<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/NCT02232490</url>
  </required_header>
  <id_info>
    <org_study_id>Immunitor Hepko-V5</org_study_id>
    <secondary_id>IMM05</secondary_id>
    <nct_id>NCT02232490</nct_id>
  </id_info>
  <brief_title>Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L</brief_title>
  <acronym>Hepko-V5</acronym>
  <official_title>Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunitor LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immunitor LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic&#xD;
      benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular&#xD;
      carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic&#xD;
      benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular&#xD;
      carcinoma. The results will be compared to placebo. The trial duration is 3 months and will&#xD;
      consist of one stage with baseline laboratory evaluation including AFP levels with follow-up&#xD;
      at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be&#xD;
      preformed. The clinical evaluation will be quantified according to special performance&#xD;
      questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in plasma AFP</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in plasma AFP levels at monthly intervals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CT scan</measure>
    <time_frame>3 months</time_frame>
    <description>changes in tumor size/mumber at 3 months compared to baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>adverse effects</measure>
    <time_frame>3 months</time_frame>
    <description>evaluation of adverse effects if any</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>HCC</condition>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>hepcortespenlisimut-L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>hepcortespenlisimut-L</intervention_name>
    <description>hepcortespenlisimut-L (V5) is given in experimental arm</description>
    <arm_group_label>hepcortespenlisimut-L</arm_group_label>
    <other_name>V5</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects who are at least 18 years old and are willing and capable of providing informed&#xD;
        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, and&#xD;
        AFP serum test higher or equal to 30 IU/ml.&#xD;
&#xD;
        All subjects with reproductive potential are advised to utilize effective contraception&#xD;
        throughout the course of this study.&#xD;
&#xD;
        Health score status at baseline. Agreement to participate in the study and to give at least&#xD;
        3 samples of blood for lab 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. Those&#xD;
        who met inclusion criteria can be retrospectively enrolled. Pregnant or breast-feeding&#xD;
        women are excluded.&#xD;
&#xD;
        Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry:&#xD;
        systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons,&#xD;
        interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim&#xD;
        (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin,&#xD;
        inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any&#xD;
        locally available immune modulators, and any other therapeutic or preventive HCC vaccine.&#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 that&#xD;
        in the opinion of the local investigator would interfere with adherence to the requirements&#xD;
        of this study.&#xD;
&#xD;
        -&#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</last_name>
    <role>Study Director</role>
    <affiliation>Immunitor LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aldar Bourinbaiar, MD/PhD</last_name>
    <phone>+97695130306</phone>
    <email>immunitor@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Galyna kutsyna, MD</last_name>
    <phone>9053222</phone>
    <email>kutsynagalyna@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Immunitor LLC</name>
      <address>
        <city>Ulaanbaatar</city>
        <zip>14400</zip>
        <country>Mongolia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>aldar Bourinbaiar, MD</last_name>
      <phone>97688094463</phone>
      <email>immunitor@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Aldar Bourinbaiar, MD</last_name>
      <email>aldar@immunitor.com</email>
    </contact_backup>
    <investigator>
      <last_name>Chinburen Jigjidsuren, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Immunitor LLC</name>
      <address>
        <city>Ulaanbaatar</city>
        <country>Mongolia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aldar Bourinbaiar, MD</last_name>
      <phone>97695130306</phone>
      <email>aldar@immunitor.com</email>
    </contact>
    <contact_backup>
      <last_name>Marina Tarakanovskaya, MD</last_name>
      <email>marinatarakanovskaya@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Chinburen Jigjidsuren, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mongolia</country>
  </location_countries>
  <link>
    <url>http://www.prweb.com/releases/2014/06/prweb11965485.htm</url>
    <description>Interim Phase II trial outcome</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649454/</url>
    <description>Phase II results abstract</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Immunitor LLC</investigator_affiliation>
    <investigator_full_name>Aldar Bourinbaiar</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>AFP</keyword>
  <keyword>alpha-fetoprotein</keyword>
  <keyword>cancer vaccine</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>hepatitis</keyword>
  <keyword>HCC</keyword>
  <keyword>hepatocellular carcinoma</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>liver tumor</keyword>
  <keyword>Cholangiocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>DATA TO BE SHARED WITH COLLABORATORS</ipd_description>
  </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/NCT02232490
org study id: Immunitor Hepko-V5
secondary id: IMM05
nct id: NCT02232490
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic
      benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular
      carcinoma.
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic
      benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular
      carcinoma. The results will be compared to placebo. The trial duration is 3 months and will
      consist of one stage with baseline laboratory evaluation including AFP levels with follow-up
      at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be
      preformed. The clinical evaluation will be quantified according to special performance
      questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: changes in plasma AFP
time frame: 3 months
description: Changes in plasma AFP levels at monthly intervals
measure: CT scan
time frame: 3 months
description: changes in tumor size/mumber at 3 months compared to baseline
measure: adverse effects
time frame: 3 months
description: evaluation of adverse effects if any
arm group label: hepcortespenlisimut-L
arm group type: Experimental
description: Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC
arm group label: placebo
arm group type: Placebo Comparator
description: placebo
intervention type: Biological
intervention name: hepcortespenlisimut-L
description: hepcortespenlisimut-L (V5) is given in experimental arm
arm group label: hepcortespenlisimut-L
other name: V5
intervention type: Biological
intervention name: Placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: aldar bourinbaiar
role: Study Director
affiliation: Immunitor LLC
last name: Aldar Bourinbaiar, MD/PhD
phone: +97695130306
email: immunitor@gmail.com
last name: Galyna kutsyna, MD
phone: 9053222
email: kutsynagalyna@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Mongolia
url: http://www.prweb.com/releases/2014/06/prweb11965485.htm
description: Interim Phase II trial outcome
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649454/
description: Phase II results abstract
responsible party type: Principal Investigator
investigator affiliation: Immunitor LLC
investigator full name: Aldar Bourinbaiar
investigator title: Investigator
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Neoplasms
sharing ipd: Yes
ipd description: DATA TO BE SHARED WITH COLLABORATORS