<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/NCT02256514</url>
  </required_header>
  <id_info>
    <org_study_id>IMMV5</org_study_id>
    <secondary_id>IMMV5</secondary_id>
    <nct_id>NCT02256514</nct_id>
  </id_info>
  <brief_title>Open Label Trial of Immunotherapy for Advanced Liver Cancer</brief_title>
  <acronym>HCC</acronym>
  <official_title>Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunitor LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Immunitor Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Immunitor LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate daily dosing of oral immunotherapy&#xD;
      hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical&#xD;
      intervention or with recurrent tumor after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline&#xD;
      alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up&#xD;
      thereafter. Additional endpoints will include blood biochemistry indices and safety&#xD;
      monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline</measure>
    <time_frame>minimum 3 months</time_frame>
    <description>monthly check-up of AFP serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance</measure>
    <time_frame>minimum 3 months</time_frame>
    <description>Comparison of abdominal CT scans at baseline and 3 months later</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters</measure>
    <time_frame>3 months</time_frame>
    <description>Monthly blood biochemistry including liver function tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance</measure>
    <time_frame>3 months</time_frame>
    <description>Monthly evaluation of clinical symptoms as per ECOG performance status</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>HCC</condition>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Daily oral dose of hepcortespenlisimut-L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Daily oral dose of hepcortespenlisimut-L</intervention_name>
    <description>Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up</description>
    <arm_group_label>Daily oral dose of hepcortespenlisimut-L</arm_group_label>
    <other_name>V5</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are at least 18 years old and are willing and capable of providing&#xD;
             informed consent. Both men and non-pregnant women will be included.&#xD;
&#xD;
          -  HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan,&#xD;
             and AFP serum test higher or equal to 30 IU/ml.&#xD;
&#xD;
          -  All subjects with reproductive potential are advised to utilize effective&#xD;
             contraception throughout the course of this study.&#xD;
&#xD;
          -  Health score status at baseline.&#xD;
&#xD;
          -  Agreement to participate in the study and to give at least 3 samples of blood for lab&#xD;
             tests.&#xD;
&#xD;
          -  Readily available home or o other address where patient can be found.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who might have already taken V5 in prior trials and have no baseline data.&#xD;
&#xD;
          -  Those who met inclusion criteria can be retrospectively enrolled.&#xD;
&#xD;
          -  Pregnant or breast-feeding women are excluded.&#xD;
&#xD;
          -  Subjects who have taken other immunomodulatory therapies within 2 months prior to&#xD;
             Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG),&#xD;
             interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF),&#xD;
             sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha),&#xD;
             thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium&#xD;
             (Imuthiol), any locally available immune modulators, and any other therapeutic or&#xD;
             preventive HCC vaccine.&#xD;
&#xD;
          -  Subjects requiring concurrent participation in another experimental research treatment&#xD;
             study, or who received an experimental agent within four weeks prior to Study Entry.&#xD;
&#xD;
          -  Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases&#xD;
             unrelated to HCC.&#xD;
&#xD;
          -  Medical conditions such as active alcohol or substance abuse, or psychological issues&#xD;
             that in the opinion of the local investigator would interfere with adherence to the&#xD;
             requirements of this study.&#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>Aldar Bourinbaiar, MD/PhD</last_name>
    <role>Study Director</role>
    <affiliation>Immunitor LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Immunitor LLC</name>
      <address>
        <city>Ulaanbaatar</city>
        <country>Mongolia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mongolia</country>
  </location_countries>
  <link>
    <url>http://www.prweb.com/releases/2014/06/prweb11965485.htm</url>
    <description>press release concerning preliminary results</description>
  </link>
  <link>
    <url>http://doi.org/10.1186/2051-1426-3-S2-P200</url>
    <description>Tarakanovskaya, M. G., Chinburen, J., Purevsuren, G., Munkhzaya, C., Batchuluun, P., Bat-Ireedui, P., … Bourinbaiar, A. S. (2015). Immunotherapy of liver cancer with hepcortespenlisimut-L: open-label Phase II clinical study in patients with advanced HCC.</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>therapeutic vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared at study completion</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>PMCID: PMC4649454</doc_id>
      <doc_type>Abstract of 75-patient Phase II study</doc_type>
      <doc_url>http://doi.org/10.1186/2051-1426-3-S2-P200</doc_url>
      <doc_comment>http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649454/pdf/2051-1426-3-S2-P200.pdf</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT02256514
org study id: IMMV5
secondary id: IMMV5
nct id: NCT02256514
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate daily dosing of oral immunotherapy
      hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical
      intervention or with recurrent tumor after surgery.
Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline
      alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up
      thereafter. Additional endpoints will include blood biochemistry indices and safety
      monitoring.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
time frame: minimum 3 months
description: monthly check-up of AFP serum levels
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
time frame: minimum 3 months
description: Comparison of abdominal CT scans at baseline and 3 months later
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters
time frame: 3 months
description: Monthly blood biochemistry including liver function tests
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance
time frame: 3 months
description: Monthly evaluation of clinical symptoms as per ECOG performance status
arm group label: Daily oral dose of hepcortespenlisimut-L
arm group type: Experimental
description: Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study
intervention type: Biological
intervention name: Daily oral dose of hepcortespenlisimut-L
description: Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up
arm group label: Daily oral dose of hepcortespenlisimut-L
other name: V5
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aldar Bourinbaiar, MD/PhD
role: Study Director
affiliation: Immunitor LLC
facility: 
country: Mongolia
url: http://www.prweb.com/releases/2014/06/prweb11965485.htm
description: press release concerning preliminary results
url: http://doi.org/10.1186/2051-1426-3-S2-P200
description: Tarakanovskaya, M. G., Chinburen, J., Purevsuren, G., Munkhzaya, C., Batchuluun, P., Bat-Ireedui, P., … Bourinbaiar, A. S. (2015). Immunotherapy of liver cancer with hepcortespenlisimut-L: open-label Phase II clinical study in patients with advanced HCC.
responsible party type: Sponsor
mesh term: Liver Cirrhosis
sharing ipd: Yes
ipd description: Data will be shared at study completion
study doc: 