Open Label Immunotherapy Trial for Ovarian Cancer

Overview

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.

Full Title of Study: “Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: V3-OVA treatment arm
    • Oral once daily pill of tableted vaccine (V3-OVA) containing ovarian cancer antigens administered for 3 months in 20 volunteers with ovarian cancer

Clinical Trial Outcome Measures

Primary Measures

  • Changes in tumor size and burden compared to baseline
    • Time Frame: Monthly for 3 months
    • Intravaginal ultrasonography to measure changes in tumor size and burden

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

Metastases to other sites

Gender Eligibility: Female

Ovarian cancer is female gynecological cancer

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Immunitor LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aldar Bourinbaiar, PhD, MD/PhD, Study Chair, Immunitor LLC
  • Overall Contact(s)
    • Galyna Kutsyna, MD, MD/PhD, +97695130306, kutsynagalyna@yahoo.com

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