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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 30, 2019
Sponsor:
Information provided by (Responsible Party):
Immunitor LLC

Tracking Information
First Submitted Date  ICMJE May 26, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Immunotherapy Trial for Ovarian Cancer
Official Title  ICMJE Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens
One pill of V3-OVA per day for three months
Other Name: V3-OVA
Study Arms  ICMJE 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
Intervention: Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Metastases to other sites

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Ovarian cancer is female gynecological cancer
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galyna Kutsyna, MD, MD/PhD +97695130306 kutsynagalyna@yahoo.com
Contact: Marina Tarakanovskaya, MD +97695130306 marinatarakanovskaya@yahoo.com
Listed Location Countries  ICMJE Mongolia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556566
Other Study ID Numbers  ICMJE V3-OVA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be shared upon study completion in peer-reviewed publication
Responsible Party Immunitor LLC
Study Sponsor  ICMJE Immunitor LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Aldar Bourinbaiar, PhD, MD/PhD Immunitor LLC
PRS Account Immunitor LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP