<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/NCT04498117</url>
  </required_header>
  <id_info>
    <org_study_id>QPT-ORE-005</org_study_id>
    <secondary_id>GOG-3035</secondary_id>
    <secondary_id>FLORA-5</secondary_id>
    <secondary_id>FLORA5</secondary_id>
    <nct_id>NCT04498117</nct_id>
  </id_info>
  <brief_title>Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery</brief_title>
  <acronym>FLORA-5</acronym>
  <official_title>A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CanariaBio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gynecologic Oncology Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CanariaBio Inc.</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>
      Study to compare the safety and efficacy of oregovomab versus placebo, administered in&#xD;
      combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and&#xD;
      carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who&#xD;
      have undergone optimal debulking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and&#xD;
      efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in&#xD;
      combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and&#xD;
      carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have&#xD;
      undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort&#xD;
      1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already&#xD;
      completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).&#xD;
&#xD;
      For Cohort 1 - Primary Surgery, approximately 372 subjects randomized in a 1:1 ratio (i.e.,&#xD;
      chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval&#xD;
      Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy&#xD;
      with oregovomab or chemotherapy and placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">August 26, 2027</completion_date>
  <primary_completion_date type="Anticipated">September 26, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator Assessed Progression Free Survival</measure>
    <time_frame>Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 6 years.</time_frame>
    <description>Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Date of randomization up until date of death from any cause, up to approximately 11 years</time_frame>
    <description>Date of randomization to the date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>Date of randomization up until date of discontinuation of treatment, date of significant physical examination changes, date of significant clinical changes, up to approximately 6 years</time_frame>
    <description>Incidence of adverse events (AEs) leading to discontinuation of treatment, frequency/severity of vital signs measurements, physical examination findings, and changes in clinical laboratory parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years</time_frame>
    <description>Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O TOI)&#xD;
Three additional questions from the NFOSI-18 in each treatment group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Efficacy by times to subsequent therapies and time to next progression</measure>
    <time_frame>Date of randomization, until date of subsequent therapy or death, or up to approximately 6 years</time_frame>
    <description>Tumor response measurement by iRECIST&#xD;
Time to First Subsequent Therapy (TFST), defined as tie form the date of randomization to first subsequent anti-cancer therapy or death&#xD;
Time to Second Subsequent Therapy, defined as time from the date of randomization to second anti-cancer therapy start date or death&#xD;
Progression Free Survival 2, defined from the date of randomization to the first documented progression on next-line therapy or death.</description>
  </other_outcome>
  <other_outcome>
    <measure>Potential Biomarkers</measure>
    <time_frame>Date of randomization, until date of discontinuation, or up to approximately 6 years</time_frame>
    <description>Human Anti-Mouse Antibody (HAMA)&#xD;
HAMA interference-free CA-125&#xD;
Neutrophil + Monocyte to Lymphocyte Ratio (NMLR)&#xD;
Phenotyping or immune subsets, including myeloid-derived suppressor cells (MDSC)&#xD;
Functional assessment of CD4+ and CD8+ T-cells with a focus on measuring the number and frequency of INF-y-producing CD8+ T-cells using flow cytometry</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">615</enrollment>
  <condition>Carcinoma, Ovarian Epithelial</condition>
  <condition>Ovarian Neoplasms</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Ovarian Serous Adenocarcinoma</condition>
  <condition>Fallopian Tube Neoplasms</condition>
  <condition>Fallopian Tube Adenocarcinoma</condition>
  <condition>Fallopian Tube Serous Adenocarcinoma</condition>
  <condition>Peritoneal Cancer</condition>
  <condition>Peritoneal Carcinoma</condition>
  <condition>Peritoneal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Cohort 1- Surgery Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 - Primary Surgery Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Six (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Oregovomab</intervention_name>
    <description>2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes</description>
    <arm_group_label>Cohort 1- Surgery Active</arm_group_label>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Active</arm_group_label>
    <other_name>MAb-B43.13</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>175 mg/m^2, every 3 weeks</description>
    <arm_group_label>Cohort 1 - Primary Surgery Control</arm_group_label>
    <arm_group_label>Cohort 1- Surgery Active</arm_group_label>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Active</arm_group_label>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Control</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>AUC 6 IV Day 1 x 6 cycles (every 21 days)</description>
    <arm_group_label>Cohort 1 - Primary Surgery Control</arm_group_label>
    <arm_group_label>Cohort 1- Surgery Active</arm_group_label>
    <other_name>Paraplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes</description>
    <arm_group_label>Cohort 1 - Primary Surgery Control</arm_group_label>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>AUC 5-6 IV Day 1 x 6 cycles (every 21 days)</description>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Active</arm_group_label>
    <arm_group_label>Cohort 2 - NACT + Interval Surgery Control</arm_group_label>
    <other_name>Paraplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults 18 years old or older.&#xD;
&#xD;
          2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal&#xD;
             origin FIGO Stage III or IV disease.&#xD;
&#xD;
          3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade&#xD;
             endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma,&#xD;
             mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).&#xD;
&#xD;
          4. Completed debulking surgery (either primary debulking surgery or interval debulking&#xD;
             surgery at the discretion of the investigator). Debulking surgery must be optimal, R1&#xD;
             or R0 (defined as R1, macroscopic less than 1 cm in diameter, or R0, microscopic or no&#xD;
             evidence of tumor). Assessment of debulking surgery will be determined at the time of&#xD;
             the surgical procedure, not by post-surgical imaging.&#xD;
&#xD;
               1. For Cohort 1, subject will undergo primary debulking surgery. Subject must&#xD;
                  receive initial dose of paclitaxel 175 mg/m^2 given intravenously and carboplatin&#xD;
                  AUC 6 IV every 3 weeks for 6 cycles. Carboplatin total dose given as 5&#xD;
                  consecutive daily pulse doses, for subjects who experiences significant grade 3&#xD;
                  or higher emesis. Subsequent dose modifications will be instituted per protocol.&#xD;
                  Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within&#xD;
                  6 weeks after primary debulking surgery&#xD;
&#xD;
               2. For Cohort 2, subject will undergo interval debulking surgery (IDS). Prior to&#xD;
                  IDS, subjects must have receive 3 cycles of paclitaxel and carboplatin as&#xD;
                  neoadjuvant treatment. After IDS, subjects must receive paclitaxel 175 mg/m^2 IV&#xD;
                  and carboplatin AUC 5-6 IV every 3 weeks, starting cycle 4. Cycle 4 of&#xD;
                  chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks&#xD;
                  after IDS.&#xD;
&#xD;
          5. Suitable venous access for the study-required procedures&#xD;
&#xD;
          6. Preoperative serum CA-125 levels ≥ 50 U/mL for Cohort 1, serum CA-125 levels ≥ 50 U/mL&#xD;
             prior to first neoadjuvant chemotherapy for Cohort 2.&#xD;
&#xD;
          7. Adequate bone marrow function:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1,500/µL&#xD;
&#xD;
               2. Platelets ≥ 100,000/µL&#xD;
&#xD;
          8. Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before&#xD;
             first dose of study treatment).&#xD;
&#xD;
          9. Adequate liver function:&#xD;
&#xD;
               1. Bilirubin &lt; 1.5 times upper limit normal (ULN)&#xD;
&#xD;
               2. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT &lt; 2.5 times ULN&#xD;
&#xD;
         10. Adequate renal function:&#xD;
&#xD;
             a. Creatinine ≤ 1.5 times ULN&#xD;
&#xD;
         11. ECOG Performance Status of 0 or 1.&#xD;
&#xD;
         12. For women of childbearing potential, must be willing to avoid pregnancy by using&#xD;
             highly effective method of contraception from the first dose of study treatment to 6&#xD;
             months after last dose of study treatment as defined per protocol. Belgium and South&#xD;
             Korea only: Use of a highly effective method of contraception from 28 days before&#xD;
             first dose.&#xD;
&#xD;
         13. Signed informed consent and authorization permitting release of personal health&#xD;
             information.&#xD;
&#xD;
         14. Willingness and ability to complete patient quality of life questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. BRCA1 or BRCA2 germline gene mutation test result with:&#xD;
&#xD;
               1. Pathogenic, ambiguous or inconclusive result available within 28 days prior to&#xD;
                  starting study treatment (subjects with BRCA1 or BRCA 2 variants of uncertain&#xD;
                  significance can enroll onto the study as long as there is no intent to&#xD;
                  administer PARP inhibitors for front-line maintenance therapy), or&#xD;
&#xD;
               2. Known BRCA1 and BRCA2 somatic mutations, if testing is performed&#xD;
&#xD;
          2. Known Somatic Homologous Recombination Deficiency (HRD) who will receive PARP&#xD;
             inhibitor front-line maintenance therapy. Subjects with somatic HRD are eligible as&#xD;
             long as there is no intent to administer PARP inhibitor front-line maintenance&#xD;
             therapy.&#xD;
&#xD;
          3. Subjects with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine&#xD;
             features and low-grade adenocarcinoma.&#xD;
&#xD;
          4. Female subjects who are lactating and breastfeeding, or have a positive serum&#xD;
             pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for&#xD;
             Cohort 1 or C4D1 for Cohort 2).&#xD;
&#xD;
          5. Any serious medical or psychiatric illness that could, in the investigator's opinion,&#xD;
             potentially interfere with the completion of treatment according to this protocol.&#xD;
&#xD;
          6. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus&#xD;
             (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing&#xD;
             spondylitis requiring active disease modifying treatment.&#xD;
&#xD;
          7. Known allergy to murine proteins or hypersensitivity to any of the excipients of the&#xD;
             oregovomab, paclitaxel, or carboplatin.&#xD;
&#xD;
          8. Chronically treated with immunosuppressive drugs such as cyclosporine,&#xD;
             adrenocorticotropic hormone (ACTH), etc.&#xD;
&#xD;
          9. Chronic therapeutic corticosteroid use, defined as &gt; 5 days of prednisone or&#xD;
             equivalent, with the exception of inhalers or those on a pre-planned steroid taper.&#xD;
             (Note: Premedication with corticosteroids per institutional standard of care is&#xD;
             allowed.)&#xD;
&#xD;
         10. Recognized acquired, hereditary, or congenital immunodeficiency disease, including&#xD;
             cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.&#xD;
&#xD;
         11. Clinically significant active infection(s) at the time of screening.&#xD;
&#xD;
         12. Any of the following conditions (on-study testing is not required unless it is&#xD;
             required by a specific participating country):&#xD;
&#xD;
               1. Known HIV-infected subjects unless on effective anti-retroviral therapy with an&#xD;
                  undetectable viral load within 6 months, or&#xD;
&#xD;
               2. Known or suspected hepatitis B if active infection (subjects with chronic&#xD;
                  hepatitis B infection must have an undetectable HBV viral load on suppressive&#xD;
                  therapy, if indicated; positive surface antibody alone is not an exclusion), or&#xD;
&#xD;
               3. Known or suspected hepatitis C infection which has not been treated and cured&#xD;
                  unless currently on treatment with an undetectable viral load).&#xD;
&#xD;
         13. Uncontrolled or life-threatening diseases compromising safety evaluation.&#xD;
&#xD;
         14. Diagnosed or treated for another malignancy within 5 years before the first dose, or&#xD;
             previously diagnosed with another malignancy and have any evidence of residual disease&#xD;
             including ductal carcinoma in situ of the breast. Subjects with non-melanoma skin&#xD;
             cancer, other carcinoma in situ if have undergone complete resection or cervix&#xD;
             carcinoma in situ are not excluded if they have undergone complete resection.&#xD;
             Synchronous endometrial and prior diagnosis of endometrial cancer within 5 years is&#xD;
             not excluded if all of the following conditions are met: Stage IA, superficial&#xD;
             myometrial invasion, without lymphovascular invasion, and not poorly differentiated&#xD;
             subtypes including papillary serous, clear cell lesions.&#xD;
&#xD;
         15. Contraindications to the use of pressor agents.&#xD;
&#xD;
         16. Undergone more than one surgical debulking or have not recovered from surgery.&#xD;
&#xD;
         17. Anticipated treatment with any other anti-cancer medications, including bevacizumab,&#xD;
             PARP inhibitors, or any investigational agent(s) during the study.&#xD;
&#xD;
         18. History or evidence upon physical examination of CNS disease, seizures not controlled&#xD;
             with standard medical therapy, or any brain metastases.&#xD;
&#xD;
         19. Any of the following cardiovascular conditions:&#xD;
&#xD;
               1. Acute myocardial infarction within 6 months before the first dose of study&#xD;
                  treatment.&#xD;
&#xD;
               2. Current history of New York Heart Association (NYHA) Class III or IV heart&#xD;
                  failure.&#xD;
&#xD;
               3. Evidence of current uncontrolled cardiovascular conditions including cardiac&#xD;
                  arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically&#xD;
                  significant findings.&#xD;
&#xD;
         20. Unable to read or understand or unable to sign the necessary written consent before&#xD;
             starting treatment.&#xD;
&#xD;
         21. May not receive any live, attenuated vaccine administered within 28 days (or 4 weeks)&#xD;
             prior to enrollment, during the study, and for at least 90 days after the last dose of&#xD;
             study treatment.&#xD;
&#xD;
         22. Subjects who receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), any other&#xD;
             anti-cancer medications, including bevacizumab, PARP inhibitors, or any other&#xD;
             investigational agent(s) with 3 cycles of paclitaxel and carboplatin neoadjuvant&#xD;
             treatment prior to IDS.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sunil Gupta, MD, FRCPC</last_name>
    <role>Study Director</role>
    <affiliation>CanariaBio Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Honor Health</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Muir Health Clinical Research Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Southern California</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moores UC San Diego Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Los Angeles Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care</name>
      <address>
        <city>Pleasant Hill</city>
        <state>California</state>
        <zip>94523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Riverside Medical Center</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>95505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Contra Costa Oncology</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Muir Health Gynecologic Cancer Services</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Health</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Connecticut Health Center</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Florida/Women's Cancer Associates</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewis Cancer &amp; Research Pavilion at St. Joseph's Candler</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Queens Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children/University of Hawaii</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Research Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Care/Mary Bird Perkins Cancer Center</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital and Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroWest Medical Center</name>
      <address>
        <city>Framingham</city>
        <state>Massachusetts</state>
        <zip>01702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lowell General Hospital</name>
      <address>
        <city>Lowell</city>
        <state>Massachusetts</state>
        <zip>01854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center Cancer Center in Stoneham</name>
      <address>
        <city>Stoneham</city>
        <state>Massachusetts</state>
        <zip>02180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology - Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Health - Maple Grove Clinic</name>
      <address>
        <city>Maple Grove</city>
        <state>Minnesota</state>
        <zip>55369</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Minnesota Community Oncology Research Consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Frauenshuh Cancer Center</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portsmouth Regional Hospital</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Valley Hospital (Valley Health)</name>
      <address>
        <city>Paramus</city>
        <state>New Jersey</state>
        <zip>07450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womens Cancer Care Associates</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center PRIME</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai - PRIME</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai The Blavatnik Family Chelsea Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</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>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Women's Cancer Care Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCC at UH Geauga Medical Center</name>
      <address>
        <city>Chardon</city>
        <state>Ohio</state>
        <zip>44024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Fairview Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grandview Medical Center/Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Hillcrest Hospital</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UH Minoff Health Center - Seidman</name>
      <address>
        <city>Orange Village</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCC at St. John's Medical Center</name>
      <address>
        <city>Westlake</city>
        <state>Ohio</state>
        <zip>44145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cancer Specialist and Research Institution, LLC</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute and Research Center</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists, P.C.-Portland-Rose Quarter</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee Women's Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Pennsylvania Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center at UPMC Passavant</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15237-9643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women &amp; Infants Hospital of Rhode Island</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Research/USD-Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Herman Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology San Antonio Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health Systems</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>21055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates - Hampton</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic Gynecological Oncology</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Regional Cancer Center - Auburn</name>
      <address>
        <city>Auburn</city>
        <state>Washington</state>
        <zip>98001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Regional Cancer Center-Gig Harbor Medical Park</name>
      <address>
        <city>Gig Harbor</city>
        <state>Washington</state>
        <zip>98335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research and Innovation</name>
      <address>
        <city>Puyallup</city>
        <state>Washington</state>
        <zip>98372</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Regional Cancer Center - Tacoma</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>CEMAIC - Centro Medico Privado</name>
      <address>
        <city>Córdoba</city>
        <state>Cordoba</state>
        <zip>2941</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universitaria Privada Reina Fabiola</name>
      <address>
        <city>Córdoba</city>
        <state>Cordoba</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio de la Mujer</name>
      <address>
        <city>Rosario</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Parque S.A</name>
      <address>
        <city>Salta</city>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CER San Juan Centro Polivalente de Asistencia e Inv. Clinica</name>
      <address>
        <city>San Juan</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinicas Viedma S.A.</name>
      <address>
        <city>Viedma</city>
        <zip>R8500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique CHC MontLégia</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisas Clinica Reichow</name>
      <address>
        <city>Blumenau</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncosite - Centro de Pesquisa Clinica e Oncologia</name>
      <address>
        <city>Guimaraes</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Doutor Amaral Carvalho</name>
      <address>
        <city>San Paolo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia</name>
      <address>
        <city>Santo André</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica São Germano - Oncologia</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Health Hospital at Laval (Cité de la Santé de Laval)</name>
      <address>
        <city>Laval</city>
        <state>Quebec</state>
        <zip>H7M 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM Centre de Recherche (affiliated with University of Montreal)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre/Glen Site/ Royal Victoria Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUS - Hôpital Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Clínicos e Investigación Médica (CeCim)</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Clínica Bradford Hill</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedad de Investigaciones Medicas Limitada</name>
      <address>
        <city>Temuco</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Kralovske Vinohrady</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Bulovka</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice v Motole</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvedseg Egeszsegugyi Kozpont</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Margit Korhaz</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bacs-Kiskun Megyei Oktatokorhaz</name>
      <address>
        <city>Kecskemét</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zala Megyei Szent Rafael Korhaz</name>
      <address>
        <city>Zalaegerszeg</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Hospital Ltd</name>
      <address>
        <city>Bangalore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Hospital Ltd</name>
      <address>
        <city>Bengaluru</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Services</name>
      <address>
        <city>Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Max Super Specialty Hospital</name>
      <address>
        <city>Mohali</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sushrut Hospital</name>
      <address>
        <city>Mumbai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vardhan Mahavir Medical College and Safdarjung Hospital</name>
      <address>
        <city>New Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Hospital</name>
      <address>
        <city>Noida</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deenanath Mangeshkar Hospital</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruby Hall Clinic</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Clinicizzato SS. Annunziata</name>
      <address>
        <city>Chieti</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università Campus Bio-Medico di Roma</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea Univ Anam Hsp</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System</name>
      <address>
        <city>Soeul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Medical Research S.C.</name>
      <address>
        <city>Orizaba</city>
        <state>Veracruz</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)</name>
      <address>
        <city>La Paz</city>
        <zip>23040</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karla Adriana Espinosa Bautista</name>
      <address>
        <city>Mexico</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMIQ S. de R.L. de C.V.</name>
      <address>
        <city>Querétaro</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Potosino de Investigación Medica S.C.</name>
      <address>
        <city>San Luis Potosi</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny w Olsztynie</name>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO l'Hospitalet-Hospital Duran i Reynals</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U. Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncologia IVO</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei county</city>
        <state>Taipei</state>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>70457</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koo Foundation Sun Yat-Sen Cancer Center</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
    <country>Romania</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Cystadenocarcinoma, Serous</mesh_term>
    <mesh_term>Peritoneal Neoplasms</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Oregovomab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498117
org study id: QPT-ORE-005
secondary id: GOG-3035
secondary id: FLORA-5
secondary id: FLORA5
nct id: NCT04498117
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Study to compare the safety and efficacy of oregovomab versus placebo, administered in
      combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and
      carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who
      have undergone optimal debulking.
Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and
      efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in
      combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and
      carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have
      undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort
      1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already
      completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).

      For Cohort 1 - Primary Surgery, approximately 372 subjects randomized in a 1:1 ratio (i.e.,
      chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval
      Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy
      with oregovomab or chemotherapy and placebo).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Investigator Assessed Progression Free Survival
time frame: Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 6 years.
description: Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death
measure: Overall Survival
time frame: Date of randomization up until date of death from any cause, up to approximately 11 years
description: Date of randomization to the date of death
measure: Safety and Tolerability
time frame: Date of randomization up until date of discontinuation of treatment, date of significant physical examination changes, date of significant clinical changes, up to approximately 6 years
description: Incidence of adverse events (AEs) leading to discontinuation of treatment, frequency/severity of vital signs measurements, physical examination findings, and changes in clinical laboratory parameters
measure: Change in Quality of Life
time frame: Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years
description: Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O TOI)
Three additional questions from the NFOSI-18 in each treatment group
measure: Efficacy by times to subsequent therapies and time to next progression
time frame: Date of randomization, until date of subsequent therapy or death, or up to approximately 6 years
description: Tumor response measurement by iRECIST
Time to First Subsequent Therapy (TFST), defined as tie form the date of randomization to first subsequent anti-cancer therapy or death
Time to Second Subsequent Therapy, defined as time from the date of randomization to second anti-cancer therapy start date or death
Progression Free Survival 2, defined from the date of randomization to the first documented progression on next-line therapy or death.
measure: Potential Biomarkers
time frame: Date of randomization, until date of discontinuation, or up to approximately 6 years
description: Human Anti-Mouse Antibody (HAMA)
HAMA interference-free CA-125
Neutrophil + Monocyte to Lymphocyte Ratio (NMLR)
Phenotyping or immune subsets, including myeloid-derived suppressor cells (MDSC)
Functional assessment of CD4+ and CD8+ T-cells with a focus on measuring the number and frequency of INF-y-producing CD8+ T-cells using flow cytometry
arm group label: Cohort 1- Surgery Active
arm group type: Experimental
description: Six (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
arm group label: Cohort 1 - Primary Surgery Control
arm group type: Placebo Comparator
description: Six (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
arm group label: Cohort 2 - NACT + Interval Surgery Active
arm group type: Experimental
description: In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
arm group label: Cohort 2 - NACT + Interval Surgery Control
arm group type: Placebo Comparator
description: In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
intervention type: Biological
intervention name: Oregovomab
description: 2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
arm group label: Cohort 1- Surgery Active
arm group label: Cohort 2 - NACT + Interval Surgery Active
other name: MAb-B43.13
intervention type: Drug
intervention name: Paclitaxel
description: 175 mg/m^2, every 3 weeks
arm group label: Cohort 1 - Primary Surgery Control
arm group label: Cohort 1- Surgery Active
arm group label: Cohort 2 - NACT + Interval Surgery Active
arm group label: Cohort 2 - NACT + Interval Surgery Control
other name: Taxol
intervention type: Drug
intervention name: Carboplatin
description: AUC 6 IV Day 1 x 6 cycles (every 21 days)
arm group label: Cohort 1 - Primary Surgery Control
arm group label: Cohort 1- Surgery Active
other name: Paraplatin
intervention type: Biological
intervention name: Placebo
description: 2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
arm group label: Cohort 1 - Primary Surgery Control
arm group label: Cohort 2 - NACT + Interval Surgery Control
intervention type: Drug
intervention name: Carboplatin
description: AUC 5-6 IV Day 1 x 6 cycles (every 21 days)
arm group label: Cohort 2 - NACT + Interval Surgery Active
arm group label: Cohort 2 - NACT + Interval Surgery Control
other name: Paraplatin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sunil Gupta, MD, FRCPC
role: Study Director
affiliation: CanariaBio Inc.
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country: Argentina
country: Belgium
country: Brazil
country: Canada
country: Chile
country: Czechia
country: Hungary
country: India
country: Italy
country: Korea, Republic of
country: Mexico
country: Poland
country: Spain
country: Taiwan
country: United States
country: China
country: Romania
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Adenocarcinoma
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Cystadenocarcinoma, Serous
mesh term: Peritoneal Neoplasms
mesh term: Fallopian Tube Neoplasms
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Oregovomab
sharing ipd: No