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Immunotherapy of Cervical Cancer With V3-Cervix (V3-Cervix)

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ClinicalTrials.gov Identifier: NCT03550755
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Immunitor LLC

Brief Summary:
The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.

Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: V3-Cervix Phase 2

Detailed Description:
Cervical cancer (CC) is a malignant neoplasm that occurs in the cervix. Histologically, there are two main types: adenocarcinoma and squamous cell carcinoma. Cervical cancer is most common in middle-aged women (35-55 years of age), in 20% of cases it is found over the age of 65 years. Cancer of the body and cervix are the most common type of malignant tumor of female genital organs. It is believed that human papillomavirus (HPV) is the main risk factor causing cervical cancer. Cervical cancer combines surgical treatment, radiotherapy and chemotherapy. Current immunotherapies did not show much success. The prognosis depends on the stage of the disease: 5-year survival rate at the first stage is 78.1%, at the second stage - 57%, at the third - 31%, at the fourth - 7.8%. There is no specific cervical cancer marker, usually a panel of markers is used including CA125, beta-hCG, CEA, SCC, CA19.9 and CA27.29. The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment to receive one pill of vaccine once per day for 3 months
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Open Label Single Arm Phase II Immunotherapy Trial in Patients With Cervical Cancer
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: V3-Cervix
Biological: V3-Cervix V3-Cervix is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood and tumor tissue from women with cervical cancer
Biological: V3-Cervix
Oral tableted preparation containing hydrolyzed tumor antigens derived from peripheral blood and tumor tissue




Primary Outcome Measures :
  1. Changes in tumor size and burden compared to baseline [ Time Frame: monthly for 3 months ]
    Intravaginal ultrasonography of lower abdomen to measure changes


Secondary Outcome Measures :
  1. Effect on baseline tumor markers, if any [ Time Frame: Monthly for three months ]
    Change in serum levels of a panel of tumor markers such as CA125, beta-hCG, CEA, SCC, СА19.9 and СА27.29 compared to baseline



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This particular condition, i.e., cervical cancer, is gender specific as it is found in females only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

confirmed diagnosis of cervical cancer available baseline measurement of tumor size and burden presence of tumor markers associated with cervical cancer, i.e., CA125, beta-hCG, CEA, SCC, СА19.9 and СА27.29 -

Exclusion Criteria:

metastases to other sites hysterectomy


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): NCT03550755


Contacts
Contact: Galyna Kutsyna, MD, MD/PhD +97695130306 kutsynagalyna@yahoo.com
Contact: Marina Tarakanovskaya, MD

Locations
Mongolia
Immunitor LLC Recruiting
Ulaanbaatar, Mongolia
Contact: Aldar Bourinbaiar, MD    97695130306    aldar@immunitor.com   
Contact: Marina Tarakanovskaya, MD       marinatarakanovskaya@yahoo.com   
Principal Investigator: Galyna Kutsyna, MD         
Sponsors and Collaborators
Immunitor LLC
Investigators
Study Chair: Aldar Bourinbaiar, PhD, MD/PhD Immunitor Inc.

Additional Information:
Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT03550755     History of Changes
Other Study ID Numbers: V3-Cervix-01
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available upon study conclusion

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunitor LLC:
cervix
uterus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female