Open Label Immunotherapy Trial for Ovarian Cancer

Phase 2

• Conditions: Ovarian Cancer
• Interventions: Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens

• Registration Number: NCT03556566
• Lead Sponsor: Immunitor LLC

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-26
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-14
• Study Start: 2018-07-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
V3-OVA treatment arm	Tableted vaccine (V3-OVA) containing ovarian cancer antigens	Oral once daily pill of tableted vaccine (V3-OVA) containing ovarian cancer antigens administered for 3 months in 20 volunteers with ovarian cancer

Primary Outcome Measures

Name	Time	Method
Changes in tumor size and burden compared to baseline	Monthly for 3 months	Intravaginal ultrasonography to measure changes in tumor size and burden

Secondary Outcome Measures

Name	Time	Method
Effect on level of serum tumor markers compared to baseline	Monthly for three months	Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination

Trial Locations

Locations (1)

Immunitor LLC; 🇲🇳 Ulaanbaatar, Mongolia