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

August 29, 2019 updated by: Immunitor LLC

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mongolia
      • Ulaanbaatar, Mongolia
        • Recruiting
        • Immunitor LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

Metastases to other sites

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • V3-OVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Monthly for 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Monthly for three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunitor LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2018

Primary Completion (ANTICIPATED)

November 30, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

May 26, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (ACTUAL)

June 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V3-OVA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe