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

Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; HCC
• Intervention / Treatment: Biological: Daily oral dose of hepcortespenlisimut-L

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
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mongolia
  • Ulaanbaatar, Mongolia
    • Immunitor LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: V5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline	monthly check-up of AFP serum levels	minimum 3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance	Comparison of abdominal CT scans at baseline and 3 months later	minimum 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters	Monthly blood biochemistry including liver function tests	3 months
Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance	Monthly evaluation of clinical symptoms as per ECOG performance status	3 months

Collaborators and Investigators

• Sponsor: Immunitor LLC
• Collaborators: Immunitor Inc.
• Investigators: Study Director: Aldar Bourinbaiar, MD/PhD, Immunitor LLC

Publications and helpful links

Helpful Links

• press release concerning preliminary results
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: therapeutic vaccine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: IMMV5 (Other Identifier: Immunitor LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared at study completion

Study Data/Documents

1. Abstract of 75-patient Phase II study
   Information identifier: PMCID: PMC4649454
   Information comments: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649454/pdf/2051-1426-3-S2-P200.pdf