<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/NCT02234921</url>
  </required_header>
  <id_info>
    <org_study_id>14-116B</org_study_id>
    <nct_id>NCT02234921</nct_id>
  </id_info>
  <brief_title>Pilot Study of DRibble Vaccine for Prostate Cancer Patients</brief_title>
  <acronym>DRibble</acronym>
  <official_title>A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UbiVac</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Providence Health &amp; Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Providence Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Providence Cancer Center, Earle A. Chiles Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UbiVac</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this pilot study is to assess the safety and tolerability of DRibble&#xD;
      vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer.&#xD;
&#xD;
      This study will also assess:&#xD;
&#xD;
        -  the immune profile of tumor biopsy specimens if sites amenable to biopsy are present&#xD;
&#xD;
        -  humoral and cellular responses to cancer antigens after DRibble vaccination&#xD;
&#xD;
        -  the response to a reporter antigen vaccine (Ceravix) after DRibble vaccination&#xD;
&#xD;
      An exploratory objective is to characterize the microbiome before and after study drugs&#xD;
      administration and correlate prostate cancer responses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2014</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</primary_completion_date>
  <phase>Phase 1</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>Safety Assessment</measure>
    <time_frame>28 Weeks</time_frame>
    <description>Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune Response</measure>
    <time_frame>28 weeks</time_frame>
    <description>Patients will have 11 blood draws during the study to evaluate the immune response. In addition, patients will undergo two leukapheresis procedures and provide two biopsy samples (if cancer is amenable to safe biopsy) to evaluate immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Cancer Response to DRibble vaccine</measure>
    <time_frame>28 weeks</time_frame>
    <description>Patients will have 8 Prostate-Specific Antigen (PSA) Tests over a 22-week period and 3 CT scans over a 28-week period to assess response to treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Microbiome identification</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patients will provide 3 stool samples for microbiome identification for future research to see if there is a correlation with response to treatment.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Adenocarcinoma of the Prostate</condition>
  <arm_group>
    <arm_group_label>DRibble Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.</description>
    <arm_group_label>DRibble Vaccine</arm_group_label>
    <other_name>Cytoxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DRibble Vaccine</intervention_name>
    <description>DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.</description>
    <arm_group_label>DRibble Vaccine</arm_group_label>
    <other_name>DPV-001 DRibble vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HPV Vaccinations</intervention_name>
    <description>Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.</description>
    <arm_group_label>DRibble Vaccine</arm_group_label>
    <other_name>Ceravix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imiquimod</intervention_name>
    <description>Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.</description>
    <arm_group_label>DRibble Vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of&#xD;
             the prostate with progression after chemotherapy, combined androgen blockade and/or&#xD;
             peripheral androgen or androgen receptor suppression. Either histologic or serum&#xD;
             marker diagnosis is acceptable.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Ability to give informed consent and comply with the protocol.&#xD;
&#xD;
          -  Prior therapy with investigational agents must have been completed at least 3 weeks&#xD;
             prior to study enrollment.&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as determined by routine blood&#xD;
             tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active autoimmune disease except vitiligo or hypothyroidism.&#xD;
&#xD;
          -  Active other malignancy.&#xD;
&#xD;
          -  Known HIV positive and/or Hepatitis B or C positive.&#xD;
&#xD;
          -  Other medical or psychiatric conditions that in the opinion of the Principal&#xD;
             Investigator would preclude safe participation in protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brendan Curti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Providence Health &amp; Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence Health &amp; Services</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://oregon.providence.org/our-services/p/providence-cancer-center/</url>
    <description>Providence Cancer Center</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate</keyword>
  <keyword>Adenocarcinoma</keyword>
  <keyword>Metastatic</keyword>
  <keyword>DRibble</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Imiquimod</mesh_term>
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02234921
org study id: 14-116B
nct id: NCT02234921
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
The primary objective of this pilot study is to assess the safety and tolerability of DRibble
      vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer.

      This study will also assess:

        -  the immune profile of tumor biopsy specimens if sites amenable to biopsy are present

        -  humoral and cellular responses to cancer antigens after DRibble vaccination

        -  the response to a reporter antigen vaccine (Ceravix) after DRibble vaccination

      An exploratory objective is to characterize the microbiome before and after study drugs
      administration and correlate prostate cancer responses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety Assessment
time frame: 28 Weeks
description: Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment.
measure: Immune Response
time frame: 28 weeks
description: Patients will have 11 blood draws during the study to evaluate the immune response. In addition, patients will undergo two leukapheresis procedures and provide two biopsy samples (if cancer is amenable to safe biopsy) to evaluate immune response.
measure: Prostate Cancer Response to DRibble vaccine
time frame: 28 weeks
description: Patients will have 8 Prostate-Specific Antigen (PSA) Tests over a 22-week period and 3 CT scans over a 28-week period to assess response to treatment.
measure: Microbiome identification
time frame: 12 weeks
description: Patients will provide 3 stool samples for microbiome identification for future research to see if there is a correlation with response to treatment.
arm group label: DRibble Vaccine
arm group type: Experimental
description: Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
intervention type: Drug
intervention name: Cyclophosphamide
description: A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
arm group label: DRibble Vaccine
other name: Cytoxan
intervention type: Biological
intervention name: DRibble Vaccine
description: DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.
arm group label: DRibble Vaccine
other name: DPV-001 DRibble vaccine
intervention type: Biological
intervention name: HPV Vaccinations
description: Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.
arm group label: DRibble Vaccine
other name: Ceravix
intervention type: Drug
intervention name: Imiquimod
description: Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.
arm group label: DRibble Vaccine
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Brendan Curti, MD
role: Principal Investigator
affiliation: Providence Health & Services
facility: 
country: United States
url: http://oregon.providence.org/our-services/p/providence-cancer-center/
description: Providence Cancer Center
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Cyclophosphamide
mesh term: Imiquimod
mesh term: Vaccines
sharing ipd: No