<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/NCT03768570</url>
  </required_header>
  <id_info>
    <org_study_id>BL13</org_study_id>
    <secondary_id>2019-001310-42</secondary_id>
    <nct_id>NCT03768570</nct_id>
  </id_info>
  <brief_title>Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer</brief_title>
  <official_title>A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canadian Cancer Trials Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Cancer Trials Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out what effects durvalumab has on bladder cancer,&#xD;
      combined with treatment after completion of surgery, chemotherapy and radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is looking at whether a type of immunotherapy drug called durvalumab can be safely&#xD;
      administered after initial treatment received by a patient. Durvalumab has been tested in&#xD;
      many different types of cancers. Durvalumab works by allowing the immune system to detect&#xD;
      cancer and reactivate the immune response. This may help to slow down the growth of cancer or&#xD;
      may cause cancer cells to die. It is unclear if the addition of durvalumab is beneficial in&#xD;
      patients with bladder cancer who have completed surgery, radiotherapy and chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 25, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</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>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>defined as the time from the randomization to the time of the first event that is either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-muscle invasive bladder cancer recurrence rate</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loco-regional control rate between study arms at the 12 week visit</measure>
    <time_frame>5 years</time_frame>
    <description>defined as proportion of patients with a confirmed locoregional complete response at 3 months post randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patterns of disease recurrence between study arms</measure>
    <time_frame>5 years</time_frame>
    <description>The two treatment arms will be compared using the log-rank test stratified by ECOG Performance Status (0, 1 vs. 2+), Neoadjuvant chemotherapy (Yes/No), whole bladder versus partial bladder versus bladder plus regional lymph nodes RT field, and disease stage (T2 vs T3/4). A table will be presented summarizing the patterns of disease recurrence by treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare overall and bladder intact disease-free survival between study arms</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis-free survival between study arms</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and severity of adverse events between study arms</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life between treatment arms using Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>It consists of 39 questions, of which 12 are specific to bladder cancer. The questionnaire consists of 5 subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a final subscale focusing specifically on bladder cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness between study arms</measure>
    <time_frame>5 years</time_frame>
    <description>Estimate an incremental cost-effectiveness ratio reported as a difference in cost per Disease free survival-year gained of durvalumab vs. surveillance. analyses will focus on the incremental cost-effectiveness of durvalumab from a government payer perspective, over a disease-free survival time horizon by prospectively collecting economic and resource utilization information during the clinical trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-utility between study arms</measure>
    <time_frame>5 years</time_frame>
    <description>A partitioned-survival model (Markov model) will be developed using data obtained from the trial. Different parametric models will be evaluated to fit data from the trial in order to evaluate the incremental cost-utility over a 3-, 5- and 10-y horizon.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Surveillance</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Durvalumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months</description>
    <arm_group_label>Durvalumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic diagnosis of urothelial carcinoma of the bladder. Patients with mixed&#xD;
             histology (including small cell) and urothelial carcinoma are eligible. Patients with&#xD;
             pure small cell carcinoma will be excluded.&#xD;
&#xD;
          -  Stage T2-T4a N0M0 at time of diagnosis based on trans-urethral resection of bladder&#xD;
             tumour, imaging, and/or bimanual examination under anesthesia.&#xD;
&#xD;
          -  CT scan of the chest/abdomen/pelvis within 8 weeks from enrollment, showing no&#xD;
             evidence of metastatic disease.&#xD;
&#xD;
          -  Patients must be ≥ 18 years of age.&#xD;
&#xD;
          -  Patients must have a life expectancy greater than 6 months.&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of&#xD;
             0-2 and a body weight of &gt; 30kg.&#xD;
&#xD;
          -  Patients must have adequate hematologic reserve: Platelet count ≥ 75 x 10^9/L,&#xD;
             Absolute neutrophils ≥ 1.0 x 10^9/L. Anemia will be corrected to minimum hemoglobin of&#xD;
             90 g/L with red cell transfusions, if necessary.&#xD;
&#xD;
          -  Patients must have an estimated creatinine clearance (Cockcroft-Gault Equation) ≥ 30&#xD;
             ml/min.&#xD;
&#xD;
          -  Patients must have adequate liver function with a bilirubin ≤ 1.5 ULN (if confirmed&#xD;
             Gilbert's, eligible providing bilirubin ≤ 3 x UNL) and AST/ALT (SGOT/SGPT) &lt; 2.5 x the&#xD;
             upper normal limit.&#xD;
&#xD;
          -  All patients must have a tumour block from their primary tumour available and consent&#xD;
             to release the block/cores/cut slides for correlative analyses ( and the&#xD;
             centre/pathologist must have agreed to the submission of the specimen(s).&#xD;
&#xD;
          -  Patients have completed prior trimodality therapy (TMT) consisting of surgery,&#xD;
             chemotherapy and radiation therapy treatment prior to enrollment. Patient should start&#xD;
             treatment within 42 days after completion of TMT.&#xD;
&#xD;
          -  Patients must have undergone a transurethral resection prior to study enrollment.&#xD;
&#xD;
          -  Patient may have completed up to 4 cycles of cisplatin-based neo-adjuvant&#xD;
             chemotherapy. Adjuvant chemotherapy is not permitted. Patients will have received&#xD;
             cisplatin, given intravenously during the radiation therapy. OR Patients may have&#xD;
             received fluorouracil and mitomycin given intravenously once weekly or gemcitabine as&#xD;
             an alternative to cisplatin during radiotherapy.&#xD;
&#xD;
          -  The following are radiotherapy guidelines for patients treated on study. Patients will&#xD;
             be treated to radical treatment doses using IMRT, VMAT or 4 field conformal&#xD;
             techniques. Planning will be based on CT planning. IGRT is recommended during the&#xD;
             radiotherapy treatment. Recognizing differences in usual radiotherapy doses used in&#xD;
             the various participating countries and centres the following would be acceptable&#xD;
             doses in this study. The bladder CTV will include the whole empty bladder and any&#xD;
             extravesical extension. PTV expansion will be a minimum of 0.75 cm right, left and&#xD;
             inferiorly, 1.5 cm Anteriorly and superiorly and 1 cm posteriorly. These minimum&#xD;
             expansions are with Cone beam verification. For patients undergoing RT without&#xD;
             image-guided verification 1.5 cm expansion in all directions is recommended.&#xD;
             Acceptable doses for this study include:&#xD;
&#xD;
               -  Bladder only: 64-66 Gy in 32-33 fractions over 6.5 weeks; 50-55 Gy in 20&#xD;
                  fractions over 4 weeks&#xD;
&#xD;
               -  Pelvis and bladder: 45-46 Gy to pelvic nodes + 17-20 Gy bladder boost in 33-35&#xD;
                  fractions over 6.5-7 wks [Note: minimal nodal dose (if used) is 44 Gy in 32f or&#xD;
                  40 Gy in 20f]&#xD;
&#xD;
          -  Patients receiving concurrent bladder boost: pelvis dose 40 Gy and bladder dose 50 Gy&#xD;
             given in 20 fractions over 4 weeks. Adaptive radiotherapy techniques would be&#xD;
             acceptable.&#xD;
&#xD;
          -  Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life&#xD;
             questionnaires in either English, French or Spanish.&#xD;
&#xD;
          -  Patient consent must be appropriately obtained in accordance with applicable local and&#xD;
             regulatory requirements. Each patient must sign a consent form prior to enrollment in&#xD;
             the trial to document their willingness to participate.&#xD;
&#xD;
          -  Patients must be accessible for treatment and follow up. Patients registered on this&#xD;
             trial must be treated and followed at the participating centre. This implies there&#xD;
             must be reasonable geographical limits placed on patients being considered for this&#xD;
             trial.&#xD;
&#xD;
          -  In accordance with CCTG policy, protocol treatment is to begin within 2 working days&#xD;
             of patient enrollment.&#xD;
&#xD;
          -  Women/men of childbearing potential must have agreed to use a highly effective&#xD;
             contraceptive method during and for 3 months following treatment.&#xD;
&#xD;
          -  Patients with a prior or concurrent malignancy whose natural history or treatment does&#xD;
             not have the potential to interfere with the safety or efficacy assessment of the&#xD;
             investigational regimen are eligible for this trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing medical conditions precluding treatment.&#xD;
&#xD;
          -  Pregnancy or lactating mothers.&#xD;
&#xD;
          -  Received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1),&#xD;
             anti-PD-L1, including durvalumab anti-programmed cell death-ligand 2 (anti-PD-L2),&#xD;
             anti-CD137 (4-1BB ligand, a member of the Tumour Necrosis Factor Receptor [TNFR]&#xD;
             family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody&#xD;
             (including ipilimumab or any other antibody or drug specifically targeting T-cell&#xD;
             co-stimulation or checkpoint pathways).&#xD;
&#xD;
          -  Active or prior documented autoimmune or inflammatory disorders (including&#xD;
             inflammatory bowel disease (e.g. colitis or Crohn's disease: not due to radiation&#xD;
             reaction), diverticulitis with the exception of diverticulosis, celiac disease&#xD;
             (controlled by diet alone) or other serious gastrointestinal chronic conditions&#xD;
             associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or&#xD;
             Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis,&#xD;
             hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment.&#xD;
             The following are exceptions to this criterion:&#xD;
&#xD;
               -  Patients with alopecia;&#xD;
&#xD;
               -  Patients with Grave's disease, vitiligo or psoriasis not requiring systemic&#xD;
                  treatment (within the last 2 years);&#xD;
&#xD;
               -  Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on&#xD;
                  hormone replacement;&#xD;
&#xD;
               -  Any chronic skin condition that does not require systemic therapy.&#xD;
&#xD;
          -  Patients with active or uncontrolled intercurrent illness including, but not limited&#xD;
             to:&#xD;
&#xD;
               -  cardiac dysfunction (symptomatic congestive heart failure, uncontrolled&#xD;
                  hypertension, unstable angina pectoris, cardiac arrhythmia);&#xD;
&#xD;
               -  active peptic ulcer disease or gastritis;&#xD;
&#xD;
               -  active bleeding diatheses;&#xD;
&#xD;
               -  psychiatric illness/social situations that would limit compliance with study&#xD;
                  requirements or compromise the ability of the subject to give written informed&#xD;
                  consent;&#xD;
&#xD;
               -  known history of previous clinical diagnosis of tuberculosis;&#xD;
&#xD;
               -  known active human immunodeficiency virus infection (positive HIV 1/2&#xD;
                  antibodies). HIV-infected patients on effective anti-retroviral therapy with&#xD;
                  undetectable viral load within 6 months are eligible;&#xD;
&#xD;
               -  known active hepatitis B infection (positive HBV surface antigen (HBsAg).&#xD;
                  Patients with a past or resolved HBV infection (defined as presence of hepatitis&#xD;
                  B core antibody (anti-HBc) and absence of HBsAg) are eligible;&#xD;
&#xD;
               -  known active hepatitis C infection. Patients positive for hepatitis C (HCV)&#xD;
                  antibody are eligible only if polymerase chain reaction is negative for HCV RNA.&#xD;
&#xD;
          -  History of primary immunodeficiency, history of allogenic organ transplant that&#xD;
             requires therapeutic immunosuppression and the use of immunosuppressive agents within&#xD;
             28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated&#xD;
             toxicity from other immune therapy or grade ≥ 3 infusion reaction.&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 28 days of study entry,&#xD;
             with the exceptions of intranasal and inhaled corticosteroids or systemic chronic&#xD;
             corticosteroids at physiological doses, which are not to exceed 10 mg/day of&#xD;
             prednisone, or an equivalent corticosteroid. Corticosteroids used on study for&#xD;
             anti-emetic purpose are allowed. Corticosteroids as premedication for hypersensitivity&#xD;
             reactions (e.g. computed tomography [CT] scan premedication) are allowed.&#xD;
&#xD;
          -  Peripheral neuropathy ≥ grade 2 (CTCAE v5.0).&#xD;
&#xD;
          -  History of allergic or hypersensitivity reactions to any study drug or their&#xD;
             excipients.&#xD;
&#xD;
          -  Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec&#xD;
             in screening ECG measured using standard institutional method or history of familial&#xD;
             long QT syndrome.&#xD;
&#xD;
          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or&#xD;
             evidence of interstitial lung disease on baseline CT scan.&#xD;
&#xD;
          -  Any active disease condition which would render the protocol treatment dangerous or&#xD;
             impair the ability of the patient to receive protocol therapy.&#xD;
&#xD;
          -  Any condition (e.g. psychological, geographical, etc.) that does not permit compliance&#xD;
             with the protocol.&#xD;
&#xD;
          -  Live attenuated vaccination administered within 30 days prior to randomization.&#xD;
&#xD;
          -  Any prior carboplatin based therapy.&#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>Wassim Kassouf</last_name>
    <role>Study Chair</role>
    <affiliation>The Research Institute of the McGill University, Montreal QC Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA - Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Program</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stronach Regional Health Centre at Southlake</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Sciences North</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 5J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thunder Bay Regional Health Sciences Centre/</name>
      <address>
        <city>Thunder Bay</city>
        <state>Ontario</state>
        <zip>P7B 6V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Institute of the McGill University</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Centre</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Madrid Norte Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospitals NHS Trust</name>
      <address>
        <city>Cornwall</city>
        <state>England</state>
        <zip>TR1 3LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Lancashire</city>
        <state>England</state>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>VV6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust - Sutton</name>
      <address>
        <city>Surrey</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals City Hospital Campus</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03768570
org study id: BL13
secondary id: 2019-001310-42
nct id: NCT03768570
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out what effects durvalumab has on bladder cancer,
      combined with treatment after completion of surgery, chemotherapy and radiotherapy.
This study is looking at whether a type of immunotherapy drug called durvalumab can be safely
      administered after initial treatment received by a patient. Durvalumab has been tested in
      many different types of cancers. Durvalumab works by allowing the immune system to detect
      cancer and reactivate the immune response. This may help to slow down the growth of cancer or
      may cause cancer cells to die. It is unclear if the addition of durvalumab is beneficial in
      patients with bladder cancer who have completed surgery, radiotherapy and chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: 5 years
description: defined as the time from the randomization to the time of the first event that is either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause
measure: Non-muscle invasive bladder cancer recurrence rate
time frame: 5 years
measure: Loco-regional control rate between study arms at the 12 week visit
time frame: 5 years
description: defined as proportion of patients with a confirmed locoregional complete response at 3 months post randomization
measure: Patterns of disease recurrence between study arms
time frame: 5 years
description: The two treatment arms will be compared using the log-rank test stratified by ECOG Performance Status (0, 1 vs. 2+), Neoadjuvant chemotherapy (Yes/No), whole bladder versus partial bladder versus bladder plus regional lymph nodes RT field, and disease stage (T2 vs T3/4). A table will be presented summarizing the patterns of disease recurrence by treatment arms
measure: Compare overall and bladder intact disease-free survival between study arms
time frame: 5 years
measure: Metastasis-free survival between study arms
time frame: 5 years
measure: Number and severity of adverse events between study arms
time frame: 5 years
measure: Quality of Life between treatment arms using Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) questionnaire
time frame: 5 years
description: It consists of 39 questions, of which 12 are specific to bladder cancer. The questionnaire consists of 5 subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a final subscale focusing specifically on bladder cancer.
measure: Cost-effectiveness between study arms
time frame: 5 years
description: Estimate an incremental cost-effectiveness ratio reported as a difference in cost per Disease free survival-year gained of durvalumab vs. surveillance. analyses will focus on the incremental cost-effectiveness of durvalumab from a government payer perspective, over a disease-free survival time horizon by prospectively collecting economic and resource utilization information during the clinical trial.
measure: Cost-utility between study arms
time frame: 5 years
description: A partitioned-survival model (Markov model) will be developed using data obtained from the trial. Different parametric models will be evaluated to fit data from the trial in order to evaluate the incremental cost-utility over a 3-, 5- and 10-y horizon.
arm group label: Surveillance
arm group type: No Intervention
arm group label: Durvalumab
arm group type: Active Comparator
intervention type: Drug
intervention name: Durvalumab
description: 1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months
arm group label: Durvalumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wassim Kassouf
role: Study Chair
affiliation: The Research Institute of the McGill University, Montreal QC Canada
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country: Canada
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Durvalumab
sharing ipd: No