xml: <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/NCT06018116</url>
    </required_header>
    <id_info>
      <org_study_id>MP-20-2024-6963</org_study_id>
      <nct_id>NCT06018116</nct_id>
    </id_info>
    <brief_title>A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.</brief_title>
    <acronym>CANUCK-01</acronym>
    <official_title>A Canadian Phase II, Placebo-controlled Randomized Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CHU de Quebec-Universite Laval</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cancer Research Society</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>CHU de Quebec-Universite Laval</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase II, multi-center, placebo-controlled randomized controlled trial of standard&#xD;
        of care (SOC) avelumab versus SOC avelumab with bicalutamide for patients with metastatic or&#xD;
        locally advanced urothelial carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Urothelial carcinoma (UC) is the second most common urological cancer after prostate cancer.&#xD;
        Non-muscle invasive bladder cancer (NMIBC) is the most common form (~75%). Muscle-invasive&#xD;
        bladder cancer (MIBC) is found at presentation in ~25% of patients, with 10-20% of NMIBC&#xD;
        eventually becoming MIBC. Risk groups for NMIBC are based on number of tumours, stage and&#xD;
        size. Almost half of patients with MIBC eventually progress to metastatic disease.&#xD;
  &#xD;
        Treatments for metastatic urothelial carcinoma (mUC) have evolved rapidly over the last&#xD;
        several years. Pembrolizumab demonstrated benefit as second line therapy for locally advanced&#xD;
        and metastatic UC. Subsequently, the landmark Phase III randomized JAVELIN trial showed that&#xD;
        the addition of avelumab as maintenance therapy following a response to chemotherapy for mUC&#xD;
        significantly prolonged overall survival relative to best supportive care (hazard ratio (HR)&#xD;
        = 0.69; 95% confidence interval (CI), 0.56-0.86; P = 0.001). Overall survival and&#xD;
        progression-free survival were 21.4 months (18.9 to 26.1) and 5.5 (4.2 to 7.2) months,&#xD;
        respectively. This trial established avelumab as the SOC treatment and initial immunotherapy&#xD;
        for mUC following chemotherapy.&#xD;
  &#xD;
        The investigators have selected a double-blind placebo-controlled randomized study design to&#xD;
        be able to assess the pragmatic endpoint of investigator-assessed clinical progression.&#xD;
        Randomization will assign patients 2:1 to bicalutamide 150mg daily plus SOC avelumab or&#xD;
        placebo plus SOC avelumab. Patients will be followed every 3 months after avelumab treatment&#xD;
        has started and until progression.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of bladder tumor recurrence</measure>
      <time_frame>30 months</time_frame>
      <description>The primary outcome will be to the time to investigator-assessed progression on avelumab therapy.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">69</enrollment>
    <condition>Metastatic Urothelial Carcinoma</condition>
    <arm_group>
      <arm_group_label>Bicalutamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>standard of care (SOC) avelumab with 150mg daily oral bicalutamide</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>standard of care (SOC) avelumab with daily oral placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bicalutamide 150 mg</intervention_name>
      <description>nonsteroidal antiandrogen</description>
      <arm_group_label>Bicalutamide</arm_group_label>
      <other_name>standard of care avelumab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>placebo</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>standard of care avelumab</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 or greater and able to provide informed consent for the trial;&#xD;
  &#xD;
            2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening;&#xD;
  &#xD;
            3. Patients with histologically confirmed urothelial carcinoma;&#xD;
  &#xD;
            4. Patients is a candidate for a course of maintenance avelumab treatment for metastatic&#xD;
               or locally advanced urothelial carcinoma;&#xD;
  &#xD;
            5. Male patients with partners of child-bearing potential must agree to 2 acceptable&#xD;
               forms of birth control and be continued for at least 130 days after study drug is&#xD;
               discontinued.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase&#xD;
               or bilirubin are greater than twice the upper limit of normal will be ineligible.&#xD;
  &#xD;
            2. Patients with neutrophils (&lt; 1,000/μL) will be ineligible.&#xD;
  &#xD;
            3. Patients on androgen replacement therapy, or those with prostate cancer or other&#xD;
               diseases currently treated with systemic hormonal therapy will be ineligible for study&#xD;
               enrollment. Patients receiving 5-alpha reductase inhibitors will not be excluded.&#xD;
  &#xD;
            4. Patients who have a concurrent malignancy other than UC within the past years for&#xD;
               which treatment is planned within the next 6 months.&#xD;
  &#xD;
            5. Patients taking an investigational drug within 2 weeks of enrollment into this study.&#xD;
  &#xD;
            6. Patients receiving or planning to receive coumadin therapy.&#xD;
  &#xD;
            7. Female patients with childbearing potential are excluded due to known teratogenic&#xD;
               effects of bicalutamide.&#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>Paul Toren, MD, PhD, FRCSC</last_name>
      <role>Study Chair</role>
      <affiliation>CHU de Québec - Université Laval</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paul Toren, MD, PhD, FRCSC</last_name>
      <phone>418-525-4444</phone>
      <phone_ext>17064</phone_ext>
      <email>paul.toren@crchudequebec.ulaval.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU de Québec - Université Laval</name>
        <address>
          <city>Québec</city>
          <zip>G1G 5X1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Paul Toren, MD, PhD</last_name>
        <phone>418-525-4444</phone>
        <phone_ext>17064</phone_ext>
        <email>paul.toren@crchudequebec.ulaval.ca</email>
      </contact>
      <contact_backup>
        <last_name>Catherine Gérard, PhD</last_name>
        <phone>418-525-4444</phone>
        <phone_ext>67704</phone_ext>
        <email>catherine.gerard@crchudequebec.ulaval.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bicalutamide</keyword>
    <keyword>avelumab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Transitional Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Avelumab</mesh_term>
      <mesh_term>Bicalutamide</mesh_term>
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018116
  org study id: MP-20-2024-6963
  nct id: NCT06018116
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This is a Phase II, multi-center, placebo-controlled randomized controlled trial of standard
        of care (SOC) avelumab versus SOC avelumab with bicalutamide for patients with metastatic or
        locally advanced urothelial carcinoma.
  Urothelial carcinoma (UC) is the second most common urological cancer after prostate cancer.
        Non-muscle invasive bladder cancer (NMIBC) is the most common form (~75%). Muscle-invasive
        bladder cancer (MIBC) is found at presentation in ~25% of patients, with 10-20% of NMIBC
        eventually becoming MIBC. Risk groups for NMIBC are based on number of tumours, stage and
        size. Almost half of patients with MIBC eventually progress to metastatic disease.
  
        Treatments for metastatic urothelial carcinoma (mUC) have evolved rapidly over the last
        several years. Pembrolizumab demonstrated benefit as second line therapy for locally advanced
        and metastatic UC. Subsequently, the landmark Phase III randomized JAVELIN trial showed that
        the addition of avelumab as maintenance therapy following a response to chemotherapy for mUC
        significantly prolonged overall survival relative to best supportive care (hazard ratio (HR)
        = 0.69; 95% confidence interval (CI), 0.56-0.86; P = 0.001). Overall survival and
        progression-free survival were 21.4 months (18.9 to 26.1) and 5.5 (4.2 to 7.2) months,
        respectively. This trial established avelumab as the SOC treatment and initial immunotherapy
        for mUC following chemotherapy.
  
        The investigators have selected a double-blind placebo-controlled randomized study design to
        be able to assess the pragmatic endpoint of investigator-assessed clinical progression.
        Randomization will assign patients 2:1 to bicalutamide 150mg daily plus SOC avelumab or
        placebo plus SOC avelumab. Patients will be followed every 3 months after avelumab treatment
        has started and until progression.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Rate of bladder tumor recurrence
  time frame: 30 months
  description: The primary outcome will be to the time to investigator-assessed progression on avelumab therapy.
  arm group label: Bicalutamide
  arm group type: Experimental
  description: standard of care (SOC) avelumab with 150mg daily oral bicalutamide
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: standard of care (SOC) avelumab with daily oral placebo
  intervention type: Drug
  intervention name: Bicalutamide 150 mg
  description: nonsteroidal antiandrogen
  arm group label: Bicalutamide
  other name: standard of care avelumab
  intervention type: Drug
  intervention name: Placebo
  description: placebo
  arm group label: Placebo
  other name: standard of care avelumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Paul Toren, MD, PhD, FRCSC
  role: Study Chair
  affiliation: CHU de Québec - Université Laval
  last name: Paul Toren, MD, PhD, FRCSC
  phone: 418-525-4444
  phone ext: 17064
  email: paul.toren@crchudequebec.ulaval.ca
  facility: 
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Carcinoma, Transitional Cell
  mesh term: Avelumab
  mesh term: Bicalutamide
  mesh term: Antibodies, Monoclonal
  sharing ipd: No