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Open Label Trial of Immunotherapy for Advanced Liver Cancer (HCC)

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ClinicalTrials.gov Identifier: NCT02256514
Recruitment Status : Enrolling by invitation
First Posted : October 3, 2014
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Immunitor Inc.
Information provided by (Responsible Party):
Immunitor LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HCC Liver Cirrhosis Biological: Daily oral dose of hepcortespenlisimut-L Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
Actual Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daily oral dose of hepcortespenlisimut-L
Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study
Biological: Daily oral dose of hepcortespenlisimut-L
Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up
Other Name: V5




Primary Outcome Measures :
  1. Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline [ Time Frame: minimum 3 months ]
    monthly check-up of AFP serum levels

  2. Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance [ Time Frame: minimum 3 months ]
    Comparison of abdominal CT scans at baseline and 3 months later


Secondary Outcome Measures :
  1. Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters [ Time Frame: 3 months ]
    Monthly blood biochemistry including liver function tests

  2. Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance [ Time Frame: 3 months ]
    Monthly evaluation of clinical symptoms as per ECOG performance status



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
  • HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan, and AFP serum test higher or equal to 30 IU/ml.
  • All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
  • Health score status at baseline.
  • Agreement to participate in the study and to give at least 3 samples of blood for lab tests.
  • Readily available home or o other address where patient can be found.

Exclusion Criteria:

  • Subjects who might have already taken V5 in prior trials and have no baseline data.
  • Those who met inclusion criteria can be retrospectively enrolled.
  • Pregnant or breast-feeding women are excluded.
  • Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any locally available immune modulators, and any other therapeutic or preventive HCC vaccine.
  • Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry.
  • Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to HCC.
  • Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256514


Locations
Mongolia
Immunitor LLC
Ulaanbaatar, Mongolia
Sponsors and Collaborators
Immunitor LLC
Immunitor Inc.
Investigators
Study Director: Aldar Bourinbaiar, MD/PhD Immunitor LLC

Additional Information:
Study Data/Documents: Abstract of 75-patient Phase II study  This link exits the ClinicalTrials.gov site
Identifier: PMCID: PMC4649454
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649454/pdf/2051-1426-3-S2-P200.pdf

Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT02256514     History of Changes
Other Study ID Numbers: IMMV5
IMMV5 ( Other Identifier: Immunitor LLC )
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared at study completion

Keywords provided by Immunitor LLC:
therapeutic vaccine

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases