<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/NCT02989584</url>
  </required_header>
  <id_info>
    <org_study_id>16-1428</org_study_id>
    <nct_id>NCT02989584</nct_id>
  </id_info>
  <brief_title>A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer</brief_title>
  <official_title>A Pilot Safety Study and Single Arm Phase II Study of Gemcitabine and Cisplatin With Atezolizumab (MPDL3280A) in Patients With Metastatic and Muscle Invasive Bladder Cancer, Respectively</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the safety of the study drug, atezolizumab, when&#xD;
      combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study&#xD;
      will help researchers begin to understand whether combining GC with atezolizumab is better,&#xD;
      the same, or worse than the usual approach of using GC alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 20, 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test the safety of atezolizumab in combination with gemcitabine/cisplatin as assessed by dose limiting toxicity rate.</measure>
    <time_frame>Participants will be followed for survival until 5 years from treatment completion or until disease recurrence/progression.</time_frame>
    <description>CTCAE version 4.0 will be used for all patients on this trial for evaluation of toxicities during systemic therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse-Free Survival</measure>
    <time_frame>3 years</time_frame>
    <description>Relapse-Free Survival by RECIST v1.1 is measured from the time of treatment initiation until the first date that disease progression is objectively documented.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Bladder Cancer</condition>
  <condition>Metastatic Bladder Cancer</condition>
  <condition>Urothelial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Atezolizumab, Gemcitabine, Cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a two phase study with a single study arm for each phase.&#xD;
For Phase 1: Following enrollment participants will be treated with combination therapy on a 21 day cycle x 6 cycles. Gemcitabine (1000 mg/m2 on Day 1 and Day 8), cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.&#xD;
Phase 2: Following enrollment participants will be treated with a single dose of atezolizumab alone followed by combination therapy on a 21-day cycle x 4 cycles, followed by a single dose of atezolizumab alone. Gemcitabine 1000mg/m2, cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <arm_group_label>Atezolizumab, Gemcitabine, Cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <arm_group_label>Atezolizumab, Gemcitabine, Cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <arm_group_label>Atezolizumab, Gemcitabine, Cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  ECOG Performance Status of 0 or 1&#xD;
&#xD;
          -  Required Initial Laboratory Values within 14 days of enrollment:&#xD;
&#xD;
               -  Absolute Neutrophil Count ≥ 1500 cells/mm^3&#xD;
&#xD;
               -  Lymphocyte count ≥ 300/mm^3&#xD;
&#xD;
               -  Platelets ≥ 100,000 cells/mm^3&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
               -  Bilirubin ≤ 1.5 the upper limit of normal (ULN) for the institution For patients&#xD;
                  with known Gilbert's disease: bilirubin ≤ 3 x ULN&#xD;
&#xD;
               -  Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN for the&#xD;
                  institution.&#xD;
&#xD;
                    -  For patients in the metastatic cohort with documented liver or bone&#xD;
                       metastases: AST and/or ALT ≤ 5.0 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN for the institution&#xD;
&#xD;
                    -  For patients in the metastatic cohort with documented liver or bone&#xD;
                       metastases: alkaline phosphatase ≤ 5 x ULN&#xD;
&#xD;
               -  If female of childbearing potential, urine pregnancy test is negative.&#xD;
&#xD;
               -  INR and aPTT ≤ 1.5 x ULN if not on therapeutic anticoagulation. Patients&#xD;
                  receiving therapeutic anticoagulation should be on a stable dose.&#xD;
&#xD;
        Phase I Cohort&#xD;
&#xD;
          -  Archival tumor specimens must be submitted prior to enrollment. Samples collected from&#xD;
             fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases,&#xD;
             and lavage are not acceptable. Acceptable samples include core-needle biopsies for&#xD;
             deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or&#xD;
             forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. If archival tissue&#xD;
             is being used, representative urothelial carcinoma FFPE tumor specimens (tumor blocks&#xD;
             or 30 unstained slides) must be provided. Patients with &lt; 30 slides may be enrolled&#xD;
             after discussion with the principal investigator. Primary or metastatic specimens may&#xD;
             be submitted.&#xD;
&#xD;
          -  Subject must agree to undergo two research-directed biopsies during treatment.&#xD;
&#xD;
          -  The patient must have measurable disease according to RECIST v1.1 and must have one&#xD;
             site amenable to biopsy that, in the opinion of the investigator and/or interventional&#xD;
             radiologist, is likely to yield acceptable tumor sample for a core biopsy per the&#xD;
             above pathology criteria.&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks&#xD;
&#xD;
          -  Histologically or cytologically confirmed urothelial carcinoma (confirmed at the&#xD;
             enrolling institution) of the bladder, ureter, urethra, or renal pelvis. Patients with&#xD;
             mixed histologies are required to have a predominant urothelial component as reviewed&#xD;
             by the pathologist at the treating institution.&#xD;
&#xD;
          -  Locally advanced (T4b, any N; any T, N2-3) or metastatic (M1) disease as determined by&#xD;
             the treating investigator&#xD;
&#xD;
          -  Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 using the CKD- EPI equation:&#xD;
             eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age°x 1.018 [if female] x&#xD;
             1.159 [if black] Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is&#xD;
             -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and&#xD;
             max indicates the maximum of Scr/k or 1&#xD;
&#xD;
        Phase 2 Cohort&#xD;
&#xD;
          -  Pathology: Representative urothelial carcinoma FFPE tumor specimens (tumor blocks or&#xD;
             30 unstained slides). Patients with &lt; 30 slides may be enrolled after discussion with&#xD;
             the principal investigator.&#xD;
&#xD;
          -  Muscle invasive urothelial carcinoma of the bladder histologically confirmed at the&#xD;
             enrolling institution. (Urothelial carcinoma invading into the prostatic stroma with&#xD;
             no histologic muscle invasion is allowed provided the extent of disease is confirmed&#xD;
             via imaging and/or EUA.)&#xD;
&#xD;
          -  Clinical stage T2-4a;N0/X;M0&#xD;
&#xD;
          -  Medically appropriate candidate for radical cystectomy, as per MSK or participating&#xD;
             site Attending Urologic Oncologist&#xD;
&#xD;
          -  Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 using the CKD- EPI equation:&#xD;
             eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age°x 1.018 [if female] x&#xD;
             1.159 [if black] Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is&#xD;
             -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and&#xD;
             max indicates the maximum of Scr/k or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of NYHA functional class III or IV heart disease&#xD;
&#xD;
          -  Serious intercurrent medical or psychiatric illness, including serious active&#xD;
             infection&#xD;
&#xD;
          -  Preexisting sensory grade ≥ 2 neuropathy&#xD;
&#xD;
          -  Preexisting grade ≥ 2 hearing loss&#xD;
&#xD;
          -  Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of&#xD;
             need for a major surgical procedure during the course of the study. Transurethral&#xD;
             resection or other urinary tract diagnostic procedures, excisional biopsy, or MediPort&#xD;
             placement, are NOT defined as major surgical procedures.&#xD;
&#xD;
          -  Any of the following within the 6 months prior to study drug administration:&#xD;
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass&#xD;
             graft, symptomatic congestive heart failure, cerebrovascular accident, or transient&#xD;
             ischemic attack&#xD;
&#xD;
          -  Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2. However, stable&#xD;
             atrial fibrillation controlled medically or with a device (e.g. pacemaker) or prior&#xD;
             ablation is allowed.&#xD;
&#xD;
          -  History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency&#xD;
             syndrome (AIDS)-related illness&#xD;
&#xD;
          -  Concurrent treatment on another clinical trial; supportive care trials or&#xD;
             non-treatment trials, e.g. QOL, are allowed&#xD;
&#xD;
          -  Pregnancy, lactation, or breast-feeding. Patients must be surgically sterile,&#xD;
             postmenopausal, or must agree to use effective contraception during the period of&#xD;
             therapy and for 5 months after the last dose of atezolizumab. The definition of&#xD;
             effective contraception will be based on the judgment of the principal investigator or&#xD;
             a designated associate. Male patients must be surgically sterile or agree to use&#xD;
             effective contraception. Male patients will be encouraged to notify the study team if&#xD;
             their female partner becomes pregnant while on study.&#xD;
&#xD;
          -  History of autoimmune disease, including but not limited to myasthenia gravis,&#xD;
             myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,&#xD;
             inflammatory bowel disease, Wegener's granulomatosis, vascular thrombosis associated&#xD;
             with antiphospholipid syndrome, Sjogren's syndrome, Guillain-Barre syndrome, multiple&#xD;
             sclerosis, systemic vasculitis, or glomerulonephritis.&#xD;
&#xD;
               -  Patients with history of autoimmune related hypothyroidism on stable dose of&#xD;
                  thyroid replacement hormone may be eligible for this study&#xD;
&#xD;
               -  Patients with controlled Type I diabetes mellitus on a stable dose of insulin may&#xD;
                  be eligible for this study&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),&#xD;
             organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing&#xD;
             pneumonia, etc.), or evidence of active pneumonitis on screening chest computed&#xD;
             tomography (CT) scan&#xD;
&#xD;
               -  History of radiation pneumonitis in the radiation field (fibrosis) is permitted.&#xD;
&#xD;
          -  Patients with active hepatitis B virus (HBV, chronic or acute, defined as having a&#xD;
             positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C&#xD;
             antibody&#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 Cycle 1, Day&#xD;
&#xD;
                  1 and confirmed to be negative.&#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;
          -  Active tuberculosis or BCG infection&#xD;
&#xD;
          -  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;
          -  Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1. Abnormal&#xD;
             urinalysis does not constitute signs/symptoms of infection unless urine culture&#xD;
             obtained at screening grows ≥ 100,000 colonies of bacteria. Patients with an ileal&#xD;
             conduit and a urinalysis and/or culture that are abnormal are eligible unless they&#xD;
             have peripheral blood WBC &gt; ULN, fever, or other symptoms suggestive of a urinary&#xD;
             tract infection.&#xD;
&#xD;
          -  Therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1&#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;
          -  Prior allogeneic stem cell or solid organ transplant&#xD;
&#xD;
          -  Administration of intravesical bacillus Calmette-Guerin (BCG) within 4 weeks before&#xD;
             Cycle 1, Day 1&#xD;
&#xD;
          -  Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or&#xD;
             anticipation that 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 to March). Patients must not receive live, attenuated influenza vaccine&#xD;
                  (e.g., FluMist ®) within 4 weeks prior to Cycle 1, Day 1 or at any time during&#xD;
                  the study.&#xD;
&#xD;
          -  AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for&#xD;
             alopecia&#xD;
&#xD;
          -  Bisphosphonate therapy for symptomatic hypercalcemia&#xD;
&#xD;
               -  Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or&#xD;
                  osteoporosis) is allowed.&#xD;
&#xD;
          -  Known clinically significant liver disease, including active viral, alcoholic, or&#xD;
             other hepatitis; cirrhosis; and inherited liver disease&#xD;
&#xD;
          -  Patients with a history of or active bone marrow disorders expected to interfere with&#xD;
             study therapy (e.g. acute leukemias, accelerated/blast-phase chronic myelogenous&#xD;
             leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or&#xD;
             non-secretory myeloma)&#xD;
&#xD;
          -  Known primary central nervous system (CNS) malignancy, active or untreated CNS&#xD;
             metastases, symptomatic CNS metastases, and/or leptomeningeal disease&#xD;
&#xD;
          -  Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with&#xD;
             dermatologic manifestations only (e.g., patients with psoriatic arthritis would be&#xD;
             excluded) are permitted provided that they meet the following conditions:&#xD;
&#xD;
               -  Patients with psoriasis must have a baseline ophthalmologic exam to rule out&#xD;
                  ocular manifestations&#xD;
&#xD;
               -  Rash must cover less than 10% of body surface area (BSA)&#xD;
&#xD;
               -  Disease is well controlled at baseline and only requiring low potency topical&#xD;
                  steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone&#xD;
                  0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)&#xD;
&#xD;
               -  No acute exacerbations of underlying condition within the last 12 months (not&#xD;
                  requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids,&#xD;
                  biologic agents, oral calcineurin inhibitors; high potency or oral steroids)&#xD;
&#xD;
          -  Any other diseases, 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;
          -  Malignancies other than the disease under study within 5 years prior to Cycle 1, Day&#xD;
             1, with the exception of those with a negligible risk of metastasis or death and with&#xD;
             expected curative outcome (such as adequately treated carcinoma in situ of the cervix,&#xD;
             basal or squamous cell skin cancer, localized prostate cancer treated surgically with&#xD;
             curative intent, or ductal carcinoma in situ treated surgically with curative intent)&#xD;
             or undergoing active surveillance per standard-of-care management (e.g. prostate&#xD;
             cancer with Gleason score ≤ 6, and prostate-specific antigen [PSA] 10 mg/mL, etc).&#xD;
&#xD;
        Medication-Related Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with anti-PD-1, and CTLA-4, or anti-a PD-L1 therapeutic antibody or&#xD;
             pathway-targeting agents&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents (including but not limited to&#xD;
             interferon [IFN]-a or interleukin [IL]-2) within 6 weeks or five half-lives of the&#xD;
             drug (whichever is shorter) prior to Cycle 1, Day 1&#xD;
&#xD;
          -  Concomitant use of another investigational agent and/or treatment with an&#xD;
             investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five&#xD;
             half-lives of the investigational product, whichever is longer)&#xD;
&#xD;
          -  Treatment with systemic immunosuppressive medications (including but not limited to&#xD;
             prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor&#xD;
             necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1&#xD;
&#xD;
               -  Patients who have received acute, low-dose, systemic immunosuppressant&#xD;
                  medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.&#xD;
&#xD;
               -  The use of inhaled corticosteroids or mineralocorticoids (e.g., fludrocortisone)&#xD;
                  for patients with orthostatic hypotension or adrenocortical insufficiency is&#xD;
                  allowed.&#xD;
&#xD;
          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Known hypersensitivity to Chinese hamster ovary cell products or any component of the&#xD;
             atezolizumab formulation&#xD;
&#xD;
        Phase I Cohort&#xD;
&#xD;
          -  Prior chemotherapy or immunotherapy for metastatic urothelial bladder cancer. Prior&#xD;
             neoadjuvant or adjuvant chemotherapy with first progression &gt; 12 months is allowed.&#xD;
&#xD;
          -  Any approved anti-cancer therapy within 3 weeks prior to enrollment with the following&#xD;
             exceptions:&#xD;
&#xD;
               -  Palliative radiotherapy for bone metastases must be completed &gt; 7 days prior to&#xD;
                  baseline imaging and &gt; 21 days prior to cycle 1 day 1 of treatment.&#xD;
&#xD;
               -  Hormone replacement therapy or oral contraceptives are permitted&#xD;
&#xD;
               -  Administration of intravesical bacillus Calmette-Guerin (BCG) &gt;4 weeks before&#xD;
                  Cycle 1, Day 1 is allowed&#xD;
&#xD;
          -  Tumor-related pain increased above baseline for 2 weeks and not controlled by a stable&#xD;
             dose of opiates&#xD;
&#xD;
          -  Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling drainage&#xD;
             catheters allowed)&#xD;
&#xD;
        Phase 2 Cohort&#xD;
&#xD;
          -  Prior systemic chemotherapy (prior intravesical therapy is allowed)&#xD;
&#xD;
          -  Prior radiation therapy to the bladder&#xD;
&#xD;
          -  Any approved anti-cancer therapy within 3 weeks prior to enrollment&#xD;
&#xD;
          -  Administration of intravesical bacillus Calmette-Guerin (BCG) &gt;4 weeks before Cycle 1,&#xD;
             Day 1 is allowed&#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>Samuel Funt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hartford Healthcare Cancer Institute @ Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bladder cancer</keyword>
  <keyword>metastatic bladder cancer</keyword>
  <keyword>atezolizumab</keyword>
  <keyword>urothelial carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02989584
org study id: 16-1428
nct id: NCT02989584
lead sponsor: 
collaborator: 
The purpose of this study is to test the safety of the study drug, atezolizumab, when
      combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study
      will help researchers begin to understand whether combining GC with atezolizumab is better,
      the same, or worse than the usual approach of using GC alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Test the safety of atezolizumab in combination with gemcitabine/cisplatin as assessed by dose limiting toxicity rate.
time frame: Participants will be followed for survival until 5 years from treatment completion or until disease recurrence/progression.
description: CTCAE version 4.0 will be used for all patients on this trial for evaluation of toxicities during systemic therapy.
measure: Relapse-Free Survival
time frame: 3 years
description: Relapse-Free Survival by RECIST v1.1 is measured from the time of treatment initiation until the first date that disease progression is objectively documented.
arm group label: Atezolizumab, Gemcitabine, Cisplatin
arm group type: Experimental
description: This is a two phase study with a single study arm for each phase.
For Phase 1: Following enrollment participants will be treated with combination therapy on a 21 day cycle x 6 cycles. Gemcitabine (1000 mg/m2 on Day 1 and Day 8), cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.
Phase 2: Following enrollment participants will be treated with a single dose of atezolizumab alone followed by combination therapy on a 21-day cycle x 4 cycles, followed by a single dose of atezolizumab alone. Gemcitabine 1000mg/m2, cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.
intervention type: Drug
intervention name: Atezolizumab
arm group label: Atezolizumab, Gemcitabine, Cisplatin
intervention type: Drug
intervention name: Gemcitabine
arm group label: Atezolizumab, Gemcitabine, Cisplatin
intervention type: Drug
intervention name: Cisplatin
arm group label: Atezolizumab, Gemcitabine, Cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Funt, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
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country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Carcinoma, Transitional Cell
mesh term: Gemcitabine
mesh term: Atezolizumab