Open Label Immunotherapy Trial for Ovarian Cancer

Ovarian Cancer Clinical Trial

— V3-OVA  

Official title:

Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03556566
• Other study ID #: V3-OVA-01
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

-

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

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

External Links

•   review article on oral vaccines