MedDataX Logo

Open Label Immunotherapy Trial for Ovarian Cancer

NCT ID: NCT03556566

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ovary ovarian immunotherapy cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm, open label Phase II study in volunteers with ovarian cancer receiving daily dose of one pill of vaccine V3-OVA
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Tableted vaccine (V3-OVA) containing ovarian cancer antigens

Intervention Type BIOLOGICAL

One pill of V3-OVA per day for three months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tableted vaccine (V3-OVA) containing ovarian cancer antigens

One pill of V3-OVA per day for three months

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

V3-OVA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

Metastases to other sites

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Immunitor LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aldar Bourinbaiar, PhD, MD/PhD

Role: STUDY_CHAIR

Immunitor LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Immunitor LLC

Ulaanbaatar, , Mongolia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Mongolia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Galyna Kutsyna, MD, MD/PhD

Role: CONTACT

Phone: +97695130306

Email: [email protected]

Marina Tarakanovskaya, MD

Role: CONTACT

Phone: +97695130306

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aldar Bourinbaiar, MD

Role: primary

Marina Tarakanovskaya, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

V3-OVA-01

Identifier Type: -

Identifier Source: org_study_id