions over 7 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Xevinapant (Debio 1143)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1&#xD;
&#xD;
          -  Histologically confirmed diagnosis of previously untreated Locally Advanced Squamous&#xD;
             Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb&#xD;
             according to the American Joint Committee on Cancer(AJCC))/Classification of malignant&#xD;
             tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant&#xD;
             metastasis (TNM) Staging System, 8th Edition.) suitable for definitive&#xD;
             ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx,&#xD;
             hypopharynx and larynx&#xD;
&#xD;
          -  For OroPharyngeal Cancer (OPC) participants, primary tumors must be human&#xD;
             papillomavirus (HPV)-negative as determined by p16 expression using&#xD;
             immunohistochemistry&#xD;
&#xD;
          -  Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by&#xD;
             computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on&#xD;
             Response evaluation criteria in solid tumors (RECIST) version 1.1&#xD;
&#xD;
          -  Peripheral neuropathy less than (&lt;) grade 2&#xD;
&#xD;
          -  Adequate hematologic, renal and hepatic function&#xD;
&#xD;
          -  Other protocol defined inclusion criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary,&#xD;
             thyroid or parathyroid gland pathologies, skin or unknown primary site&#xD;
&#xD;
          -  Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)&#xD;
&#xD;
          -  Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and&#xD;
             neck region which may jeopardize the primary tumor irradiation plan, or any other&#xD;
             prior SCCHN systemic treatment, including investigational agents&#xD;
&#xD;
          -  Documented weight loss of &gt;10% during the last 4 weeks prior to randomization (unless&#xD;
             adequate measures are undertaken for nutritional support), OR plasmatic albumin &lt; 3.0&#xD;
             g/dL. No albumin transfusions are allowed within 2 weeks before randomization&#xD;
&#xD;
          -  Known allergy to Xevinapant (Debio 1143), cisplatin, carboplatin, other platinum-based&#xD;
             agent or any excipient known to be present in any of these products or in the placebo&#xD;
             formulation&#xD;
&#xD;
          -  other protocol defined exclusion criteria may apply&#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 Responsible</last_name>
    <role>Study Director</role>
    <affiliation>Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regents of the University of California</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope &amp; Innovation</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado at Denver and Health Sciences Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale Cancer Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lombardi Comprehensive Cancer Center, Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASCLEPES Research Centers</name>
      <address>
        <city>Weeki Wachee</city>
        <state>Florida</state>
        <zip>34607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IACT Health, John B. Amos Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashland-Bellefonte Cancer Center</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114-2696</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University South Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-9001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri - Ellis Fischel Cancer Center</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Cancer Care</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Nevada (Southern Hills) (USA)</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Hospital-Long Island Oncology</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center at NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Grossman School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center- Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gettysburg Cancer Center</name>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <zip>17325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina- Hollings Cancer Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHO Corporation/Utah Cancer Specialists</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Aleman</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Medico Especialazado Alexander Fleming</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria Reina Fabiola</name>
      <address>
        <city>Cordoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncologia de Rosario</name>
      <address>
        <city>Santa Fe</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Viedma</name>
      <address>
        <city>Viedma</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford Cancer Centre Research, Tennyson Centre</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital</name>
      <address>
        <city>Darlinghurst</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wollongong Hospital</name>
      <address>
        <city>Wollongong</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital, Cancer Trials Unit</name>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Salzburg</name>
      <address>
        <city>Salzburg</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Innere Medizin III der PMU</name>
      <address>
        <city>Salzburg</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna, Department of Medicine I, Division of Oncology</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hopital de Charleroi</name>
      <address>
        <city>Charleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Jolimont, Rue Ferrer</name>
      <address>
        <city>La Louvière</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven, Radiotherapy &amp; Oncology</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Ardenne (CHA)</name>
      <address>
        <city>Libramont</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur Site Sainte Elisabeth</name>
      <address>
        <city>Namur</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.Z. Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GZA Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela</name>
      <address>
        <city>Barretos</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Caridade de Ijui, Avenida David Jose Martins</name>
      <address>
        <city>Ijuí</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro</name>
      <address>
        <city>Natal</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Gaúcho Integrado, Rua Costa</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Rio De Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC</name>
      <address>
        <city>Santo André</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima</name>
      <address>
        <city>São José Do Rio Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo (ICESP)</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oswaldo Cruz German Hospital</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Program, London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Montréal</name>
      <address>
        <city>Montreal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec-Université Laval</name>
      <address>
        <city>Québec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 5th Affiliated Hospital of Sun yet-sen university</name>
      <address>
        <city>Guangdong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 2nd Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Province Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Tumor Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lin Yi Cancer Hospital</name>
      <address>
        <city>Shandong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shantou University Cancer Hospital</name>
      <address>
        <city>Shantou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; institute</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital/Tongji Medical College, Huazhong University of Science</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital hradec Kralové</name>
      <address>
        <city>Hradec Králové</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Ostrava</name>
      <address>
        <city>Ostrava-Poruba</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Na Bulovce</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KOC KNTB a.s. Zlín</name>
      <address>
        <city>Zlín</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens Picardie - Hopital Sud</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l Ouest (ICO)</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Sainte Catherine</name>
      <address>
        <city>Avignon Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Universitaire de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest Hopital Morvan</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin CLCC</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Guillaume Le Conquerant</name>
      <address>
        <city>le Havre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Victor Hugo</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Libourne</name>
      <address>
        <city>Libourne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital du Scorff</name>
      <address>
        <city>Lorient</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'Oncologie Médicale, CHU Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Franche Comté</name>
      <address>
        <city>Montbeliard</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Regional du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHopital prive du Confluent Nantes</name>
      <address>
        <city>Nantes Cedex 2</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCConcorde (GCS)</name>
      <address>
        <city>Neuilly sur Seine</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nimes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugène Marquis</name>
      <address>
        <city>Rennes Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel CLCC</name>
      <address>
        <city>Rouen Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHP Saint Gregoire FINESS</name>
      <address>
        <city>Saint Gregoire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest - Site Saint Herblain</name>
      <address>
        <city>Saint Herblain</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICANS</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud - IUCT-O</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Public Hospital L'Institut de Cancerologie de Lorraine</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy - Service de radiotherapie</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evex Hospitals Oncology Center</name>
      <address>
        <city>Kutaisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Research Cent 4</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Clinical Oncology</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JSC &quot;Evex Hospitals&quot;</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LEPL First University Clinic of Tbilisi State Medical University</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hospitals</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin Campus Virchow</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strahlenklinik des Uni-Klinikums</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of radiation oncology, University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Schleswig-Holstein, Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin Rostock</name>
      <address>
        <city>Rostock</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agioi Anargiroi General Oncology Hospital of Kifissia</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Attikon University Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theagenio Anticancer Hospital</name>
      <address>
        <city>Thessaloníki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Onkologiai Intezet Sugarterapias Osztaly</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uzsoki Utcai Korhaz Onkologiai Osztaly</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aladár Megyei Kórház Onkoradiológiai Osztály</name>
      <address>
        <city>Győr</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Healthcare Campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Fund of the Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tiqva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico</name>
      <address>
        <city>Aviano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto di Candiolo IRCCS</name>
      <address>
        <city>Candiolo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle</name>
      <address>
        <city>Cuneo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS AOU San Martino</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;Vito Fazzi&quot; Lecce</name>
      <address>
        <city>Lecce</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. USL 6 Ospedali Riuniti-Ospedale di Livorno</name>
      <address>
        <city>Livorno</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)</name>
      <address>
        <city>Meldola</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AORN Ospedale dei Monaldi</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori (INT) IRCCS Fondazione &quot;G. Pascale&quot;</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto Irccs</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL2_Presidio Ospedaliero San Paolo</name>
      <address>
        <city>Savona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kamigyo-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Kita-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Kita-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Nagaizumi-cho</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hematologic Oncology</name>
      <address>
        <city>Goyang-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center, Asian Cacer Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KonKuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital, Oncol &amp; Hematology</name>
      <address>
        <city>Yangsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpitale Pomorskie Sp. z o.o.</name>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach</name>
      <address>
        <city>Gliwice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SP ZOZ MSWiA z W-M CO w Olsztynie</name>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Provita Prolife Centrum Medyczne</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Clinico Academico</name>
      <address>
        <city>Braga</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Braga</name>
      <address>
        <city>Braga</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE</name>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)</name>
      <address>
        <city>Faro</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário Lisboa Norte</name>
      <address>
        <city>Lissabon</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Vila Nova de Gaia/Espinho</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitario São João</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pedro Hispano</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Autonomous Healthcare Institution &quot;Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan&quot;</name>
      <address>
        <city>Kazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky</name>
      <address>
        <city>Krasnoyarsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kursk Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Kursk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FGBU N.N.Blokhin Russian Cancer Research Center</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EuroCityClinic</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI National Med Research Cancer Center N.N. Petrov</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncological Dispensary of Bashkortostan</name>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)</name>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Centro Oncologico de Galicia (COG) &quot;Jose Antonio Quiroga y Pineyro&quot;</name>
      <address>
        <city>A Coruña</city>
        <state>Galicia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro</name>
      <address>
        <city>A Coruna</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncologia Badalona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncologia, Hospital Duran</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitari Dexeus-Quiron (ESP)</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Reina Sofía</name>
      <address>
        <city>Cordoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncologia</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Insular de Gran Canaria</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Althaia, Xarxa Assistencial</name>
      <address>
        <city>Manresa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacio Althaia</name>
      <address>
        <city>Manresa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civil (Hospital Regional Universitario)</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla. Santander</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVO</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Geneve</name>
      <address>
        <city>Geneve</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang-Gung Memorial Hospital-Kaohsiung</name>
      <address>
        <city>Kaohsiung City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital (VGHTP)</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center ASKLEPION LLC</name>
      <address>
        <city>Khodosivka</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kiev City Clinical Oncology Centre</name>
      <address>
        <city>Kiev</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center of Yuriy Spizhenko, Soborna Vulytsia</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal infirmary, Dept. of Oncology</name>
      <address>
        <city>Aberdeen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Chelsea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre</name>
      <address>
        <city>Northwood</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust - Sutton</name>
      <address>
        <city>Sutton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clatterbridge Cancer Centre NHS Foundation Trust</name>
      <address>
        <city>Wirral</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.emdgroup.com/en/</url>
    <description>Trial Awareness and Transparency website</description>
  </link>
  <link>
    <url>https://medical.emdserono.com/en_US/home.html</url>
    <description>US Medical Information website, Medical Resources</description>
  </link>
  <link>
    <url>https://trilynxclinicaltrial.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TrilynX</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union</ipd_time_frame>
    <ipd_access_criteria>Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union</ipd_access_criteria>
    <ipd_url>http://bit.ly/IPD21</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/NCT04459715
org study id: MS202359_0006
secondary id: 2020-000377-25
secondary id: Debio 1143-SCCHN-301
nct id: NCT04459715
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio
      1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell
      carcinoma of the head and neck (LA-SCCHN).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Event-Free Survival (EFS)
time frame: Up to 5 years
description: EFS is the time from the date of randomization to the date of first record of disease progression or death.
measure: Overall survival (OS)
time frame: Up to 5 years
description: OS is the time from randomization to death due to any cause.
measure: Progression-Free Survival (PFS)
time frame: Up to 5 years
description: PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)
measure: Locoregional Control (LRC)
time frame: From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years)
measure: Objective Response Rate (ORR)
time frame: Up to 5 years
description: ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).
measure: Complete Response Rate (CRR)
time frame: Up to 5 years
description: CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).
measure: Duration of Response (DOR)
time frame: Up to 5 years
description: Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.
measure: Number of Participants with Radical Salvage Surgery
time frame: Up to 5 years
measure: Time to Subsequent Systemic Cancer Treatments
time frame: Up to 5 years
measure: Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure
time frame: From signed informed consent to EOS (within 6.8 years)
measure: Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
time frame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
description: Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)
measure: Changes from Baseline in Swallowing and Pain Symptoms
time frame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
description: Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)
arm group label: Xevinapant (Debio 1143)
arm group type: Experimental
description: Participants will receive:
Concomitant chemo-radiation therapy period (Cycles 1-3):
Radiotherapy
Cisplatin
Xevinapant (Debio 1143)
Monotherapy period (Cycles 4-6):
• Xevinapant (Debio 1143)
arm group label: Placebo
arm group type: Active Comparator
description: Participants will receive:
Concomitant chemo-radiation therapy period (Cycles 1-3):
Radiotherapy
Cisplatin
Matched placebo
Monotherapy period (Cycles 4-6):
• Matched placebo
intervention type: Drug
intervention name: Xevinapant (Debio 1143)
description: Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.
arm group label: Xevinapant (Debio 1143)
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin administered as an IV infusion every 3 weeks (Q3W).
arm group label: Placebo
arm group label: Xevinapant (Debio 1143)
intervention type: Radiation
intervention name: Intensity Modulation Radiation Therapy (IMRT)
description: 70 Gy given in 35 fractions over 7 weeks.
arm group label: Placebo
arm group label: Xevinapant (Debio 1143)
intervention type: Drug
intervention name: Placebo
description: Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Responsible
role: Study Director
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: China
country: Czechia
country: France
country: Georgia
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Portugal
country: Russian Federation
country: Spain
country: Switzerland
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
url: https://clinicaltrials.emdgroup.com/en/
description: Trial Awareness and Transparency website
url: https://medical.emdserono.com/en_US/home.html
description: US Medical Information website, Medical Resources
url: https://trilynxclinicaltrial.com/
description: Related Info
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Cisplatin
sharing ipd: Yes
ipd description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
ipd access criteria: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
ipd url: http://bit.ly/IPD21