<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/NCT03245736</url>
  </required_header>
  <id_info>
    <org_study_id>GCT1015-03</org_study_id>
    <nct_id>NCT03245736</nct_id>
  </id_info>
  <brief_title>Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.</brief_title>
  <official_title>A Multi-center, Open-label Trial Investigating the Efficacy and Safety of Continued Treatment With Tisotumab Vedotin in Patients With Solid Tumors Known to Express Tissue Factor.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seagen Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genmab</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seagen Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the trial is to evaluate efficacy and safety of continued treatment with&#xD;
      tisotumab vedotin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, multicenter trial to collect long-term safety and efficacy data and to&#xD;
      provide ongoing access to tisotumab vedotin for patients with solid tumors who have completed&#xD;
      a tisotumab vedotin base trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)</measure>
    <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
    <description>Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Increased Cancer Antigen (CA 125) Levels</measure>
    <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
    <description>The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Increased Prostate Specific Antigen (PSA)</measure>
    <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
    <description>The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Ovary Cancer</condition>
  <condition>Cervix Cancer</condition>
  <condition>Endometrium Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Esophagus Cancer</condition>
  <condition>Lung Cancer, Nonsmall Cell</condition>
  <condition>Squamous Cell Carcinoma of the Head and Neck</condition>
  <arm_group>
    <arm_group_label>Tisotumab Vedotin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tisotumab Vedotin</intervention_name>
    <description>All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).</description>
    <arm_group_label>Tisotumab Vedotin</arm_group_label>
    <other_name>TIVDAK</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have either:&#xD;
&#xD;
               1. completed the base trial and have shown a clinical benefit of SD or better and&#xD;
                  have never met any withdrawal criteria as defined in the tisotumab vedotin base&#xD;
                  protocol, or&#xD;
&#xD;
               2. not completed treatment as defined in the base protocol for reasons that are not&#xD;
                  considered critical and unmanageable for the safety of the patient (as evaluated&#xD;
                  by the investigator and/or the sponsor) and the patient clearly showed response&#xD;
                  of PR or better.&#xD;
&#xD;
          -  Patients must not have experienced radiographic disease progression or clinical signs&#xD;
             of symptoms of instability requiring urgent intervention.&#xD;
&#xD;
          -  Patients must not have received any other anti-cancer treatment (including surgery,&#xD;
             radiation or systemic chemotherapy) since the base trial.&#xD;
&#xD;
          -  Acceptable renal function&#xD;
&#xD;
          -  Acceptable liver function&#xD;
&#xD;
          -  Acceptable hematological status&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  A negative serum pregnancy test (if female and aged between 18-55 years old).&#xD;
&#xD;
          -  Patients, both females and males, of reproductive potential must agree to use adequate&#xD;
             contraception during and for six months after the last infusion of tisotumab vedotin.&#xD;
&#xD;
               1. Adequate contraception for women is defined as hormonal birth control or an&#xD;
                  intrauterine device (safe hormonal contraceptives include contraceptive pills,&#xD;
                  implants, transdermal patches, hormonal vaginal devices or injections with&#xD;
                  prolonged release). In countries where two highly effective methods of&#xD;
                  contraception are required this will be an inclusion criterion.&#xD;
&#xD;
               2. Male patients must be willing to use a latex condom during any sexual contact&#xD;
                  with females of childbearing potential during and for six months after the last&#xD;
                  infusion of tisotumab vedotin, even after having undergone a successful&#xD;
                  vasectomy.&#xD;
&#xD;
               3. In order to be considered as sterilized or infertile, a patient must have&#xD;
                  undergone surgical sterilization (vasectomy/bilateral tubectomy; hysterectomy and&#xD;
                  bilateral ovariectomy) or be postmenopausal (12 months or more with no period&#xD;
                  prior to enrolment).&#xD;
&#xD;
          -  Following receipt of verbal and written information about the trial, patients must&#xD;
             provide signed informed consent before any trial-related activity is carried out.&#xD;
&#xD;
          -  Acceptable coagulation status as defined in the applicable base protocol&#xD;
&#xD;
               1. GEN701: Acceptable coagulation status: International normalized ratio (INR) ≤ 1.2&#xD;
                  (without anticoagulant therapy), and activated partial thromboplastin time (aPTT)&#xD;
                  ≤ 1.25 ULN; patients on stable doses of therapeutic anti-coagulative treatment&#xD;
                  for ≥ 8 weeks (e.g., warfarin) must have an INR &lt; 3.&#xD;
&#xD;
               2. GEN702: Acceptable coagulation status defined as: INR ≤ 1.2 (without&#xD;
                  anticoagulant therapy), and aPTT ≤ ULN.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 2&#xD;
             peripheral neuropathy.&#xD;
&#xD;
          -  Clinically significant active viral, bacterial or fungal infection requiring:&#xD;
&#xD;
               1. Intravenous treatment with anti-infective therapy that has been administered less&#xD;
                  than two weeks prior to first dose in this trial, or&#xD;
&#xD;
               2. Oral treatment with anti-infective therapy that has been administered less than&#xD;
                  one week prior to first dose in this trial.&#xD;
&#xD;
               3. Prophylactic anti-infective therapy, which is given without clinical symptoms is&#xD;
                  allowed.&#xD;
&#xD;
          -  Ongoing acute or chronic inflammatory skin disease.&#xD;
&#xD;
          -  Women who are breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Genmab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brian Slomovitz</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johann de Bono</name>
      <address>
        <city>Chelsea</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatson Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Thistlethwaite</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>October 6, 2021</results_first_submitted>
  <results_first_submitted_qc>October 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2021</results_first_posted>
  <disposition_first_submitted>January 14, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>January 14, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 18, 2020</disposition_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2021</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>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tisotumab vedotin</mesh_term>
  </intervention_browse>
  <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>September 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03245736/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>January 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03245736/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants entered the trial following completion of other tisotumab vedotin trials such as GEN701 and GEN702. A total of 5 participants took part in the trial at 3 sites in the United Kingdom and 1 site in the United States from 23 August 2017 to 10 January 2019.</recruitment_details>
      <pre_assignment_details>Six participants were screened, 5 of which were enrolled.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tisotumab Vedotin</title>
          <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tisotumab Vedotin</title>
          <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.4" spread="10.46" lower_limit="10.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>In utero</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preterm newborn infants (gestational age &lt; 37 wks)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Newborns (0-27 days)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Infants and toddlers (28 days-23 months)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Children (2-11 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adolescents (12-17 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adults (18-64 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>From 65-84 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>85 years and over</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.</description>
        <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tisotumab Vedotin</title>
            <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate</title>
        <description>Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.</description>
        <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tisotumab Vedotin</title>
            <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate</title>
          <description>Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Progressive Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Increased Cancer Antigen (CA 125) Levels</title>
        <description>The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.</description>
        <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tisotumab Vedotin</title>
            <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Increased Cancer Antigen (CA 125) Levels</title>
          <description>The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Increased Prostate Specific Antigen (PSA)</title>
        <description>The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.</description>
        <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
        <population>No participants with prostate cancer participated in this trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisotumab Vedotin</title>
            <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Increased Prostate Specific Antigen (PSA)</title>
          <description>The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.</description>
          <population>No participants with prostate cancer participated in this trial.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 to Week 24 plus 30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Overall</title>
          <description>Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>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="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>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="5" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal exudates</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Ocular toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Corneal thinning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Punctate keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </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>
      <restrictive_agreement>All proposed publications and presentations shall be submitted to the sponsor for its review at least 30 days before such presentation or publication is submitted to any third party.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Information</name_or_title>
      <organization>Genmab A/S</organization>
      <phone>70202728</phone>
      <email>clinicaltrials@genmab.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/NCT03245736
org study id: GCT1015-03
nct id: NCT03245736
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the trial is to evaluate efficacy and safety of continued treatment with
      tisotumab vedotin.
This is an open-label, multicenter trial to collect long-term safety and efficacy data and to
      provide ongoing access to tisotumab vedotin for patients with solid tumors who have completed
      a tisotumab vedotin base trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
time frame: Day 1 to Week 24 plus 30 days
description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.
measure: Objective Response Rate
time frame: Day 1 to Week 24 plus 30 days
description: Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.
measure: Number of Participants With Increased Cancer Antigen (CA 125) Levels
time frame: Day 1 to Week 24 plus 30 days
description: The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.
measure: Number of Participants With Increased Prostate Specific Antigen (PSA)
time frame: Day 1 to Week 24 plus 30 days
description: The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.
arm group label: Tisotumab Vedotin
arm group type: Experimental
description: All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.
intervention type: Drug
intervention name: Tisotumab Vedotin
description: All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).
arm group label: Tisotumab Vedotin
other name: TIVDAK
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Genmab
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Uterine Cervical Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Endometrial Neoplasms
mesh term: Tisotumab vedotin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 