<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/NCT02988843</url>
  </required_header>
  <id_info>
    <org_study_id>2015LS190</org_study_id>
    <nct_id>NCT02988843</nct_id>
  </id_info>
  <brief_title>Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors</brief_title>
  <official_title>Phase II Study of Brentuximab Vedotin and Bevacizumab in Men With Refractory CD-30 Positive Germ Cell Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab&#xD;
      for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on&#xD;
      imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP)&#xD;
      or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and&#xD;
      determined by treating physician to be clinically significant. Patients unable to receive 2nd&#xD;
      line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding Unavailable&#xD;
  </why_stopped>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.&#xD;
In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Progression Free Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Were Alive at 2 Years - Overall Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants who were alive at 2 years (Overall survival)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Adverse Events (AE) and Severe Adverse Events (SAE)</measure>
    <time_frame>2 Years</time_frame>
    <description>Safety/ toxicity of brentuximab vedotin, measured by incidence of AEs/SAEs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Germ Cell Tumor</condition>
  <arm_group>
    <arm_group_label>Brentuximab Vedotin &amp; Bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.&#xD;
Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brentuximab Vedotin</intervention_name>
    <description>Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)</description>
    <arm_group_label>Brentuximab Vedotin &amp; Bevacizumab</arm_group_label>
    <other_name>ADCETRIS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>15 mg/kg every 21 days</description>
    <arm_group_label>Brentuximab Vedotin &amp; Bevacizumab</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, ≥ 18 years of age&#xD;
&#xD;
          -  Diagnosis of CD-30 positive germ cell tumor. CD30 expression will be tested by&#xD;
             immunohistochemistry (IHC) in archival or fresh tumor tissue as is routinely done for&#xD;
             diagnosis.&#xD;
&#xD;
          -  Disease progression on imaging or tumor marker progression (clinical significance of&#xD;
             tumor marker progression to be decided per the discretion of treating physician) after&#xD;
             at least 2 lines of platinum-based chemotherapies unless patient is ineligible for&#xD;
             further platinum based chemotherapy or refuses 2nd line platinum based chemotherapy&#xD;
             due to toxicity. For primary mediastinal germ cell tumors, failure of first-line&#xD;
             chemotherapy will be accepted. Prior high dose chemotherapy with hematopoietic stem&#xD;
             cell rescue is allowed. Prior treatment with bevacizumab is allowed.&#xD;
&#xD;
          -  At least 3 weeks should have elapsed since the last treatment (e.g. chemotherapy,&#xD;
             targeted small molecule therapy, immunotherapy or radiation) and must have recovered&#xD;
             to grade 1 or better from the acute effects of prior therapy.&#xD;
&#xD;
          -  Presence of measurable disease according to RECIST 1.1&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  Adequate marrow and organ function within 28 days prior to study registration as&#xD;
             defined below:&#xD;
&#xD;
               -  Leukocytes &gt; 3,000/µL&#xD;
&#xD;
               -  ANC &gt; 1500/µL&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL, Note: Blood transfusion will be allowed for patients with&#xD;
                  hemoglobin &lt; 9 g/dl and G-CSF is allowed for neutropenic patients at time of&#xD;
                  enrollment.&#xD;
&#xD;
               -  Platelets &gt; 100,000/mm3&#xD;
&#xD;
               -  Creatinine: ≤3mg/dl OR if serum creatinine &gt; 3 mg/dl, estimated GFR &gt;30&#xD;
                  mL/min/1.73m2&#xD;
&#xD;
               -  INR: &lt;1.5 x institutional upper limit of normal OR &lt; 3 if on warfarin or other&#xD;
                  anticoagulants. There should be no evidence of active bleeding while on&#xD;
                  anticoagulants.&#xD;
&#xD;
               -  Total bilirubin: ≤ 2 x institutional upper limit of normal (ULN)&#xD;
&#xD;
               -  SGOT (AST) or SGPT (ALT): &lt; 3 x institutional upper limit of normal (&lt; 5 x ULN if&#xD;
                  liver metastases present)&#xD;
&#xD;
               -  Proteinuria: If patient has proteinuria, it should be &lt;2+ (&lt; 100 mg/dl or per&#xD;
                  institutional guidelines). If proteinuria is 2+ or greater (≥ 100 mg/dl per&#xD;
                  institutional guidelines), patients should undergo a 24- hour urine collection&#xD;
                  and 24 hour urinary protein should be less than &lt; 2 grams.&#xD;
&#xD;
          -  Sexually active men with partners of women of childbearing potential must agree to&#xD;
             practice effective methods of contraception during the study and for 6 months after&#xD;
             the last treatment&#xD;
&#xD;
          -  Provide voluntary written consent and HIPAA authorization for release of personal&#xD;
             health information, approved by an Institutional Review Board/Independent Ethics&#xD;
             Committee (IRB/IEC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with Brentuximab Vedotin.&#xD;
&#xD;
          -  Known active brain metastases and or carcinomatous meningitis. Subjects with&#xD;
             previously treated brain metastases may participate provided brain metastases are&#xD;
             stable (without evidence of progression by imaging for at least four weeks prior to&#xD;
             the first dose of trial treatment and any neurologic symptoms have returned to&#xD;
             baseline), have no evidence of new or enlarging brain metastases, and are not using&#xD;
             steroids for at least 7 days prior to study registration. This exception does not&#xD;
             include carcinomatous meningitis, which is excluded regardless of clinical stability.&#xD;
&#xD;
          -  History of blood clots, pulmonary embolism, or deep vein thrombosis in previous 6&#xD;
             months unless controlled by anticoagulant treatment&#xD;
&#xD;
          -  Known history of HIV&#xD;
&#xD;
          -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA&#xD;
             [qualitative] is detected)&#xD;
&#xD;
          -  Received a live vaccine within 1 week prior to the first dose of study treatment&#xD;
&#xD;
          -  Has active autoimmune disease that required systemic treatment with use of disease&#xD;
             modifying agents, corticosteroids or immunosuppressive drugs&#xD;
&#xD;
          -  Any clinically significant active infection that requires systemic treatment at the&#xD;
             time of enrollment.&#xD;
&#xD;
          -  Known allergy to bevacizumab or brentuximab vedotin or any of its excipients&#xD;
&#xD;
          -  Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,&#xD;
             sustained ventricular tachycardia, ventricular fibrillation, clinically significant&#xD;
             bradycardia, advanced heart block or a history of acute myocardial infarction (MI)&#xD;
             within 6 months of study registration&#xD;
&#xD;
          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess&#xD;
             in previous 6 months&#xD;
&#xD;
          -  Prior major surgery within the previous 28 days of study registration and/or presence&#xD;
             of any non-healing wound, fracture, or ulcer.&#xD;
&#xD;
          -  Use of an investigational agent within the previous 28 days of study registration.&#xD;
&#xD;
          -  Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150 mmHg&#xD;
             and/or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of&#xD;
             antihypertensive medication(s) is permitted prior to study registration&#xD;
&#xD;
          -  Arterial thromboembolic events, including transient ischemic attack (TIA),&#xD;
             cerebrovascular accident (CVA), unstable angina, or MI within 6 months of study&#xD;
             registration&#xD;
&#xD;
          -  History of posterior reversible encephalopathy syndrome&#xD;
&#xD;
          -  Other malignancies unless the patient is considered to be disease-free and has&#xD;
             completed therapy for the malignancy &gt; than 6 months prior to study entry&#xD;
&#xD;
          -  Any serious and/or unstable pre-existing medical, psychiatric, or other condition that&#xD;
             could interfere with subject's safety, provision of informed consent, or compliance to&#xD;
             study procedures&#xD;
&#xD;
          -  Concurrent use of rifampin or ketoconazole&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shilpa Gupta</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>November 12, 2020</results_first_submitted>
  <results_first_submitted_qc>November 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 10, 2020</results_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Germ Cell and Embryonal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Brentuximab Vedotin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02988843/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Brentuximab Vedotin &amp; Bevacizumab</title>
          <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.&#xD;
Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.&#xD;
Brentuximab Vedotin: Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)&#xD;
Bevacizumab: 15 mg/kg every 21 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Brentuximab Vedotin &amp; Bevacizumab</title>
          <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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>
          <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="1"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.</title>
        <description>Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.&#xD;
In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Brentuximab Vedotin &amp; Bevacizumab</title>
            <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.</title>
          <description>Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.&#xD;
In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Complete Remission</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Progressive disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Progression Free Survival</title>
        <description>Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Brentuximab Vedotin &amp; Bevacizumab</title>
            <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Progression Free Survival</title>
          <description>Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Were Alive at 2 Years - Overall Survival</title>
        <description>Number of participants who were alive at 2 years (Overall survival)</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Brentuximab Vedotin &amp; Bevacizumab</title>
            <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Alive at 2 Years - Overall Survival</title>
          <description>Number of participants who were alive at 2 years (Overall survival)</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Adverse Events (AE) and Severe Adverse Events (SAE)</title>
        <description>Safety/ toxicity of brentuximab vedotin, measured by incidence of AEs/SAEs</description>
        <time_frame>2 Years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Brentuximab Vedotin &amp; Bevacizumab</title>
            <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events (AE) and Severe Adverse Events (SAE)</title>
          <description>Safety/ toxicity of brentuximab vedotin, measured by incidence of AEs/SAEs</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="1"/>
              </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_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Brentuximab Vedotin &amp; Bevacizumab</title>
          <description>Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</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="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Shilpa Gupta</name_or_title>
      <organization>Masonic Cancer Center, University of Minnesota</organization>
      <phone>612 624 0123</phone>
      <email>guptash@umn.edu</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/NCT02988843
org study id: 2015LS190
nct id: NCT02988843
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab
      for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on
      imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP)
      or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and
      determined by treating physician to be clinically significant. Patients unable to receive 2nd
      line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.
time frame: 1 year
description: Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.
measure: Number of Participants Experiencing Progression Free Survival
time frame: 2 years
description: Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression
measure: Number of Participants Who Were Alive at 2 Years - Overall Survival
time frame: 2 years
description: Number of participants who were alive at 2 years (Overall survival)
measure: Number of Participants Experiencing Adverse Events (AE) and Severe Adverse Events (SAE)
time frame: 2 Years
description: Safety/ toxicity of brentuximab vedotin, measured by incidence of AEs/SAEs
arm group label: Brentuximab Vedotin & Bevacizumab
arm group type: Experimental
description: Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.
Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.
intervention type: Drug
intervention name: Brentuximab Vedotin
description: Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)
arm group label: Brentuximab Vedotin & Bevacizumab
other name: ADCETRIS
intervention type: Drug
intervention name: Bevacizumab
description: 15 mg/kg every 21 days
arm group label: Brentuximab Vedotin & Bevacizumab
other name: Avastin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shilpa Gupta
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms, Germ Cell and Embryonal
mesh term: Bevacizumab
mesh term: Brentuximab Vedotin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 