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Open Label Immunotherapy Trial for Ovarian Cancer (V3-OVA)

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ClinicalTrials.gov Identifier: NCT03556566
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Immunitor LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open label Phase II study in volunteers with ovarian cancer receiving daily dose of one pill of vaccine V3-OVA
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer
Actual 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: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
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
 Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens
One pill of V3-OVA per day for three months
Other Name: V3-OVA


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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:   Ovarian cancer is female gynecological cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Metastases to other sites

Contacts and Locations
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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): NCT03556566


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

Locations
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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
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Study Chair: Aldar Bourinbaiar, PhD, MD/PhD Immunitor LLC
More Information
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Additional Information:
review article on oral vaccines  This link exits the ClinicalTrials.gov site

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Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT03556566     History of Changes
Other Study ID Numbers: V3-OVA-01
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared upon study completion in peer-reviewed publication

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

Keywords provided by Immunitor LLC:
ovary
ovarian
immunotherapy
cancer

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs