<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/NCT03029832</url>
  </required_header>
  <id_info>
    <org_study_id>GO39590</org_study_id>
    <secondary_id>2016-004165-58</secondary_id>
    <nct_id>NCT03029832</nct_id>
  </id_info>
  <brief_title>A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy</brief_title>
  <official_title>A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <oversight_info>
    <has_dmc>No</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 Phase II, multicenter, randomized, placebo-controlled, double-blind study to&#xD;
      evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo&#xD;
      and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma&#xD;
      (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting&#xD;
      and who are ineligible to receive cisplatin-based therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design has been amended after the decision to prematurely stop patient accrual due&#xD;
      to enrollment challenges. As only 5 participants were enrolled, the study blinding will not&#xD;
      be maintained, and placebo infusions will not be administered. Patients assigned to the&#xD;
      MOXR0916 arm may continue study treatment with the combination of atezolizumab and MOXR0916&#xD;
      or with atezolizumab alone based on a discussion of benefit and risk with the treating&#xD;
      investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was prematurely terminated due to slow patient accrual and discontinuation of&#xD;
    clinical development of MOXR0916 due to Sponsor's strategic priorities.&#xD;
  </why_stopped>
  <start_date type="Actual">April 27, 2017</start_date>
  <completion_date type="Actual">April 25, 2018</completion_date>
  <primary_completion_date type="Actual">April 25, 2018</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
    <masking_description>The study design has been amended in that the study blinding will not be maintained.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of &gt;= 5 millimeter (mm) in the sum of diameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response (OR) According to RECIST v1.1</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions &gt;= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOR) According to RECIST v1.1</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot; with the participant's life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot; with the participant's life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Event (AEs)</measure>
    <time_frame>Up to approximately 45 months</time_frame>
    <description>An adverse event is any untoward medical occurrence, regardless of causal attribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab</measure>
    <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
    <description>AUC represents the body's exposure to an administered drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab</measure>
    <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
    <description>Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab</measure>
    <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
    <description>Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance of MOXR0916 and Atezolizumab</measure>
    <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab</measure>
    <time_frame>Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose</time_frame>
    <description>ATAs may be produced by the body in response to an administered drug.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Urothelial Carcinoma</condition>
  <arm_group>
    <arm_group_label>MOXR0916 plus Atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Atezolizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOXR0916</intervention_name>
    <description>MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
    <arm_group_label>MOXR0916 plus Atezolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Atezolizumab</arm_group_label>
    <arm_group_label>MOXR0916 plus Atezolizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of &lt;= 2&#xD;
&#xD;
          -  Life expectancy &gt;= 12 weeks&#xD;
&#xD;
          -  Histologically or cytologically confirmed locally advanced or metastatic urothelial&#xD;
             carcinoma (UC)&#xD;
&#xD;
          -  Availability of a representative formalin-fixed paraffin-embedded tumor specimen&#xD;
&#xD;
          -  No prior systemic therapy for inoperable locally advanced or metastatic UC&#xD;
&#xD;
          -  Ineligible for cisplatin-based chemotherapy as defined by any one of the following&#xD;
             criteria: Impaired renal function (glomerular filtration rate [GFR] &gt; 30 but &lt; 60&#xD;
             milliliter/minute [mL/min]); National Cancer Institute Common Terminology Criteria for&#xD;
             Adverse Events (NCI CTCAE) version (v) 4.0 Grade &gt;= 2 audiometric hearing loss (of 25&#xD;
             Decibel at two contiguous frequencies or more severe); NCI CTCAE v 4.0 Grade &gt;= 2&#xD;
             peripheral neuropathy; ECOG Performance Status of 2&#xD;
&#xD;
          -  Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1&#xD;
&#xD;
          -  Adequate hematologic and end-organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cardiovascular disease&#xD;
&#xD;
          -  Known clinically significant liver disease&#xD;
&#xD;
          -  Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3&#xD;
             weeks prior to initiation of study treatment&#xD;
&#xD;
          -  Prior treatment with CD137 or OX40 agonists, anti-cytotoxic T-lymphocyte-associated&#xD;
             protein (CTLA4), anti-programmed death-1 (PD-1), anti- programmed death-ligand 1&#xD;
             (PD-L1), anti-CD-27, anti- glucocorticoid-induced tumor necrosis factor receptor&#xD;
             (GITR) therapeutic antibody or pathway-targeting agents&#xD;
&#xD;
          -  Untreated central nervous system (CNS) metastases or active (progressing or requiring&#xD;
             corticosteroids for symptomatic control) CNS metastases&#xD;
&#xD;
          -  Any history of leptomeningeal disease&#xD;
&#xD;
          -  Malignancies other than UC within 5 years prior to Cycle 1, Day 1&#xD;
&#xD;
          -  History of autoimmune disease&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or&#xD;
             evidence of active pneumonitis on screening chest computed tomography scan&#xD;
&#xD;
          -  Active hepatitis B and C virus infection&#xD;
&#xD;
          -  Positive HIV test at screening&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Prior allogeneic stem cell or solid organ transplantation&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Oncology - HOPE Wilmot</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute of Baptist Health, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago; Hematology/Oncology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City - Menorah Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology, P.A.</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital; Cancer Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology, P.C.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center; Clinical Research Management Office</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onc/Hem Care Clin Trials LLC</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI Tennessee Oncology Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Inst.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Baylor Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates - Lake Wright Cancer Center</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GasthuisZusters Antwerpen</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - Oncology</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary NHS Trust</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and the London NHS Trust.</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Korea, Republic of</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>April 24, 2019</results_first_submitted>
  <results_first_submitted_qc>May 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2019</results_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2019</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>Carcinoma, Transitional Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</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>September 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03029832/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MOXR0916 Plus Atezolizumab</title>
          <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
        </group>
        <group group_id="P2">
          <title>Atezolizumab</title>
          <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Safety Follow-Up Completed</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death due to Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MOXR0916 Plus Atezolizumab</title>
          <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
        </group>
        <group group_id="B2">
          <title>Atezolizumab</title>
          <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="5"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of &gt;= 5 millimeter (mm) in the sum of diameters.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>Due to early termination, no formal analyses were performed for PFS.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of &gt;= 5 millimeter (mm) in the sum of diameters.</description>
          <population>Due to early termination, no formal analyses were performed for PFS.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>Due to early termination, no formal analyses were performed for OS.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.</description>
          <population>Due to early termination, no formal analyses were performed for OS.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response (OR) According to RECIST v1.1</title>
        <description>OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions &gt;= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>Due to early termination, no formal analyses were performed for OR.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response (OR) According to RECIST v1.1</title>
          <description>OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions &gt;= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
          <population>Due to early termination, no formal analyses were performed for OR.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (DOR) According to RECIST v1.1</title>
        <description>DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>Due to early termination, no formal analyses were performed for DOR.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Objective Response (DOR) According to RECIST v1.1</title>
          <description>DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
          <population>Due to early termination, no formal analyses were performed for DOR.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)</title>
        <description>The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot; with the participant's life.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>Due to early termination, no formal analyses were performed for time to pain progression, pain palliation and fatigue progression.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)</title>
          <description>The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot; with the participant's life.</description>
          <population>Due to early termination, no formal analyses were performed for time to pain progression, pain palliation and fatigue progression.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI</title>
        <description>The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot; with the participant's life.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>Due to early termination, no formal analyses were performed for percentage of participants reporting symptom interference with daily living at the time of progression according to the MDASI</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI</title>
          <description>The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot; with the participant's life.</description>
          <population>Due to early termination, no formal analyses were performed for percentage of participants reporting symptom interference with daily living at the time of progression according to the MDASI</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Event (AEs)</title>
        <description>An adverse event is any untoward medical occurrence, regardless of causal attribution.</description>
        <time_frame>Up to approximately 45 months</time_frame>
        <population>The safety population was defined as all participants who have received at least one dose of study medication. Data were collected but are not being summarized due to privacy concerns with the low number of patients analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Event (AEs)</title>
          <description>An adverse event is any untoward medical occurrence, regardless of causal attribution.</description>
          <population>The safety population was defined as all participants who have received at least one dose of study medication. Data were collected but are not being summarized due to privacy concerns with the low number of patients analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab</title>
        <description>AUC represents the body's exposure to an administered drug.</description>
        <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
        <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab</title>
          <description>AUC represents the body's exposure to an administered drug.</description>
          <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab</title>
        <description>Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.</description>
        <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
        <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab</title>
          <description>Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.</description>
          <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab</title>
        <description>Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.</description>
        <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
        <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab</title>
          <description>Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.</description>
          <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance of MOXR0916 and Atezolizumab</title>
        <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
        <time_frame>Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose</time_frame>
        <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance of MOXR0916 and Atezolizumab</title>
          <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
          <population>Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab</title>
        <description>ATAs may be produced by the body in response to an administered drug.</description>
        <time_frame>Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose</time_frame>
        <population>Due to early termination, no formal analyses were performed for percentage of participants with ATAs to MOXR0916 and Atezolizumab.</population>
        <group_list>
          <group group_id="O1">
            <title>MOXR0916 Plus Atezolizumab</title>
            <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab</title>
            <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab</title>
          <description>ATAs may be produced by the body in response to an administered drug.</description>
          <population>Due to early termination, no formal analyses were performed for percentage of participants with ATAs to MOXR0916 and Atezolizumab.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 45 months</time_frame>
      <desc>The safety population is defined as all patients who received at least one dose of the study medication. Data were collected for the adverse events but are not being summarized due to privacy concerns with low number of patients analyzed.</desc>
      <group_list>
        <group group_id="E1">
          <title>MOXR0916 Plus Atezolizumab</title>
          <description>Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
        </group>
        <group group_id="E2">
          <title>Atezolizumab</title>
          <description>Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.</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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT03029832
org study id: GO39590
secondary id: 2016-004165-58
nct id: NCT03029832
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to
      evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo
      and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma
      (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting
      and who are ineligible to receive cisplatin-based therapy.
The study design has been amended after the decision to prematurely stop patient accrual due
      to enrollment challenges. As only 5 participants were enrolled, the study blinding will not
      be maintained, and placebo infusions will not be administered. Patients assigned to the
      MOXR0916 arm may continue study treatment with the combination of atezolizumab and MOXR0916
      or with atezolizumab alone based on a discussion of benefit and risk with the treating
      investigator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: The study design has been amended in that the study blinding will not be maintained.
measure: Progression-Free Survival (PFS)
time frame: Up to approximately 45 months
description: PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters.
measure: Overall Survival (OS)
time frame: Up to approximately 45 months
description: Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.
measure: Objective Response (OR) According to RECIST v1.1
time frame: Up to approximately 45 months
description: OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
measure: Duration of Objective Response (DOR) According to RECIST v1.1
time frame: Up to approximately 45 months
description: DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
measure: Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)
time frame: Up to approximately 45 months
description: The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.
measure: Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI
time frame: Up to approximately 45 months
description: The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.
measure: Percentage of Participants With Adverse Event (AEs)
time frame: Up to approximately 45 months
description: An adverse event is any untoward medical occurrence, regardless of causal attribution.
measure: Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab
time frame: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
description: AUC represents the body's exposure to an administered drug.
measure: Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab
time frame: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
description: Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.
measure: Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab
time frame: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
description: Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.
measure: Clearance of MOXR0916 and Atezolizumab
time frame: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab
time frame: Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose
description: ATAs may be produced by the body in response to an administered drug.
arm group label: MOXR0916 plus Atezolizumab
arm group type: Experimental
arm group label: Atezolizumab
arm group type: Active Comparator
intervention type: Drug
intervention name: MOXR0916
description: MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
arm group label: MOXR0916 plus Atezolizumab
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
arm group label: Atezolizumab
arm group label: MOXR0916 plus Atezolizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Belgium
country: Canada
country: Korea, Republic of
country: United Kingdom
country: United States
country: France
country: Germany
country: Netherlands
country: Portugal
country: Switzerland
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Transitional Cell
mesh term: Atezolizumab
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 