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

Primary Purpose

Ovarian Cancer

Status

Unknown status

Phase

Phase 2

Locations

Mongolia

Study Type

Interventional

Intervention

Tableted vaccine (V3-OVA) containing ovarian cancer antigens

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovary, ovarian, immunotherapy, cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Metastases to other sites

Sites / Locations

Immunitor LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V3-OVA treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in tumor size and burden compared to baseline

Intravaginal ultrasonography to measure changes in tumor size and burden

Secondary Outcome Measures

Effect on level of serum tumor markers compared to baseline

Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination

Full Information

NCT ID

NCT03556566

First Posted

May 26, 2018

Last Updated

August 29, 2019

Sponsor

Immunitor LLC

1. Study Identification

Unique Protocol Identification Number

NCT03556566

Brief Title

Open Label Immunotherapy Trial for Ovarian Cancer

Acronym

V3-OVA

Official Title

Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

November 30, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immunitor LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

ovary, ovarian, immunotherapy, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

V3-OVA treatment arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Tableted vaccine (V3-OVA) containing ovarian cancer antigens

Other Intervention Name(s)

V3-OVA

Intervention Description

One pill of V3-OVA per day for three months

Primary Outcome Measure Information:

Title

Changes in tumor size and burden compared to baseline

Description

Intravaginal ultrasonography to measure changes in tumor size and burden

Time Frame

Monthly for 3 months

Secondary Outcome Measure Information:

Title

Effect on level of serum tumor markers compared to baseline

Description

Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination

Time Frame

Monthly for three months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Ovarian cancer is female gynecological cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level - Exclusion Criteria: Metastases to other sites -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Galyna Kutsyna, MD, MD/PhD

Phone

+97695130306

kutsynagalyna@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Tarakanovskaya, MD

Phone

+97695130306

marinatarakanovskaya@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aldar Bourinbaiar, PhD, MD/PhD

Organizational Affiliation

Immunitor LLC

Official's Role

Study Chair

Facility Information:

Facility Name

Immunitor LLC

City

Ulaanbaatar

Country

Mongolia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aldar Bourinbaiar, MD

Phone

97695130306

aldar@immunitor.com

First Name & Middle Initial & Last Name & Degree

Marina Tarakanovskaya, MD

marinatarakanovskaya@yahoo.com

First Name & Middle Initial & Last Name & Degree

Galyna Kutsyna, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be shared upon study completion in peer-reviewed publication

Learn more about this trial

Open Label Immunotherapy Trial for Ovarian Cancer

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