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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03556566
Other study ID # V3-OVA-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2019

Study information

Verified date August 2019
Source Immunitor LLC
Contact Galyna Kutsyna, MD, MD/PhD
Phone +97695130306
Email kutsynagalyna@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.


Description:

Ovarian cancer (OC) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. For treatment of OC, surgical intervention, chemotherapy, as well as radiation methods are used. Despite treatment, about 70% of patients have a relapse. Many different types of immunotherapy (especially checkpoint inhibitors) of OC being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -

Exclusion Criteria:

Metastases to other sites

-

Study Design


Intervention

Biological:
Tableted vaccine (V3-OVA) containing ovarian cancer antigens
One pill of V3-OVA per day for three months

Locations

Country Name City State
Mongolia Immunitor LLC Ulaanbaatar

Sponsors (1)

Lead Sponsor Collaborator
Immunitor LLC

Country where clinical trial is conducted

Mongolia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in tumor size and burden compared to baseline Intravaginal ultrasonography to measure changes in tumor size and burden Monthly for 3 months
Secondary Effect on level of serum tumor markers compared to baseline Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination Monthly for three months
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