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

I

Immunitor

Status and phase

Unknown
Phase 2

Conditions

Ovarian Cancer

Treatments

Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03556566
V3-OVA-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No 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

-

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

V3-OVA treatment arm
Experimental group
Description:
Oral once daily pill of tableted vaccine (V3-OVA) containing ovarian cancer antigens administered for 3 months in 20 volunteers with ovarian cancer
Treatment:
Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens

Trial contacts and locations

0

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Central trial contact

Galyna Kutsyna, MD, MD/PhD; Marina Tarakanovskaya, MD

Data sourced from clinicaltrials.gov

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