Open Label Immunotherapy Trial for Ovarian Cancer

NCT03556566 | Unknown Phase 2

• 1 other identifier: V3-OVA-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovary; ovarian; immunotherapy; cancer

Outcome Measures

Primary Outcomes (1)

• Changes in tumor size and burden compared to baseline

  Intravaginal ultrasonography to measure changes in tumor size and burden

  Monthly for 3 months

Secondary Outcomes (1)

• Effect on level of serum tumor markers compared to baseline

  Monthly for three months

Study Arms (1)

V3-OVA treatment arm

EXPERIMENTAL

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

Interventions

Tableted vaccine (V3-OVA) containing ovarian cancer antigens BIOLOGICAL

One pill of V3-OVA per day for three months

Also known as: V3-OVA

V3-OVA treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Ovarian cancer is female gynecological cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Metastases to other sites

Sponsors & Collaborators

• Immunitor LLC: lead

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Aldar Bourinbaiar, PhD, MD/PhD

  Immunitor LLC

  STUDY CHAIR

Central Study Contacts

Galyna Kutsyna, MD, MD/PhD

CONTACT

+97695130306; kutsynagalyna@yahoo.com

Marina Tarakanovskaya, MD

CONTACT

+97695130306; marinatarakanovskaya@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open label Phase II study in volunteers with ovarian cancer receiving daily dose of one pill of vaccine V3-OVA

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 14, 2018
• Study Start: July 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)