Open Label Immunotherapy Trial for Ovarian Cancer (V3-OVA)
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ClinicalTrials.gov Identifier: NCT03556566 |
Recruitment Status : Unknown
Verified August 2019 by Immunitor LLC.
Recruitment status was: Recruiting
First Posted : June 14, 2018
Last Update Posted : August 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
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 |

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

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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 |
Inclusion Criteria:
Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -
Exclusion Criteria:
Metastases to other sites
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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
Contact: Galyna Kutsyna, MD, MD/PhD | +97695130306 | kutsynagalyna@yahoo.com | |
Contact: Marina Tarakanovskaya, MD | +97695130306 | marinatarakanovskaya@yahoo.com |
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 |
Study Chair: | Aldar Bourinbaiar, PhD, MD/PhD | Immunitor LLC |
Responsible Party: | Immunitor LLC |
ClinicalTrials.gov Identifier: | NCT03556566 |
Other Study ID Numbers: |
V3-OVA-01 |
First Posted: | June 14, 2018 Key Record Dates |
Last Update Posted: | August 30, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data will be shared upon study completion in peer-reviewed publication |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ovary ovarian immunotherapy cancer |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |