<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/NCT03799835</url>
  </required_header>
  <id_info>
    <org_study_id>UC-0160/1717</org_study_id>
    <secondary_id>2017-004512-19</secondary_id>
    <nct_id>NCT03799835</nct_id>
  </id_info>
  <brief_title>Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients</brief_title>
  <acronym>ALBAN</acronym>
  <official_title>An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UNICANCER</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, randomized, multicentric study in patients with high-risk non-muscle&#xD;
      invasive bladder cancer who had never received BCG for this disease.&#xD;
&#xD;
      The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free&#xD;
      survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ALBAN study will randomize 516 patients in 45 centers in Europe (France, Belgium and Spain),&#xD;
      according to a ratio 1:1 in the following arms of treatment:&#xD;
&#xD;
        -  Arm A (control arm): BCG only&#xD;
&#xD;
        -  Arm B (experimental arm): BCG+ atezolizumab&#xD;
&#xD;
      The are two factors of stratifications (center and CIS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <phase>Phase 3</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>Recurrence-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From randomization to the date of progression, assessed up to 5 years</time_frame>
    <description>Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>From randomization to the date of death, assessed up to 5 years</time_frame>
    <description>Disease-specific survival defined as the time from randomization to the date of death from bladder cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From randomization to the date of death, assessed up to 5 years</time_frame>
    <description>Overall Survival defined as the time from randomization to the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease worsening in each arm</measure>
    <time_frame>From randomization to the date of death, assessed up to 5 years</time_frame>
    <description>Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response in each arm</measure>
    <time_frame>6 weeks and 2 years after randomization</time_frame>
    <description>Complete response is assessed by cystoscopy and cytology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response among patients with CIS</measure>
    <time_frame>6 weeks and 2 years after randomization</time_frame>
    <description>Complete response is assessed by cystoscopy and cytology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0</measure>
    <time_frame>Throughout study completion, assessed up to 5 years</time_frame>
    <description>The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC)</measure>
    <time_frame>At randomization, every 12 weeks for years 1 and 2 after randomization, then every 24 weeks for years 3 to 5 after randomization</time_frame>
    <description>This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.&#xD;
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.&#xD;
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">516</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A : control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BCG therapy only&#xD;
BCG therapy will be administered in two phases:&#xD;
induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)&#xD;
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCG therapy + administration of atezolizumab&#xD;
BCG therapy will be administered in two phases:&#xD;
induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)&#xD;
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).&#xD;
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCG</intervention_name>
    <description>Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®</description>
    <arm_group_label>Arm A : control arm</arm_group_label>
    <arm_group_label>Arm B: experimental arm</arm_group_label>
    <other_name>Bacillus Calmette Guerin (BCG) Medac®</other_name>
    <other_name>OncoTice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>IV perfusion</description>
    <arm_group_label>Arm B: experimental arm</arm_group_label>
    <other_name>MPDL3280A</other_name>
    <other_name>Tecentriq®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent form after the last endoscopic surgery (TURBT)&#xD;
&#xD;
          2. Adult man and women ( age ≥18 years)&#xD;
&#xD;
          3. Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed&#xD;
             histology tumors allowed if urothelial carcinoma histology is predominant) defined on&#xD;
             the TURBT as any of the following :&#xD;
&#xD;
               -  T1 tumor and/or&#xD;
&#xD;
               -  High grade (WHO 2004) and/or&#xD;
&#xD;
               -  Grade 3 (WHO1973) and/or&#xD;
&#xD;
               -  Carcinoma in situ (CIS)&#xD;
&#xD;
          4. Tumor tissue available from the surgery for central confirmation of the diagnosis and&#xD;
             analysis the expression of PD-L1&#xD;
&#xD;
          5. At least one additional (second) resection of the primary tumor has been performed in&#xD;
             any of the following cases [without upstaging towards Muscle Invasive Bladder Cancer&#xD;
             (EAU guidelines, 2017)] :&#xD;
&#xD;
               -  T1 tumors at physician's discretion,&#xD;
&#xD;
               -  incomplete initial TURB,&#xD;
&#xD;
               -  no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only&#xD;
                  was found)&#xD;
&#xD;
          6. Absence of metastasis in pelvis, abdomen, or chest, as confirmed by a negative&#xD;
             baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan no more&#xD;
             than 90 days prior to the first study treatment&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2&#xD;
&#xD;
          8. Life expectancy ≥12 weeks&#xD;
&#xD;
          9. Systolic blood pressure (BP) &lt;160 mmHg and diastolic BP &lt;95 mmHg, as documented within&#xD;
             7 days prior to the first study treatment (hypertension allowed provided it is&#xD;
             controlled)&#xD;
&#xD;
         10. Adequate hematologic and end-organ function, as defined by the following laboratory&#xD;
             results obtained within 7 days prior to the first study treatment:&#xD;
&#xD;
               -  absolute neutrophil count (ANC) ≥1500 cells/μL&#xD;
&#xD;
               -  white blood cell (WBC) counts &gt;2500/μL&#xD;
&#xD;
               -  Lymphocyte count ≥300/μL&#xD;
&#xD;
               -  Platelet count ≥100,000/μL&#xD;
&#xD;
               -  Hemoglobin ≥9.0 g/dL&#xD;
&#xD;
               -  aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline&#xD;
                  phosphatase ≤2.5 × the upper limit of normal (ULN)&#xD;
&#xD;
               -  Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum&#xD;
                  bilirubin level ≤3 × ULN may be enrolled.&#xD;
&#xD;
               -  Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or&#xD;
                  international normalized ratio (INR) &lt;1.7 × ULN&#xD;
&#xD;
               -  Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)&#xD;
&#xD;
         11. For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraceptive methods that result in a failure rate&#xD;
             of &lt;1% per year during the treatment period and for at least 5 months after the last&#xD;
             dose of atezolizumab&#xD;
&#xD;
         12. Patients affiliated to the social security system&#xD;
&#xD;
         13. Patient is willing and able to comply with the protocol for the duration of the trial&#xD;
             including undergoing treatment and scheduled visits, and examinations including&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient having received previous BCG therapy for bladder cancer&#xD;
&#xD;
          2. Any approved anti-cancer therapy, including systemic chemotherapy, or hormonal therapy&#xD;
             within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or&#xD;
             oral contraceptives are allowed&#xD;
&#xD;
          3. Treatment with any other investigational agent or participation in another clinical&#xD;
             trial with therapeutic intent within 28 days or five half-lives of the drug, whichever&#xD;
             is longer, prior to day 1 of study treatment&#xD;
&#xD;
          4. Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of&#xD;
             treatment except the following:&#xD;
&#xD;
               -  Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason&#xD;
                  score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated&#xD;
                  with curative intent (radiotherapy and/or prostatectomy) and without&#xD;
                  prostate-specific antigen (PSA) recurrence are eligible.&#xD;
&#xD;
               -  Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7&#xD;
                  and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are&#xD;
                  eligible.&#xD;
&#xD;
               -  Patients with malignancies of a negligible risk of metastasis or death (e.g.,&#xD;
                  risk of metastasis or death &lt;5% at 5 years) are eligible provided they meet all&#xD;
                  of the following criteria: malignancy treated with expected curative intent (such&#xD;
                  as adequately treated carcinoma in situ of the cervix, basal or squamous cell&#xD;
                  skin cancer, or ductal carcinoma in situ treated surgically with curative intent)&#xD;
                  and no evidence of recurrence or metastasis by follow-up imaging and any&#xD;
                  disease-specific tumor markers.&#xD;
&#xD;
          5. Pregnancy or breastfeeding&#xD;
&#xD;
          6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          7. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells&#xD;
             or any component of the atezolizumab formulation&#xD;
&#xD;
          8. History of autoimmune disease or history of immunosuppression, or conditions&#xD;
             associated with congenital or acquired immune deficiency , including, but not limited&#xD;
             to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,&#xD;
             rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with&#xD;
             antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome,&#xD;
             Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see&#xD;
             Appendix 6 for a more comprehensive list of autoimmune diseases)&#xD;
&#xD;
               -  Patients with a history of autoimmune-related hypothyroidism/hyperthyroidism on a&#xD;
                  stable dose of thyroid replacement hormone may be eligible for this study.&#xD;
&#xD;
               -  Patients with controlled Type I diabetes mellitus on a stable dose of insulin&#xD;
                  regimen may be eligible for this study.&#xD;
&#xD;
               -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,&#xD;
                  bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or&#xD;
                  evidence of active pneumonitis on screening chest CT scan may be eligible.&#xD;
&#xD;
               -  History of radiation pneumonitis in the radiation field (fibrosis) is permitted.&#xD;
&#xD;
          9. Serum albumin &lt;2.5 g/dL&#xD;
&#xD;
         10. Known HIV infection&#xD;
&#xD;
         11. Patients with active hepatitis B virus (HBV; chronic or acute; defined as having a&#xD;
             positive hepatitis B surface antigen (HBsAg) test prior the randomisation) or&#xD;
             hepatitis C.&#xD;
&#xD;
               -  Patients with past HBV infection or resolved HBV infection (defined as the&#xD;
                  presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are&#xD;
                  eligible. HBV DNA must be obtained in these patients prior to randomisation.&#xD;
&#xD;
               -  Patients positive for hepatitis C virus (HCV) antibody are eligible only if&#xD;
                  polymerase chain reaction is negative for HCV RNA.&#xD;
&#xD;
         12. Known active tuberculosis&#xD;
&#xD;
         13. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to&#xD;
             hospitalization for complications of infection, bacteremia, or severe pneumonia&#xD;
&#xD;
         14. Signs or symptoms of urinary infection and/or other signs and symptoms &gt; grade 1 (NCI&#xD;
             CTCAE v5.0) within 2 weeks prior to Cycle 1, Day 1&#xD;
&#xD;
               -  Patients receiving therapeutic oral or IV antibiotics within 2 weeks prior to&#xD;
                  Cycle 1, Day 1 are not eligible&#xD;
&#xD;
               -  Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary&#xD;
                  tract infection or to prevent chronic obstructive pulmonary disease exacerbation)&#xD;
                  are eligible.&#xD;
&#xD;
         15. Significant cardiovascular disease, such as New York Heart Association cardiac disease&#xD;
             (Class II or greater), myocardial infarction within the previous 3 months before&#xD;
             Cycle1, Day 1, unstable arrhythmias, or unstable angina.&#xD;
&#xD;
             - Patients with known coronary artery disease, congestive heart failure not meeting&#xD;
             the above criteria, or left ventricular ejection fraction &lt;50% must be on a stable&#xD;
             medical regimen that is optimized in the opinion of the treating physician, in&#xD;
             consultation with a cardiologist if appropriate.&#xD;
&#xD;
         16. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day&#xD;
             1 or anticipation of need for a major surgical procedure during the course of the&#xD;
             study&#xD;
&#xD;
         17. Prior allogeneic stem cell or solid organ transplant&#xD;
&#xD;
         18. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or&#xD;
             anticipation if such a live, attenuated vaccine will be required during the study&#xD;
&#xD;
             - Influenza vaccination should be given during influenza season only (approximately&#xD;
             October through May in the Northern Hemisphere and approximately April through&#xD;
             September in the Southern Hemisphere). Patients must agree not to receive live,&#xD;
             attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1,&#xD;
             at randomization, during treatment or within 5 months following the last dose of&#xD;
             atezolizumab (for patients randomized to atezolizumab).&#xD;
&#xD;
         19. Any other disease, metabolic dysfunction, physical examination finding, or clinical&#xD;
             laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
             contraindicates the use of an investigational drug or that may affect the&#xD;
             interpretation of the results or render the patient at high risk from treatment&#xD;
             complications&#xD;
&#xD;
         20. Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including&#xD;
             anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies&#xD;
&#xD;
         21. Treatment with systemic immunostimulatory agents (including but not limited to&#xD;
             interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug,&#xD;
             whichever is shorter, prior to Cycle 1, Day 1&#xD;
&#xD;
         22. Treatment with systemic corticosteroids or other systemic immunosuppressive&#xD;
             medications (including but not limited to prednisone, dexamethasone, cyclophosphamide,&#xD;
             azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF)&#xD;
             agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for&#xD;
             systemic immunosuppressive medications during the trial&#xD;
&#xD;
               -  Patients who have received acute, low-dose, systemic immunosuppressant&#xD;
                  medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses&#xD;
                  for contrast allergy) may be enrolled in the study.&#xD;
&#xD;
               -  The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for&#xD;
                  chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g.,&#xD;
                  fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for&#xD;
                  patients with orthostatic hypotension or adrenocortical insufficiency is allowed.&#xD;
&#xD;
         23. Person deprived of their liberty or under protective custody or guardianship&#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>Morgan Roupret, MD-PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Pitié-Salpétrière</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yohann Loriot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Soazig Nénan-Le Ficher</last_name>
    <phone>+33185343113</phone>
    <email>s-nenan@unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maggy Chausson</last_name>
    <phone>+33185343112</phone>
    <phone_ext>+33185343112</phone_ext>
    <email>m-chausson@unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Groupe Jolimont - Hôpital de Jolimont</name>
      <address>
        <city>Haine Saint Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ Delta - Campus Rumbeke</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lieven Goeman, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Souhil Lebdai, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grégoire Robert, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Marine Gross-Goupil, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital G. Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Guy, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Clinique Claude Bernard</name>
      <address>
        <city>Ermont</city>
        <zip>95120</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Thomas, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Julie Giroud, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Luc Descotes, MD-PHD</last_name>
    </contact>
    <contact_backup>
      <last_name>Mathieu Laramas, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital privé Toulon - Sainte Marguerite</name>
      <address>
        <city>Hyères</city>
        <zip>83400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mael Martin, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Philippe Bernard, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital du Kremlin-Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacques Irani, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Vincent</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Louis Bonnal</last_name>
    </contact>
    <contact_backup>
      <last_name>Sylvie Berger</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital privé de la Louvière</name>
      <address>
        <city>Lille</city>
        <zip>59800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre Colin, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Olvier Romano, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Philibert</name>
      <address>
        <city>Lomme</city>
        <zip>59462</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Louis Bonnal</last_name>
    </contact>
    <contact_backup>
      <last_name>Sylvie Berger</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Insitut Paoli Calmette</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Géraldine Pignot, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Gwenaelle Gravis, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric LECHEVALLIER, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Jean-Laurent DEVILLE, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Nîmes</name>
      <address>
        <city>Nîmes</city>
        <zip>30900</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane Droupy, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Nadine Houédé, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc-Olivier Timsit, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Constance Thibault, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Masson-Lecomte, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Hélène Gautier, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Durand</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Barry Delongchamps, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Olivier Huillard</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafael Sanchez-Salas, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Mostefa Bennamoun, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier Traxer, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Ahmed Khalil, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital Diaconesses- Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Sebe, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Camille Serrate, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Morgan Roupret, MD-PHD</last_name>
    </contact>
    <contact_backup>
      <last_name>Baptiste Abbar, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69130</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain Ruffion, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Denis Maillet, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre CARIO-HPCA</name>
      <address>
        <city>Plérin</city>
        <zip>22198</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luc Corbel</last_name>
    </contact>
    <contact_backup>
      <last_name>Dominique Besson</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Mathieu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpitaux d'instruction des armées Begin</name>
      <address>
        <city>Saint-Mandé</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hugo Picchi, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Marie Dusaud, MD-PHD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yann Neuzillet, MD-PHD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Leman</name>
      <address>
        <city>Thonon-les-Bains</city>
        <zip>74200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien Pouessel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Tours</name>
      <address>
        <city>Tours</city>
        <zip>3700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck Bruyère, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Claude Linassier, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yohann Loriot, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sara Martinez Breijo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Jerez de la Frontera</name>
      <address>
        <city>Cadiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Álvaro Juárez Soto, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Álvaro Sánchez González, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mario Álvarez Maestro, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tomás Fernández Aparicio, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Marta Zafra Poves, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>Santa Cruz De Tenerife</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ana Cristina Plata Bello, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</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>
    <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
    <mesh_term>BCG Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients</ipd_description>
  </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/NCT03799835
org study id: UC-0160/1717
secondary id: 2017-004512-19
nct id: NCT03799835
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle
      invasive bladder cancer who had never received BCG for this disease.

      The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free
      survival.
ALBAN study will randomize 516 patients in 45 centers in Europe (France, Belgium and Spain),
      according to a ratio 1:1 in the following arms of treatment:

        -  Arm A (control arm): BCG only

        -  Arm B (experimental arm): BCG+ atezolizumab

      The are two factors of stratifications (center and CIS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence-free survival
time frame: 2 years
description: Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy.
measure: Progression-free survival
time frame: From randomization to the date of progression, assessed up to 5 years
description: Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse.
measure: Disease-specific survival
time frame: From randomization to the date of death, assessed up to 5 years
description: Disease-specific survival defined as the time from randomization to the date of death from bladder cancer.
measure: Overall Survival
time frame: From randomization to the date of death, assessed up to 5 years
description: Overall Survival defined as the time from randomization to the date of death from any cause.
measure: Disease worsening in each arm
time frame: From randomization to the date of death, assessed up to 5 years
description: Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening.
measure: Complete response in each arm
time frame: 6 weeks and 2 years after randomization
description: Complete response is assessed by cystoscopy and cytology.
measure: Complete response among patients with CIS
time frame: 6 weeks and 2 years after randomization
description: Complete response is assessed by cystoscopy and cytology.
measure: National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
time frame: Throughout study completion, assessed up to 5 years
description: The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE).
measure: Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC)
time frame: At randomization, every 12 weeks for years 1 and 2 after randomization, then every 24 weeks for years 3 to 5 after randomization
description: This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
arm group label: Arm A : control arm
arm group type: Active Comparator
description: BCG therapy only
BCG therapy will be administered in two phases:
induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
arm group label: Arm B: experimental arm
arm group type: Experimental
description: BCG therapy + administration of atezolizumab
BCG therapy will be administered in two phases:
induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).
intervention type: Drug
intervention name: BCG
description: Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®
arm group label: Arm A : control arm
arm group label: Arm B: experimental arm
other name: Bacillus Calmette Guerin (BCG) Medac®
other name: OncoTice
intervention type: Drug
intervention name: Atezolizumab
description: IV perfusion
arm group label: Arm B: experimental arm
other name: MPDL3280A
other name: Tecentriq®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Morgan Roupret, MD-PHD
role: Principal Investigator
affiliation: Hôpital Pitié-Salpétrière
last name: Yohann Loriot, MD
role: Principal Investigator
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
last name: Soazig Nénan-Le Ficher
phone: +33185343113
email: s-nenan@unicancer.fr
last name: Maggy Chausson
phone: +33185343112
phone ext: +33185343112
email: m-chausson@unicancer.fr
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
country: Belgium
country: France
country: Spain
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
mesh term: Atezolizumab
mesh term: BCG Vaccine
sharing ipd: No
ipd description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients