<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/NCT04410445</url>
  </required_header>
  <id_info>
    <org_study_id>20-214-29/CA045-022</org_study_id>
    <nct_id>NCT04410445</nct_id>
  </id_info>
  <brief_title>Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence</brief_title>
  <acronym>PIVOT-12</acronym>
  <official_title>A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nektar Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nektar Therapeutics</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>
      The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab&#xD;
      versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous&#xD;
      melanoma who are at high risk for recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this study is to compare the efficacy, as measured by recurrence-free&#xD;
      survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus&#xD;
      nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN]&#xD;
      metastasis &gt; 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC]&#xD;
      8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for&#xD;
      recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    (Sponsor decision)&#xD;
  </why_stopped>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">September 22, 2022</completion_date>
  <primary_completion_date type="Actual">September 22, 2022</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>
    <intervention_model_description>Patients will be randomized in a 1:1 ratio to one of two treatment arms</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Approximately up to 21 months</time_frame>
    <description>To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire</measure>
    <time_frame>From baseline, up to approximately 6 months</time_frame>
    <description>The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.</measure>
    <time_frame>Up to 21 months</time_frame>
    <description>Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">765</enrollment>
  <condition>Melanoma</condition>
  <condition>Melanoma Stage III</condition>
  <condition>Melanoma Stage IV</condition>
  <condition>Melanoma (Skin)</condition>
  <arm_group>
    <arm_group_label>Combination of bempegaldesleukin (NKTR-214) + nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nivolumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm B: Participants will receive nivolumab IV alone every 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bempegaldesleukin</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Combination of bempegaldesleukin (NKTR-214) + nivolumab</arm_group_label>
    <other_name>NKTR-214</other_name>
    <other_name>BMS-986321</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Combination of bempegaldesleukin (NKTR-214) + nivolumab</arm_group_label>
    <arm_group_label>Nivolumab</arm_group_label>
    <other_name>Opdivo®</other_name>
    <other_name>BMS-936558</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, age 12 years or older at the time of signing the informed&#xD;
             consent form (age 18 years or older where local regulations, countries, and/or&#xD;
             institutional policies do not allow for patients &lt; 18 years of age (adolescents) to&#xD;
             participate). In regions where adolescents are not allowed to participate in the study&#xD;
             due to age restrictions, enrolled patients must be ≥ 18 years of age.&#xD;
&#xD;
          -  Histologically confirmed Stage IIIA (LN metastasis &gt; 1 mm), IIIB/C/D, or IV&#xD;
             (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been&#xD;
             completely surgically resected within 12 weeks prior to randomization.&#xD;
&#xD;
          -  Tumor tissue available from biopsy or resected disease must be provided to central&#xD;
             laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for&#xD;
             stratification purposes.&#xD;
&#xD;
          -  Disease-free status documented by a complete physical examination and imaging studies&#xD;
             within 28 days prior to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ocular/uveal melanoma or mucosal melanoma.&#xD;
&#xD;
          -  Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus,&#xD;
             hypothyroidism only requiring hormone replacement, skin disorders not requiring&#xD;
             systemic treatment, or conditions not expected to recur in the absence of an external&#xD;
             trigger are permitted to enroll.&#xD;
&#xD;
          -  Conditions requiring systemic treatment with either corticosteroids (&gt; 10 mg daily&#xD;
             prednisone equivalent) or other immunosuppressive medications within 14 days of&#xD;
             randomization. Inhaled or topical steroids, and adrenal replacement steroid doses &gt; 10&#xD;
             mg daily prednisone equivalent, are permitted in the absence of active autoimmune&#xD;
             disease.&#xD;
&#xD;
          -  Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant&#xD;
             radiation therapy for central nervous system lesions.&#xD;
&#xD;
          -  Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2&#xD;
             (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or&#xD;
             anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any&#xD;
             other antibody or drug specifically targeting T cell co-stimulation or checkpoint&#xD;
             pathways).&#xD;
&#xD;
          -  Prior malignancy active within the previous 3 years except for locally potentially&#xD;
             curable cancers that have been apparently cured.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Nektar Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Honor Health</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Hospital, Inpatient Pharmacy</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Fontana</city>
        <state>California</state>
        <zip>92335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Medical Group of Orange County, Inc.</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emad Ibrahim, MD, Inc</name>
      <address>
        <city>Redlands</city>
        <state>California</state>
        <zip>92373</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Oncology Associates</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Cancer Associates for Research and Excellence</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angeles Clinic and Research Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers (Littleton) - USOR</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado - Cancer Center - PPDS</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health Cancer Institute</name>
      <address>
        <city>Longwood</city>
        <state>Florida</state>
        <zip>32750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goshen Center For Cancer Care</name>
      <address>
        <city>Goshen</city>
        <state>Indiana</state>
        <zip>46526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - PIN</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</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>Frontier Cancer Center and Blood Institute</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center - PIN</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>32750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Cancer Institute, Franz Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Physician Group (LVPG) - Hematology Oncology</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI Tennessee Oncology Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI Tennessee Oncology Nashville</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Pharmacy Investigational Drug Services</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology (Loop) - USOR</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists (Salt Lake City)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Cancer Care - USOR</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cairns Hospital</name>
      <address>
        <city>Cairns</city>
        <zip>4870</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icon Cancer Care Wesley</name>
      <address>
        <city>Chermside</city>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gallipoli Medical Research Foundation</name>
      <address>
        <city>Greenslopes</city>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affinity Clinical Research</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melanoma Institute Australia</name>
      <address>
        <city>North Sydney</city>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Southport</city>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tasman Oncology Research</name>
      <address>
        <city>Southport</city>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blacktown Hospital</name>
      <address>
        <city>Westmead</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH</name>
      <address>
        <city>Lienz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Feldkirch</name>
      <address>
        <city>Rankweil</city>
        <zip>6830</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salzburger Landeskliniken</name>
      <address>
        <city>Salzburg</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum St. Pölten</name>
      <address>
        <city>St.Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus der Stadt Wien</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mou/Mmci - Ppds</name>
      <address>
        <city>Brno</city>
        <zip>65653</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Králové</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krajska nemocnice Liberec, a.s.</name>
      <address>
        <city>Liberec</city>
        <zip>46063</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>79900</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava Poruba</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Na Bulovce</name>
      <address>
        <city>Prague</city>
        <zip>16000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna Fakultni Nemocnice V Praze</name>
      <address>
        <city>Praha</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-André</name>
      <address>
        <city>Bordeau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Tours</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Albert Michallon La Tronche</name>
      <address>
        <city>La Tronche</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôtel Dieu - Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>6202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75877</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Saint Etienne</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94801</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhr Universität Bochum</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elben Klinken Stade - Buxtehude</name>
      <address>
        <city>Buxtehude</city>
        <zip>21614</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus an der TU Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>81307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Erfurt</name>
      <address>
        <city>Erfurt</city>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRH Wald-Klinikum Gera GmbH</name>
      <address>
        <city>Gera</city>
        <zip>7548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Halle (Saale)</name>
      <address>
        <city>Halle</city>
        <zip>6097</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SLK Kliniken Heilbronn GmbH</name>
      <address>
        <city>Heilbronn</city>
        <zip>74078</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Ludwigshafen gGmbH</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>39014</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Mannheim Universitätsklinikum gGmbH</name>
      <address>
        <city>Mannheim</city>
        <zip>76297</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Munster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fachklinik Hornheide</name>
      <address>
        <city>Münster</city>
        <zip>48157</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Schwerin</name>
      <address>
        <city>Schwerin</city>
        <zip>19049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>76297</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laiko General Hospital of Athens</name>
      <address>
        <city>Ampelokipoi</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Dunant Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Hospital - First Oncology Clinic</name>
      <address>
        <city>Athens</city>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Hospital - Fourth Oncology Clinic</name>
      <address>
        <city>Athens</city>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pepagni Hospital</name>
      <address>
        <city>Heraklion</city>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of Athens</name>
      <address>
        <city>Maroúsi</city>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interbalkan Medical Center of Thessaloniki</name>
      <address>
        <city>Pylaía</city>
        <zip>TK57001</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theageneio Anticancer Oncology Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloníki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papageorgiou General Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloníki</city>
        <zip>56429</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinic Thessaloniki (Galinos clinic)</name>
      <address>
        <city>Thessaloníki</city>
        <zip>86</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HaEmek Medical Center</name>
      <address>
        <city>Afula</city>
        <zip>18101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Centre</name>
      <address>
        <city>Be'er Sheva</city>
        <zip>8410501</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center - PPDS</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center - PPDS</name>
      <address>
        <city>Jerusalem</city>
        <zip>9574425</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center - PPDS</name>
      <address>
        <city>Petah tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center - PPDS</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Giovanni Paolo II Istituto Oncologico</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione del Piemonte per l'Oncologia (IRCCS)</name>
      <address>
        <city>Candiolo</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Policlinico San Martino</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo Di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Dei Tumori</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Di Modena Policlinico</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto - I.R.C.C.S.</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medisch Centrum</name>
      <address>
        <city>Heerlen</city>
        <zip>6419</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maxima Medisch Centrum</name>
      <address>
        <city>Veldhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <zip>8025AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8140</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <zip>9054</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tauranga Hospital</name>
      <address>
        <city>Tauranga</city>
        <zip>3143</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku</name>
      <address>
        <city>Białystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdańsk</city>
        <zip>80952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska</name>
      <address>
        <city>Lublin</city>
        <zip>20064</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu</name>
      <address>
        <city>Poznań</city>
        <zip>60780</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar E Universitário de Coimbra EPE</name>
      <address>
        <city>Coimbra</city>
        <zip>3004-561</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Tejo</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.</name>
      <address>
        <city>Lisbon</city>
        <zip>1099-023</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Romania SRL</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Medisprof SRL</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400641</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Onco Clinic Consult SA</name>
      <address>
        <city>Craiova</city>
        <zip>200094</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Center Sfantul Nectarie</name>
      <address>
        <city>Craiova</city>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelyabinsk Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Centre #1</name>
      <address>
        <city>Krasnodar</city>
        <zip>350040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660133</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kursk Regional Oncology Centre</name>
      <address>
        <city>Kursk</city>
        <zip>305524</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMI Euromedservice</name>
      <address>
        <city>Pushkin</city>
        <zip>196603</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Ryazan'</city>
        <zip>390011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Railway Clinical Hospital JSC RZhD</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Oncology Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08911</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de La Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Dexeus - Grupo Quironsalud</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron - PPDS</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO l'Hospitalet - Hospital Duran i Reynals</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de La Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Jaen</name>
      <address>
        <city>Jaén</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. Regional Reina Sofia - PPDS</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <zip>08904</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro - CIOCC</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>4628007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29789</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB20QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital</name>
      <address>
        <city>Cottingham</city>
        <zip>HU165JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <zip>LE15WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <zip>BG72UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <zip>TR13LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <results_first_submitted>February 27, 2023</results_first_submitted>
  <results_first_submitted_qc>March 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2023</results_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CD122-Biased Agonist</keyword>
  <keyword>CD122-Biased Cytokine</keyword>
  <keyword>IL-2 Receptor Agonist</keyword>
  <keyword>NKTR-214</keyword>
  <keyword>Bempegaldesleukin</keyword>
  <keyword>IL-2</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>BEMPEG</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>Opdivo®</keyword>
  <keyword>NIVO</keyword>
  <keyword>Adjuvant</keyword>
  <keyword>Skin Cancer</keyword>
  <keyword>Resectable Melanoma</keyword>
  <keyword>High Risk of Recurrence Melanoma</keyword>
  <keyword>Post Resection</keyword>
  <keyword>Checkpoint Inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04410445/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 15, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04410445/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
          <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
        </group>
        <group group_id="P2">
          <title>Nivolumab</title>
          <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="378"/>
                <participants group_id="P2" count="387"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="348"/>
                <participants group_id="P2" count="363"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
          <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
        </group>
        <group group_id="B2">
          <title>Nivolumab</title>
          <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="378"/>
            <count group_id="B2" value="387"/>
            <count group_id="B3" value="765"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" spread="14.21"/>
                    <measurement group_id="B2" value="56" spread="13.45"/>
                    <measurement group_id="B3" value="55.5" spread="13.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="310"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                    <measurement group_id="B2" value="239"/>
                    <measurement group_id="B3" value="455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="326"/>
                    <measurement group_id="B2" value="323"/>
                    <measurement group_id="B3" value="649"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="354"/>
                    <measurement group_id="B2" value="357"/>
                    <measurement group_id="B3" value="711"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG</title>
          <description>Measure Description: Eastern Cooperative Oncology Group (ECOG) performance status:&#xD;
ECOG Performance Status of 0 = Able to carry out all normal activities without restriction ECOG Performance Status of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ECOG 0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                    <measurement group_id="B2" value="351"/>
                    <measurement group_id="B3" value="702"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.</title>
        <description>Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.</description>
        <time_frame>Up to 21 months</time_frame>
        <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no aggregate blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.</title>
          <description>Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.</description>
          <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no aggregate blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone</title>
        <description>Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive.</description>
        <time_frame>Up to 21 months</time_frame>
        <population>For this outcome measure, the results were not estimable due to insufficient number of events. The study was terminated early due to the closure of the bempegaldesleukin clinical program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone</title>
          <description>Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive.</description>
          <population>For this outcome measure, the results were not estimable due to insufficient number of events. The study was terminated early due to the closure of the bempegaldesleukin clinical program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="387"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="16.9" upper_limit="NA">Median and upper CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.</title>
        <description>Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry.</description>
        <time_frame>Up to 21 months</time_frame>
        <population>Participants include only patients who have Stage III melanoma at study entry. The results were not estimable due to insufficient number of events. The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma.</population>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.</title>
          <description>Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry.</description>
          <population>Participants include only patients who have Stage III melanoma at study entry. The results were not estimable due to insufficient number of events. The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="347"/>
                <count group_id="O2" value="355"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first.</description>
        <time_frame>Approximately up to 21 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="387"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients who had a TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="370"/>
                    <measurement group_id="O2" value="330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients who had a Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients who had a TEAE of Grade 3 or higher</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients who had a TEAE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire</title>
        <description>The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment.</description>
        <time_frame>From baseline, up to approximately 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire</title>
          <description>The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="387"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global Health Status/QoL at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.20" spread="16.284"/>
                    <measurement group_id="O2" value="79.83" spread="15.698"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Health Status/QoL at 6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.31" spread="17.342"/>
                    <measurement group_id="O2" value="78.40" spread="16.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Health Status/QoL Changes at 6 Months from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.71" spread="16.933"/>
                    <measurement group_id="O2" value="-1.48" spread="16.921"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning Subscale at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.81" spread="13.159"/>
                    <measurement group_id="O2" value="91.96" spread="13.515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning Subscale at 6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.52" spread="12.417"/>
                    <measurement group_id="O2" value="91.16" spread="15.591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning Subscale Changes at 6 Months from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.41" spread="12.168"/>
                    <measurement group_id="O2" value="-1.85" spread="13.861"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)</title>
        <description>The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level.</description>
        <time_frame>Up to 21 months</time_frame>
        <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no aggregate blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)</title>
          <description>The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level.</description>
          <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no aggregate blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.</title>
        <description>Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first.</description>
        <time_frame>Up to 21 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.</title>
          <description>Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="387"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="14.3" upper_limit="NA">Median and upper CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab</title>
        <description>Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date.</description>
        <time_frame>Up to 21 months</time_frame>
        <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no data were collected for this efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab</title>
          <description>Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date.</description>
          <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no data were collected for this efficacy endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.</title>
        <description>Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry.</description>
        <time_frame>Up to 21 months</time_frame>
        <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bempegaldesleukin (NKTR-214) + Nivolumab</title>
            <description>Arm A: bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) infusion in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients &lt;40 kg) were administrated every 3 weeks q3w).</description>
          </group>
          <group group_id="O2">
            <title>Nivolumab</title>
            <description>Arm B: Nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients &lt; 40 kg) every 4 weeks (q4w).</description>
          </group>
        </group_list>
        <measure>
          <title>Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.</title>
          <description>Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry.</description>
          <population>The study was terminated early due to the closure of the bempegaldesleukin clinical development program due to lack of enhanced efficacy being observed in combination with nivolumab therapy over nivolumab monotherapy for metastatic melanoma. As a consequence, no blinded independent central review data were collected; no comparative analyses between bempegaldesleukin + nivolumab arm vs nivolumab arm were conducted for this efficacy endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s), up to a maximum of approximately 21 months. All ongoing non-serious AEs will be followed until resolution, the patient is lost to follow-up, patient death, or until the last Safety Follow-Up Visit. If the AE has not completely resolved by the last Safety Follow-Up Visit, the final outcome of these ongoing AEs will be captured.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Combination of Bempegaldesleukin (NKTR-214) + Nivolumab</title>
          <description>Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.&#xD;
Bempegaldesleukin: Specified dose on specified days&#xD;
Nivolumab: Specified dose on specified days</description>
        </group>
        <group group_id="E2">
          <title>Nivolumab</title>
          <description>Arm B: Participants will receive nivolumab IV alone every 4 weeks.&#xD;
Nivolumab: Specified dose on specified days</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pleuropericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune thyroiditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Primary adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness transient</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hepatic mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Infected seroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Myelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Capillary permeability increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Troponin T increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Myopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Lacunar stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Autoimmune nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Lymphocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Poor venous access</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="369" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="329" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="106" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="101" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="160" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="154" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="112" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="114" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="85" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="95" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="387"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="378"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="387"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Nektar Therapeutics</organization>
      <phone>855-482-8676</phone>
      <email>StudyInquiry@nektar.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410445
org study id: 20-214-29/CA045-022
nct id: NCT04410445
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab
      versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous
      melanoma who are at high risk for recurrence.
The main purpose of this study is to compare the efficacy, as measured by recurrence-free
      survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus
      nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN]
      metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC]
      8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for
      recurrence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized in a 1:1 ratio to one of two treatment arms
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
time frame: Up to 21 months
description: Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.
measure: Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone
time frame: Up to 21 months
description: Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive.
measure: Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
time frame: Up to 21 months
description: Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: Approximately up to 21 months
description: To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients <40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients < 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first.
measure: Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire
time frame: From baseline, up to approximately 6 months
description: The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment.
measure: Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)
time frame: Up to 21 months
description: The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level.
measure: Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
time frame: Up to 21 months
description: Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first.
measure: Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab
time frame: Up to 21 months
description: Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date.
measure: Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.
time frame: Up to 21 months
description: Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry.
arm group label: Combination of bempegaldesleukin (NKTR-214) + nivolumab
arm group type: Experimental
description: Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
arm group label: Nivolumab
arm group type: Active Comparator
description: Arm B: Participants will receive nivolumab IV alone every 4 weeks.
intervention type: Biological
intervention name: Bempegaldesleukin
description: Specified dose on specified days
arm group label: Combination of bempegaldesleukin (NKTR-214) + nivolumab
other name: NKTR-214
other name: BMS-986321
intervention type: Biological
intervention name: Nivolumab
description: Specified dose on specified days
arm group label: Combination of bempegaldesleukin (NKTR-214) + nivolumab
arm group label: Nivolumab
other name: Opdivo®
other name: BMS-936558
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Nektar Therapeutics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: Czechia
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Netherlands
country: New Zealand
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Recurrence
mesh term: Nivolumab
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 