<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/NCT03022825</url>
  </required_header>
  <id_info>
    <org_study_id>CA-ALT-803-01-16</org_study_id>
    <nct_id>NCT03022825</nct_id>
  </id_info>
  <brief_title>QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer</brief_title>
  <official_title>QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImmunityBio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ImmunityBio, 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/III, open-label, single-arm, multicenter study of intravesical BCG plus&#xD;
      N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder&#xD;
      cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the&#xD;
      bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction&#xD;
      treatment period). After the first disease assessment, eligible patients will receive either&#xD;
      a 3-week maintenance course or a 6-week re-induction course (second treatment period) at&#xD;
      Month 3. Eligible patients will continue to receive maintenance treatment in the third&#xD;
      treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive&#xD;
      maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study&#xD;
      duration is 60 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Complete Response</measure>
    <time_frame>60 Months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease-Free Rate</measure>
    <time_frame>12 Months</time_frame>
    <description>Cohort B: Assess disease-free rate at 12 months since first study treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>60 months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess duration of complete response Cohort B: Assess disease-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>6 months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess complete response rate at 6 months. Cohort B: Assess disease-free rate at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>9 months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess complete response rate at 9 months. Cohort B: Assess disease-free rate at 9 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>12 months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess complete response rate at 12 months. Cohort B: Assess disease-free rate at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>18 months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess complete response rate at 18 months. Cohort B: Assess disease-free rate at 18 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>24 months</time_frame>
    <description>Cohort A &amp; Cohort C: Assess complete response rate at 24 months. Cohort B: Assess disease-free rate at 24 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response</measure>
    <time_frame>60 months</time_frame>
    <description>Assess complete response rate at any time of CIS patients per central pathology review Duration of complete response (all recurrent bladder cancer, including low grade Ta disease)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>BCG+N-803</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-803 and BCG</intervention_name>
    <description>BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.</description>
    <arm_group_label>BCG+N-803</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-803</intervention_name>
    <description>N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.</description>
    <arm_group_label>BCG+N-803</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients 18 years of age or older&#xD;
&#xD;
          -  Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell&#xD;
             carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell&#xD;
             histology is predominant histology).&#xD;
&#xD;
          -  Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1&#xD;
             disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1&#xD;
             disease.&#xD;
&#xD;
          -  Absence of resectable disease after transurethral resection (TURBT) procedures&#xD;
             (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo&#xD;
             repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did&#xD;
             not include muscularis propria). Patients with high-grade Ta and/or T1 disease should&#xD;
             have complete resection before study treatment.&#xD;
&#xD;
          -  BCG-unresponsive disease as defined as: (a) Persistent or recurrent CIS (+/- recurrent&#xD;
             Ta/T1 disease) within 12 months of receiving adequate BCG (at least five of six doses&#xD;
             doses of an initial induction course plus either at least two of three doses of&#xD;
             maintenance therapy or at least two of six doses of a second induction course); or (b)&#xD;
             Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at&#xD;
             least five of six doses of an initial induction course plus either at least two of&#xD;
             three doses of maintenance therapy or at least two of six doses of a second induction&#xD;
             course); or (c) T1 high-grade disease at the first evaluation following an induction&#xD;
             BCG course alone (at least five of six doses of an initial induction course).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
&#xD;
          -  Voluntary written informed consent and HIPAA authorization and agree to comply with&#xD;
             all protocol-specified procedures and follow-up evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrence of BCG unresponsive Ta/T1 disease (without presence of CIS) &gt; 6 months&#xD;
             after last BCG instillation or BCG unresponsive CIS &gt; 12 months after last BCG&#xD;
             instillation.&#xD;
&#xD;
          -  Life expectancy &lt;2 years&#xD;
&#xD;
          -  Any of the following clinical laboratory values at the time of enrollment: (1)&#xD;
             Absolute neutrophil count (ANC) &lt;800/µL or (2) Platelets &lt; 50,000/µL&#xD;
&#xD;
          -  Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or&#xD;
             ALT) &gt;2 times upper limit of normal (ULN)&#xD;
&#xD;
          -  Renal insufficiency as indicated by a creatinine level &gt;3 times ULN&#xD;
&#xD;
          -  History of or evidence of muscle-invasive, locally advanced, metastatic and/or&#xD;
             extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer&#xD;
             within the past 5 years that is progressing or requires active treatment. Exceptions&#xD;
             are adequately treated basal cell or squamous cell skin cancer that has undergone&#xD;
             potentially curative therapy or in situ cervical cancer; and adequately treated stage&#xD;
             I or II cancer or stable prostate cancer from which the patient is currently in&#xD;
             complete remission, and is under active surveillance or hormone control.&#xD;
&#xD;
          -  Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class&#xD;
             III or IV heart failure or other clinical signs of severe cardiac dysfunction&#xD;
&#xD;
          -  Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to&#xD;
             study entry&#xD;
&#xD;
          -  History or evidence of uncontrollable central nervous system (CNS) disease&#xD;
&#xD;
          -  Active systemic infection requiring parenteral antibiotic therapy. All prior&#xD;
             infections must have resolved following optimal therapy&#xD;
&#xD;
          -  Concurrent febrile illness, active urinary tract infection, active tuberculosis, a&#xD;
             history of hypotension or anaphylactic reactions&#xD;
&#xD;
          -  Ongoing chronic systemic steroid therapy required (&gt;10 mg oral prednisone daily or&#xD;
             equivalent)&#xD;
&#xD;
          -  Women who are pregnant or nursing. Female patients of childbearing potential must have&#xD;
             a negative pregnancy test and must adhere to using a medically acceptable method of&#xD;
             birth control prior to screening and agree to continue its use during the study and&#xD;
             for 30 days after the last dose of study drug, or be surgically sterilized (e.g.,&#xD;
             hysterectomy or tubal ligation). Women of childbearing potential are defined as any&#xD;
             female who has experienced menarche and who is NOT permanently sterile or&#xD;
             postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses&#xD;
             without an alternative medical cause. Males must agree to use barrier methods of birth&#xD;
             control while on study and for 90 days post last dose of study drug.&#xD;
&#xD;
          -  Patients currently receiving investigational or commercial anti-cancer agents or&#xD;
             anti-cancer therapies other than BCG, ALT-803 and supportive care therapies for active&#xD;
             disease.&#xD;
&#xD;
          -  Concurrent use of other investigational agents (not including FDA authorized drugs for&#xD;
             the prevention and treatment of COVID-19).&#xD;
&#xD;
          -  Other illness or condition, including laboratory abnormalities, which in the opinion&#xD;
             of the Investigator would exclude the patient from participating in this study. This&#xD;
             includes, but is not limited to, serious medical conditions or psychiatric illness&#xD;
             likely to interfere with participation in the study.&#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>Karim Chamie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paula Bradshaw</last_name>
    <phone>844-413-8500</phone>
    <email>paula.bradshaw@immunitybio.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alaska Clinical Research Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Arkansas Urology</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>West Coast Urology</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>UCLA Department of Urology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ankush Sachdeva</last_name>
      <phone>310-794-3421</phone>
      <email>ASachdeva@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Karim Chamie, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hoag Memorial Hospital</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leila Andres</last_name>
      <phone>949-764-8092</phone>
      <email>leila.andres@hoag.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey Bassett, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Skyline Urology</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Skyline Urology</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Urology Associates, PC</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Eastern Connecticut Hematology and Oncology Associates</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shashana Fielder, MPH</last_name>
      <phone>305-243-2177</phone>
      <email>sxf780@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Mark L Gonzalgo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Florida</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dwight D. Eisenhower Army Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Hawaii Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsay Szakaly</last_name>
      <email>lszakaly@med.umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Dani Kasprzynski</last_name>
      <email>kasprzyd@med.umich.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Samuel D Kaffenberger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Adult &amp; Pediatric Urology</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Accument Rx</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Insitute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital Department of Urology</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Leanez</last_name>
      <phone>917-409-3919</phone>
      <email>lleanez@manhattanmedicalresearch.com</email>
    </contact>
    <investigator>
      <last_name>Jed Kaminetsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group of the Hudson Valley</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Gray, RN</last_name>
      <phone>845-437-3804</phone>
      <email>Lgray@premiermedicalhv.com</email>
    </contact>
    <investigator>
      <last_name>Evan Goldfischer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Associated Urologists of North Carolina</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kiplyne Moffett</last_name>
      <phone>919-758-7386</phone>
      <email>kmoffett@auncurology.com</email>
    </contact>
    <investigator>
      <last_name>Mark W Jalkut, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia Dahlgren</last_name>
      <phone>267-343-6558</phone>
      <email>Olivia.Dahlgren@jefferson.edu</email>
    </contact>
    <investigator>
      <last_name>Edouard Trabulsi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Urology</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ceon Clark</last_name>
      <phone>804-288-2785</phone>
      <email>clclark@uro.com</email>
    </contact>
    <investigator>
      <last_name>Eugene Kramolowsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BCG</keyword>
  <keyword>bladder cancer</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>interleukin-15</keyword>
  <keyword>intravesical</keyword>
  <keyword>non-muscle invasive</keyword>
  <keyword>NMIBC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022825
org study id: CA-ALT-803-01-16
nct id: NCT03022825
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus
      N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder
      cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the
      bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction
      treatment period). After the first disease assessment, eligible patients will receive either
      a 3-week maintenance course or a 6-week re-induction course (second treatment period) at
      Month 3. Eligible patients will continue to receive maintenance treatment in the third
      treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive
      maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study
      duration is 60 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Response
time frame: 60 Months
description: Cohort A & Cohort C: Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
measure: Disease-Free Rate
time frame: 12 Months
description: Cohort B: Assess disease-free rate at 12 months since first study treatment
measure: Response
time frame: 60 months
description: Cohort A & Cohort C: Assess duration of complete response Cohort B: Assess disease-free survival
measure: Response
time frame: 6 months
description: Cohort A & Cohort C: Assess complete response rate at 6 months. Cohort B: Assess disease-free rate at 6 months
measure: Response
time frame: 9 months
description: Cohort A & Cohort C: Assess complete response rate at 9 months. Cohort B: Assess disease-free rate at 9 months
measure: Response
time frame: 12 months
description: Cohort A & Cohort C: Assess complete response rate at 12 months. Cohort B: Assess disease-free rate at 12 months
measure: Response
time frame: 18 months
description: Cohort A & Cohort C: Assess complete response rate at 18 months. Cohort B: Assess disease-free rate at 18 months
measure: Response
time frame: 24 months
description: Cohort A & Cohort C: Assess complete response rate at 24 months. Cohort B: Assess disease-free rate at 24 months
measure: Complete Response
time frame: 60 months
description: Assess complete response rate at any time of CIS patients per central pathology review Duration of complete response (all recurrent bladder cancer, including low grade Ta disease)
arm group label: BCG+N-803
arm group type: Experimental
intervention type: Drug
intervention name: N-803 and BCG
description: BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.
arm group label: BCG+N-803
intervention type: Drug
intervention name: N-803
description: N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.
arm group label: BCG+N-803
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karim Chamie, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Paula Bradshaw
phone: 844-413-8500
email: paula.bradshaw@immunitybio.com
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
sharing ipd: No