<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/NCT03294304</url>
  </required_header>
  <id_info>
    <org_study_id>2017LS039</org_study_id>
    <nct_id>NCT03294304</nct_id>
  </id_info>
  <brief_title>BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy</brief_title>
  <official_title>BLASST-1 (Bladder Cancer Signal Seeking Trial): Phase II Trial of Neoadjuvant Nivolumab With Cisplatin and Gemcitabine in Muscle-Invasive Bladder Cancer (MIBC) Patients Undergoing Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</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 a multi-center Phase II study to determine the safety and efficacy of nivolumab when&#xD;
      given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with&#xD;
      muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients&#xD;
      will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin&#xD;
      (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical&#xD;
      cystectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2018</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 5, 2020</primary_completion_date>
  <phase>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>Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)</measure>
    <time_frame>Surgery Day 1</time_frame>
    <description>Incidence of Measurable Disease &quot;pT&quot; in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a &quot;flat tumor&quot; stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)</measure>
    <time_frame>Treatment Day 1 of cycle 1</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)</measure>
    <time_frame>Treatment Day 8 of cycle 1</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)</measure>
    <time_frame>Treatment Day 1 of cycle 2</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)</measure>
    <time_frame>Treament day 8 of cycle 2</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)</measure>
    <time_frame>Treatment day 1 of cycle 3</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)</measure>
    <time_frame>Treatment day 8 of cycle 3</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)</measure>
    <time_frame>Treatment day 1 of cycle 4</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)</measure>
    <time_frame>Treatment day 8 of cycle 4</time_frame>
    <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin</measure>
    <time_frame>30 Days +/- 7 Days after last chemotherapy</time_frame>
    <description>Incidence of Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Nivolumab With Gemcitabine/Cisplatin</measure>
    <time_frame>4 weeks post radical cystectomy</time_frame>
    <description>Incidence of Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants Experiencing Progression Free Survival (PFS)</measure>
    <time_frame>Every 3 Months for 2 Years</time_frame>
    <description>Count of participants experiencing Progression Free Survival (PFS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Muscle Invasive Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Nivolumab, Cisplatin, &amp; Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.</description>
    <arm_group_label>Nivolumab, Cisplatin, &amp; Gemcitabine</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.</description>
    <arm_group_label>Nivolumab, Cisplatin, &amp; Gemcitabine</arm_group_label>
    <other_name>Platinol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
    <arm_group_label>Nivolumab, Cisplatin, &amp; Gemcitabine</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of MIBC (predominantly urothelial carcinoma) with clinical stage T2-T4a and&#xD;
             N&lt;1 disease (solitary lymph node measuring &lt; 2 cm) and M0 and deemed eligible for&#xD;
             radical cystectomy.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  ECOG Performance Status of 0 or 1.&#xD;
&#xD;
          -  Required initial laboratory values within 14 days of study enrollment:&#xD;
&#xD;
               -  Absolute Neutrophil Count ≥ 1500 cells/mm^3&#xD;
&#xD;
               -  Platelets ≥ 100,000 cells/mm^3&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
               -  Bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the institution (For&#xD;
                  patients 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;
               -  Creatinine clearance ≥ 50 ml/min by Cockcroft-Gault formula or 24 hour urinary&#xD;
                  clearance (CrCl = [140-age (years)] x actual weight (kg) / [72 x serum Cr&#xD;
                  (mg/dL)] (if patient is female multiply the above by 0.85) or 24 hour urinary&#xD;
                  creatinine clearance.&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN for the institution&#xD;
&#xD;
               -  INR and aPTT ≤ 1.5 x ULN if not on therapeutic anticoagulation. Patients&#xD;
                  receiving therapeutic anticoagulation will be allowed if maintained on a stable&#xD;
                  dose.&#xD;
&#xD;
          -  Females of childbearing potential and males who are not surgically sterile and with&#xD;
             partners of childbearing potential must agree to use effective contraception during&#xD;
             study treatment for 5 months for females and 7 months for males after the last dose of&#xD;
             nivolumab.&#xD;
&#xD;
          -  Ability to provide a signed and dated consent or have a legally authorized&#xD;
             representative to provide written and signed consent prior to the initiation of any&#xD;
             research related procedures.&#xD;
&#xD;
          -  Patient must agree to submission of archived tumor (20-25 formalin-fixed paraffin&#xD;
             embedded (FFPE) slides of 5-10 microns in thickness) from TURBT and radical cystectomy&#xD;
             tissues. If archived samples are not available fresh tissue will be used.&#xD;
&#xD;
          -  Ability to provide written consent prior to the initiation of any research related&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of N2-3 or M1 disease.&#xD;
&#xD;
          -  Ineligible to receive cisplatin by meeting one or more of the following criteria;&#xD;
&#xD;
               -  Creatinine clearance of &lt; 50 mL/min&#xD;
&#xD;
               -  Hearing loss of 25 dB at two contiguous frequencies with testing required if a&#xD;
                  patient has hearing loss - At the investigator's discretion, and after discussion&#xD;
                  with the patient, this exclusion may be waived if the potential benefit of&#xD;
                  cisplatin therapy is felt to outweigh the risk of further hearing loss.&#xD;
&#xD;
               -  CTCAE v4 Grade 2 or higher peripheral neuropathy,&#xD;
&#xD;
               -  New York Heart Association Class III or IV heart failure&#xD;
&#xD;
               -  ECOG performance status 2 or higher.&#xD;
&#xD;
          -  Prior systemic therapy (intravenous) is not permitted. Prior intravesical therapies&#xD;
             including intravesical gemcitabine is permitted for non-muscle invasive disease (i.e.&#xD;
             T1 or lower).&#xD;
&#xD;
          -  Prior treatment with cisplatin for bladder cancer.&#xD;
&#xD;
          -  Prior treatment with anti-PD-1, CTLA-4, or anti-PD-L1 therapeutic antibody or&#xD;
             pathway-targeting agents.&#xD;
&#xD;
          -  Prior therapeutic radiation to the bladder.&#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.&#xD;
&#xD;
          -  Any of the following within the 6 months prior to study drug administration:&#xD;
             myocardial infarction, severe/unstable angina, symptomatic congestive heart failure&#xD;
             (&gt;New York Heart Association Class 2), stroke, serious cardiac arrhythmia.&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome&#xD;
             (AIDS)-related illness.&#xD;
&#xD;
          -  Pregnancy, lactation, or breast-feeding. Women of childbearing potential must have a&#xD;
             negative urine pregnancy test at screening.&#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;
          -  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, history of radiation pneumonitis in the radiation field&#xD;
             (fibrosis) is permitted.&#xD;
&#xD;
          -  Active hepatitis B virus (HBV, chronic or acute, defined as having a positive&#xD;
             hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C antibody.&#xD;
             Patients with past HBV infection or resolved HBV infection (defined as the presence of&#xD;
             hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible. HBV DNA must be&#xD;
             obtained in these patients prior to Cycle 1, Day 1 and confirmed to be negative.&#xD;
             Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase&#xD;
             chain reaction is negative for HCV RNA.&#xD;
&#xD;
          -  Active tuberculosis or BCG infection&#xD;
&#xD;
          -  Active infection requiring systemic antibiotics for more than 7 days within 3 days&#xD;
             prior to Cycle 1, Day 1. Prophylactic short-term antibiotics will be allowed.&#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;
          -  Persisting toxicity from prior therapy (NCI CTCAE v4.03 Grade &gt;1); however alopecia or&#xD;
             other Grade &lt;2 AEs not constituting a safety risk, based on Investigator's judgement,&#xD;
             are acceptable.&#xD;
&#xD;
          -  History of or active bone marrow disorders expected to interfere with study therapy&#xD;
             (e.g. acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic&#xD;
             lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory&#xD;
             myeloma).&#xD;
&#xD;
          -  Prior allogeneic stem cell or solid organ transplant.&#xD;
&#xD;
          -  Known primary central nervous system (CNS) malignancy.&#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 but patients with psoriasis require a baseline ophthalmologic&#xD;
             exam to rule out ocular manifestations. Rash must cover less than 10% of body surface&#xD;
             area (BSA) and must be well controlled at baseline and only requiring topical&#xD;
             steroids.&#xD;
&#xD;
          -  Any other chronic medical condition or psychiatric condition, physical examination&#xD;
             finding, or clinical laboratory finding giving reasonable suspicion of a disease or&#xD;
             condition that contraindicates the use of an investigational drug or that may affect&#xD;
             the interpretation of the results or render the patient at high risk from treatment&#xD;
             complications&#xD;
&#xD;
          -  Known additional malignancy that is progressing or requires active treatment.&#xD;
             Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the&#xD;
             skin or in situ cervical cancer that has undergone potentially curative therapy.&#xD;
             Patients on androgen deprivation therapy as part of adjuvant therapy after radiation&#xD;
             for prostate cancer or patients on adjuvant hormonal therapies for breast cancer will&#xD;
             be allowed if they are being considered for curative intent for bladder cancer.&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents (including but not limited to&#xD;
             interferon [IFN]-a or interleukin [IL]-2) within 4 weeks or five half-lives of the&#xD;
             drug (whichever is shorter) prior to Cycle 1, Day 1&#xD;
&#xD;
          -  Concomitant use of systemic corticosteroids at physiologic doses or &lt;10 mg/day of&#xD;
             prednisone or equivalent.&#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 halflives&#xD;
             of the investigational product, whichever is longer).&#xD;
&#xD;
          -  Use of bisphosphonate therapy for osteoporosis will be allowed if started prior to&#xD;
             study enrollment.&#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>Badrinath Konety, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masonic Cancer Center, University of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shilpa Gupta, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Cleveland Clinic Taussig Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masonic Cancer Center - University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute - University of Utah Health</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>June 3, 2021</results_first_submitted>
  <results_first_submitted_qc>November 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 16, 2021</results_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MIBC</keyword>
  <keyword>UC</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Bladder Cancer</keyword>
  <keyword>Neoadjuvant</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>Gemcitabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03294304/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
          <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
          <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)</title>
        <description>Incidence of Measurable Disease &quot;pT&quot; in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a &quot;flat tumor&quot; stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.</description>
        <time_frame>Surgery Day 1</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)</title>
          <description>Incidence of Measurable Disease &quot;pT&quot; in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a &quot;flat tumor&quot; stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment Day 1 of cycle 1</time_frame>
        <population>2 participants were not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants were not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment Day 8 of cycle 1</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment Day 1 of cycle 2</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treament day 8 of cycle 2</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment day 1 of cycle 3</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment day 8 of cycle 3</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment day 1 of cycle 4</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)</title>
        <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
        <time_frame>Treatment day 8 of cycle 4</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)</title>
          <description>Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin</title>
        <description>Incidence of Adverse Events</description>
        <time_frame>30 Days +/- 7 Days after last chemotherapy</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin</title>
          <description>Incidence of Adverse Events</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Nivolumab With Gemcitabine/Cisplatin</title>
        <description>Incidence of Adverse Events</description>
        <time_frame>4 weeks post radical cystectomy</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Nivolumab With Gemcitabine/Cisplatin</title>
          <description>Incidence of Adverse Events</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants Experiencing Progression Free Survival (PFS)</title>
        <description>Count of participants experiencing Progression Free Survival (PFS)</description>
        <time_frame>Every 3 Months for 2 Years</time_frame>
        <population>2 participants are not evaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
            <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants Experiencing Progression Free Survival (PFS)</title>
          <description>Count of participants experiencing Progression Free Survival (PFS)</description>
          <population>2 participants are not evaluable</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>120 days after last dose nivolumab</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nivolumab, Cisplatin, &amp; Gemcitabine</title>
          <description>Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.&#xD;
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.&#xD;
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE v4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Reproductive system and breast disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE v4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="61" subjects_affected="25" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Blood and lymphatic system disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Congenital, familial and genetic disorders - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hearing impaired</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Eyelid function disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Watering eyes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="37" subjects_affected="31" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Salivary duct inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="37" subjects_affected="30" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify</sub_title>
                <counts group_id="E1" events="29" subjects_affected="13" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Immune system disorders - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Papulopustular rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="18" subjects_affected="12" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Cardiac troponin I increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Cholesterol high</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hemoglobin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="40" subjects_affected="20" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="13" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="29" subjects_affected="18" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="10" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="12" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="10" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nervous system disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="12" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Reproductive system and breast disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Uterine pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Vaginal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic rhinitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Sleep apnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="24" subjects_affected="15" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Superficial thrombophlebitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Konety Badrinath</name_or_title>
      <organization>Masonic Cancer Center, University of Minnesota</organization>
      <phone>612-625-1655</phone>
      <email>brkonety@umn.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03294304
org study id: 2017LS039
nct id: NCT03294304
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when
      given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with
      muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients
      will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin
      (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical
      cystectomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)
time frame: Surgery Day 1
description: Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
time frame: Treatment Day 1 of cycle 1
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
time frame: Treatment Day 8 of cycle 1
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
time frame: Treatment Day 1 of cycle 2
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
time frame: Treament day 8 of cycle 2
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
time frame: Treatment day 1 of cycle 3
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
time frame: Treatment day 8 of cycle 3
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
time frame: Treatment day 1 of cycle 4
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
time frame: Treatment day 8 of cycle 4
description: Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
measure: Safety of Nivolumab With Gemcitabine/Cisplatin
time frame: 30 Days +/- 7 Days after last chemotherapy
description: Incidence of Adverse Events
measure: Safety of Nivolumab With Gemcitabine/Cisplatin
time frame: 4 weeks post radical cystectomy
description: Incidence of Adverse Events
measure: Count of Participants Experiencing Progression Free Survival (PFS)
time frame: Every 3 Months for 2 Years
description: Count of participants experiencing Progression Free Survival (PFS)
arm group label: Nivolumab, Cisplatin, & Gemcitabine
arm group type: Experimental
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
arm group label: Nivolumab, Cisplatin, & Gemcitabine
other name: Opdivo
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
arm group label: Nivolumab, Cisplatin, & Gemcitabine
other name: Platinol
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
arm group label: Nivolumab, Cisplatin, & Gemcitabine
other name: Gemzar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Badrinath Konety, MD, MBA
role: Principal Investigator
affiliation: Masonic Cancer Center, University of Minnesota
last name: Shilpa Gupta, MD
role: Study Chair
affiliation: Cleveland Clinic Taussig Cancer Institute
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Gemcitabine
mesh term: Nivolumab
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 