<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/NCT03024216</url>
  </required_header>
  <id_info>
    <org_study_id>Rosser-2015-4</org_study_id>
    <nct_id>NCT03024216</nct_id>
  </id_info>
  <brief_title>Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer</brief_title>
  <official_title>Phase Ib Study Assessing Different Sequencing Regimens of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients Who Have Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hawaii</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dendreon</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Hawaii</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the safety and tolerability of sequential atezolizumab&#xD;
      followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in&#xD;
      patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously&#xD;
      treated with docetaxel or cabazitaxel.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of AE by CTCAE v4.0</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinically significant changes in vital signs and clinical laboratory results</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using PCWG2 criteria, or death from any cause on study</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using modified RECISTv1.1, or death from any cause on study</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per PCWG2 criteria</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per modified RECISTv1.1 criteria</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of confirmed objective response in patients with measurable soft tissue disease at baseline</measure>
    <time_frame>12 months</time_frame>
    <description>Duration of confirmed objective response in patients with measurable soft tissue disease at baseline, defined as the time from first observation of an objective confirmed tumor response until first observation of disease progression or death, as assessed by the investigator per PCWG2 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of confirmed objective response in patients with measurable soft tissue disease at baseline</measure>
    <time_frame>12 months</time_frame>
    <description>Duration of confirmed objective response in patients with measurable soft tissue disease at baseline, defined as the time from first observation of an objective confirmed tumor response until first observation of disease progression or death, as assessed by the investigator per modified RECIST v1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune-Related Response Criteria (irRC) at 6 and 12 months</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Prostate Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atezolizumab1200 mg IV week 1 and week 4 followed by Sipuleucel-T administered weeks 6, 8, and 10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sipuleucel-T administered week 1, 3, and 5 followed by Atezolizumab1200 mg IV weeks 7 and 10</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab1200 mg IV</intervention_name>
    <description>Subjects in ARM 1 will receive 2 doses of atezolizumab 1200 mg intravenously (week 1 and week 4). If no dose limiting toxicity continue onto maintenance, week 13 and receive atezolizumab 1200 mg intravenously every 3 weeks until toxicities or lack of clinical benefit. Subjects in ARM 2 will receive 2 doses at approximately 3 weeks each of atezolizumab 1200 mg intravenously (weeks 7 and 10). If no dose limiting toxicity, continue to receive atezolizumab 1200 mg intravenously every 3 weeks, starting week 13, until toxicities or lack of clinical benefit.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sipuleucel-T</intervention_name>
    <description>Subjects in ARM 1 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 6, 8, 10). Subjects in ARM 2 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 1, 3 and 5)</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet the following criteria for study entry:&#xD;
&#xD;
          1. Documentation of Disease:&#xD;
&#xD;
             - Progressive castration-resistant metastatic prostate cancer with pathologically&#xD;
             confirmed adenocarcinoma of the prostate without small cell features.&#xD;
&#xD;
          2. Patients must have Measurable or Non-measurable disease per Prostate Cancer Working&#xD;
             Group 2 (PCWG2) response criteria (RECIST criteria will only apply to soft tissue&#xD;
             lesions&#xD;
&#xD;
               -  Measurable Disease&#xD;
&#xD;
                    -  For extra-nodal lesions to be considered measurable, they must be ≥ 10 mm in&#xD;
                       one dimension, using spiral CT.&#xD;
&#xD;
               -  For lymph nodes to be considered measureable (i.e., target or evaluable lesions),&#xD;
                  they must be ≥ 20 mm in at least one dimension, using spiral CT.&#xD;
&#xD;
               -  Non-measurable Disease&#xD;
&#xD;
                    -  All other lesions, including small lesions (longest diameter &lt; 20 mm with&#xD;
                       conventional techniques or &lt; 10 mm with spiral CT scan) and truly&#xD;
                       non-measurable lesions.&#xD;
&#xD;
                    -  Lesions that are considered non-measurable include bone lesions (only).&#xD;
&#xD;
          3. Asymptomatic or mildly symptomatic metastatic CRPC defined as pain that is relieved by&#xD;
             acetaminophen or a non-steroidal anti-inflammatory&#xD;
&#xD;
               -  Asymptomatic: Score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours)&#xD;
&#xD;
               -  Mildly symptomatic: Score of 2-3 on BPI-SF Question #3&#xD;
&#xD;
          4. Progressive disease:&#xD;
&#xD;
             Patients must have progressive disease at study entry defined as one or more of the&#xD;
             following three criteria that occurred while the patient was on androgen deprivation&#xD;
             therapy. For patients enrolling on the basis of soft tissue or bone progression, the&#xD;
             baseline scan must show progression relative to a comparison scan. If the comparison&#xD;
             scan is not available, the baseline scan report must reference the previous scan to&#xD;
             document progression.&#xD;
&#xD;
               -  PSA progression defined by a minimum of two rising PSA levels with an interval of&#xD;
                  ≥ 1 week between each determination. Patients who received an anti-androgen must&#xD;
                  have progression documented by a minimum of two rising PSA levels with an&#xD;
                  interval of ≥ 1 week between each determination such that at least the second of&#xD;
                  these rises is &gt; 4 weeks since last flutamide or &gt; 6 weeks since last&#xD;
                  bicalutamide or nilutamide. The PSA value at the screening should be &gt; 2 μg/L (2&#xD;
                  ng/mL)&#xD;
&#xD;
               -  Soft tissue disease progression is defined as at least a 20% increase in the sum&#xD;
                  of the diameters of target lesions, taking as reference the smallest sum on study&#xD;
                  (this includes the baseline sum if that is the smallest on study). In addition to&#xD;
                  the relative increase of 20%, the sum must also demonstrate an absolute increase&#xD;
                  of at least 5 mm. (Note: the appearance of one or more new non-osseous lesions is&#xD;
                  also considered progression). Clinical lesions will only be considered measurable&#xD;
                  when they are superficial (e.g., skin nodules, palpable lymph nodes) and at least&#xD;
                  10 mm in diameter as assessed using calipers (e.g., skin nodules). Per PCWG2:&#xD;
                  Extranodal lesions need to be ≥ 10 mm in one dimension, using spiral CT. However,&#xD;
                  lymph nodes need to be ≥ 20 mm in at least one dimension to be considered new.&#xD;
&#xD;
               -  Bone disease progression is defined by PCWG2 as two or more new lesions on bone&#xD;
                  scan&#xD;
&#xD;
          5. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin&#xD;
             blocks (blocks are preferred) or at least 10 unstained slides, with an associated&#xD;
             pathology report, for central testing of tumor PD-L1 expression&#xD;
&#xD;
               -  Tumor tissue should be of good quality based on total and viable tumor content.&#xD;
                  Fine needle aspiration, brushing, cell pellet from pleural effusion, bone&#xD;
                  metastases, and lavage samples are not acceptable. For core-needle biopsy&#xD;
                  specimens, at least three cores should be submitted for evaluation.&#xD;
&#xD;
               -  Patients who do not have tissue specimens meeting eligibility requirements may&#xD;
                  undergo a biopsy during the screening period. Acceptable samples include core&#xD;
                  needle biopsies for deep tumor tissue (minimum of three cores) or excisional,&#xD;
                  incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal&#xD;
                  lesions.&#xD;
&#xD;
               -  Tumor tissue from bone metastases is not evaluable for PD-L1 expression but will&#xD;
                  still be acceptable.&#xD;
&#xD;
          6. Patients must have been on androgen deprivation therapy with a GnRH analogue,&#xD;
             antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) for at&#xD;
             least 3 months prior to study entry and maintain castrate levels of serum testosterone&#xD;
             ≤ 50 ng/dL throughout study participation unless intolerant.&#xD;
&#xD;
          7. Adequate hematologic and end organ function, defined by the following laboratory&#xD;
             results:&#xD;
&#xD;
               -  ANC ≥ 1500 cells/uL&#xD;
&#xD;
               -  WBC counts ≥ 2500/uL&#xD;
&#xD;
               -  Lymphocyte count ≥ 300/uL&#xD;
&#xD;
               -  Platelet count ≥ 100,000/uL;&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception:&#xD;
&#xD;
                    -  Patients with known Gilbert disease who have serum bilirubin level ≤ 3 xULN&#xD;
                       may be enrolled.&#xD;
&#xD;
               -  AST/ALT ≤ 2.5 × institutional upper limit of normal&#xD;
&#xD;
                    -  For patients with documented bone metastases, AST can be ≥ 2.5x ULN if the&#xD;
                       investigator can provide evidence of no underlying liver dysfunction and&#xD;
                       thus, it is likely that the AST is originating from bone source.&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN Patients with documented bone metastases:&#xD;
                  alkaline phosphatase ≤ 5 x ULN&#xD;
&#xD;
               -  Serum creatinine ≥ 1.5 x ULN or creatinine clearance ≤50 mL/min on the basis of&#xD;
                  the Cockcroft-Gault glomerular filtration rate estimation:&#xD;
&#xD;
                    -  (140- age) x (weight in kg) x (0.85 if female) 72 x (serum creatinine in&#xD;
                       mg/dL)&#xD;
&#xD;
               -  INR and aPTT ≥1.5 x ULN - This applies only to patients who do not receive&#xD;
                  therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such&#xD;
                  as low-molecular-weight heparin or warfarin) should be on a stable dose&#xD;
&#xD;
          8. No clinically significant cardiovascular disease including:&#xD;
&#xD;
               -  MI within 6 months&#xD;
&#xD;
               -  Uncontrolled angina within 3 months&#xD;
&#xD;
               -  CHF with NYHA class 3 or 4, or patients with NYHA class 3 or 4 in the past,&#xD;
                  unless a screening echo or MUGA performed within three months demonstrates an&#xD;
                  EF&gt;45%&#xD;
&#xD;
               -  History of clinically significant ventricular arrhythmias (e.g., ventricular&#xD;
                  tachycardia, ventricular fibrillation, Torsades de pointes)&#xD;
&#xD;
               -  History of Mobitz II second degree or third degree heart block without a&#xD;
                  permanent pacemaker in place&#xD;
&#xD;
               -  Hypotension (systolic BP &lt;86 mmHg) or bradycardia (&lt;50 bpm) at screening&#xD;
&#xD;
               -  Uncontrolled hypertension (systolic BP &gt;170 mmHg or diastolic BP &gt;105 mmHg at&#xD;
                  screening)&#xD;
&#xD;
          9. For male patients with partners of childbearing potential, agreement (by patient&#xD;
             and/or partner) to use highly effective form(s) of contraception (i.e., one that&#xD;
             results in a low failure rate [&lt;1% per year] when used consistently and correctly) and&#xD;
             to continue its use for 6 months after the last dose of atezolizumab&#xD;
&#xD;
         10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1&#xD;
&#xD;
         11. Life expectancy of greater than 6 months&#xD;
&#xD;
         12. Ability and willingness to comply with the requirements of the study protocol&#xD;
&#xD;
         13. Age ≥ 18 years&#xD;
&#xD;
         14. Signed Informed Consent Form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet any of the following criteria will be excluded from study entry.&#xD;
&#xD;
          1. Any approved or investigational anticancer therapy, including chemotherapy, hormonal&#xD;
             therapy, or radiotherapy, within 4 weeks prior to initiation of study treatment.&#xD;
&#xD;
               -  Palliative radiotherapy for bone metastases ≥ 4 weeks prior to Cycle 1, Day 1 is&#xD;
                  allowed&#xD;
&#xD;
          2. Treatment for prostate cancer with any of the following:&#xD;
&#xD;
               -  Herbal products that may decrease PSA levels within 4 weeks prior to enrollment&#xD;
&#xD;
               -  Use of systemic steroids greater than the equivalent of 10 mg of&#xD;
                  prednisone/prednisolone per day within 4 weeks prior to administration of first&#xD;
                  dose.&#xD;
&#xD;
               -  Prior use of ketoconazole for within 7 days of administration of first dose.&#xD;
&#xD;
          3. AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for&#xD;
             alopecia&#xD;
&#xD;
          4. Bisphosphonate therapy for symptomatic hypercalcemia&#xD;
&#xD;
               -  Use of bisphosphonate therapy for bone metastasis is allowed.&#xD;
&#xD;
          5. The prior or concurrent use of a RANKL inhibitor denosumab&#xD;
&#xD;
          6. Planned palliative procedures for alleviation of bone pain such as radiation therapy&#xD;
             or surgery&#xD;
&#xD;
          7. Structurally unstable bone lesions suggesting impending fracture&#xD;
&#xD;
          8. Known clinically significant liver disease, including active viral, alcoholic, or&#xD;
             other hepatitis; cirrhosis; fatty liver; and inherited liver disease;&#xD;
&#xD;
               -  Patients with past or resolved hepatitis B infection (defined as having a&#xD;
                  negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc&#xD;
                  [antibody to hepatitis B core antigen] antibody test) are eligible.&#xD;
&#xD;
               -  Patients positive for hepatitis C virus (HCV) antibody are eligible only if&#xD;
                  polymerase chain reaction (PCR) is negative for HCV RNA.&#xD;
&#xD;
          9. Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia,&#xD;
             chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory&#xD;
             myeloma&#xD;
&#xD;
         10. Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases&#xD;
             will be excluded from this clinical trial because of their poor prognosis and because&#xD;
             they often develop progressive neurologic dysfunction or seizures that would confound&#xD;
             the evaluation of neurologic and other adverse events. (NOTE: patients with treated&#xD;
             epidural disease and patients with asymptomatic untreated CNS disease may be enrolled,&#xD;
             provided all of the following criteria are met:&#xD;
&#xD;
               -  Evaluable or measurable disease outside the CNS&#xD;
&#xD;
               -  No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm&#xD;
                  of the optic apparatus (optic nerves and chiasm)&#xD;
&#xD;
               -  No history of intracranial hemorrhage or spinal cord hemorrhage&#xD;
&#xD;
               -  No ongoing requirement for dexamethasone for CNS disease; patients on a stable&#xD;
                  dose of anticonvulsants are permitted.&#xD;
&#xD;
               -  No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1&#xD;
&#xD;
             Patients with asymptomatic treated CNS metastases may be enrolled, provided all the&#xD;
             criteria listed above are met as well as the following:&#xD;
&#xD;
               -  Radiographic demonstration of improvement upon the completion of CNS directed&#xD;
                  therapy and no evidence of interim progression between the completion of&#xD;
                  CNS-directed therapy and the screening radiographic study&#xD;
&#xD;
               -  No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle&#xD;
                  1, Day 1&#xD;
&#xD;
               -  Screening CNS radiographic study ≥4 weeks from completion of radiotherapy and ≥ 2&#xD;
                  weeks from discontinuation of corticosteroids&#xD;
&#xD;
         11. Patients with known liver visceral metastasis&#xD;
&#xD;
         12. Patients with bulky lymphadenopathy (i.e., &gt; 5 cm)&#xD;
&#xD;
         13. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant&#xD;
             human antibodies&#xD;
&#xD;
         14. Inability to comply with study and follow-up procedures&#xD;
&#xD;
         15. History or risk of autoimmune disease, including but not limited to systemic lupus&#xD;
             erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis&#xD;
             associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's&#xD;
             syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune&#xD;
             thyroid disease, vasculitis, or glomerulonephritis&#xD;
&#xD;
               -  Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid&#xD;
                  replacement hormone may be eligible.&#xD;
&#xD;
               -  Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may&#xD;
                  be eligible.&#xD;
&#xD;
         16. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),&#xD;
             organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing&#xD;
             pneumonia, etc.), or evidence of active pneumonitis on screening chest computed&#xD;
             tomography (CT) scan&#xD;
&#xD;
             o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.&#xD;
&#xD;
         17. Any other diseases, metabolic dysfunction, physical examination finding, or clinical&#xD;
             laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
             contraindicates the use of an investigational drug or that may affect the&#xD;
             interpretation of the results or render the patient at high risk from treatment&#xD;
             complications&#xD;
&#xD;
         18. History of HIV infection&#xD;
&#xD;
         19. Active tuberculosis&#xD;
&#xD;
         20. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to&#xD;
             hospitalization for complications of infection, bacteremia, or severe pneumonia&#xD;
&#xD;
         21. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 and/or Received&#xD;
             oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1&#xD;
&#xD;
             o Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract&#xD;
             infection or chronic obstructive pulmonary disease) are eligible.&#xD;
&#xD;
         22. 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;
         23. 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;
         24. Influenza vaccination should be given during influenza season only (approximately&#xD;
             October to March). Patients must not receive live, attenuated influenza vaccine (e.g.,&#xD;
             FluMist®) within 4 weeks prior to Cycle 1, Day 1 or within 90 days after last dose of&#xD;
             atezolizumab.&#xD;
&#xD;
         25. Prior malignancies except for adequately treated benign basal cell carcinoma or other&#xD;
             effectively treated malignancy that has been in remission for more than 3 years and is&#xD;
             considered to be cured&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jared Acoba, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hawaii</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prostate Oncology Specialists, Inc.</name>
      <address>
        <city>Marina Del Rey</city>
        <state>California</state>
        <zip>90292</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hawaii Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>May 24, 2021</last_update_submitted>
  <last_update_submitted_qc>May 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024216
org study id: Rosser-2015-4
nct id: NCT03024216
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the study is to compare the safety and tolerability of sequential atezolizumab
      followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in
      patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously
      treated with docetaxel or cabazitaxel.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of AE by CTCAE v4.0
time frame: 12 months
measure: Clinically significant changes in vital signs and clinical laboratory results
time frame: 12 months
measure: Radiographic progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using PCWG2 criteria, or death from any cause on study
time frame: 12 months
measure: Radiographic progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using modified RECISTv1.1, or death from any cause on study
time frame: 12 months
measure: Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per PCWG2 criteria
time frame: 12 months
measure: Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per modified RECISTv1.1 criteria
time frame: 12 months
measure: Duration of confirmed objective response in patients with measurable soft tissue disease at baseline
time frame: 12 months
description: Duration of confirmed objective response in patients with measurable soft tissue disease at baseline, defined as the time from first observation of an objective confirmed tumor response until first observation of disease progression or death, as assessed by the investigator per PCWG2 criteria
measure: Duration of confirmed objective response in patients with measurable soft tissue disease at baseline
time frame: 12 months
description: Duration of confirmed objective response in patients with measurable soft tissue disease at baseline, defined as the time from first observation of an objective confirmed tumor response until first observation of disease progression or death, as assessed by the investigator per modified RECIST v1.1 criteria
measure: Immune-Related Response Criteria (irRC) at 6 and 12 months
time frame: 6 and 12 months
arm group label: Arm 1
arm group type: Experimental
description: Atezolizumab1200 mg IV week 1 and week 4 followed by Sipuleucel-T administered weeks 6, 8, and 10
arm group label: Arm 2
arm group type: Experimental
description: Sipuleucel-T administered week 1, 3, and 5 followed by Atezolizumab1200 mg IV weeks 7 and 10
intervention type: Drug
intervention name: Atezolizumab1200 mg IV
description: Subjects in ARM 1 will receive 2 doses of atezolizumab 1200 mg intravenously (week 1 and week 4). If no dose limiting toxicity continue onto maintenance, week 13 and receive atezolizumab 1200 mg intravenously every 3 weeks until toxicities or lack of clinical benefit. Subjects in ARM 2 will receive 2 doses at approximately 3 weeks each of atezolizumab 1200 mg intravenously (weeks 7 and 10). If no dose limiting toxicity, continue to receive atezolizumab 1200 mg intravenously every 3 weeks, starting week 13, until toxicities or lack of clinical benefit.
arm group label: Arm 1
arm group label: Arm 2
intervention type: Drug
intervention name: Sipuleucel-T
description: Subjects in ARM 1 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 6, 8, 10). Subjects in ARM 2 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 1, 3 and 5)
arm group label: Arm 1
arm group label: Arm 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jared Acoba, MD
role: Principal Investigator
affiliation: University of Hawaii
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Atezolizumab
sharing ipd: Undecided