Immunotherapy of Cervical Cancer With V3-Cervix

NCT03550755 | Unknown Phase 2

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

Brief Summary

The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.

Conditions

Cervical Cancer

Keywords

cervix; uterus

Outcome Measures

Primary Outcomes (1)

• Changes in tumor size and burden compared to baseline

  Intravaginal ultrasonography of lower abdomen to measure changes

  monthly for 3 months

Secondary Outcomes (1)

• Effect on baseline tumor markers, if any

  Monthly for three months

Study Arms (1)

V3-Cervix

EXPERIMENTAL

Biological: V3-Cervix V3-Cervix is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood and tumor tissue from women with cervical cancer

Biological: V3-Cervix

Interventions

V3-Cervix BIOLOGICAL

Oral tableted preparation containing hydrolyzed tumor antigens derived from peripheral blood and tumor tissue

V3-Cervix

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This particular condition, i.e., cervical cancer, is gender specific as it is found in females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of cervical cancer available baseline measurement of tumor size and burden presence of tumor markers associated with cervical cancer, i.e., CA125, beta-hCG, CEA, SCC, СА19.9 and СА27.29 -

You may not qualify if:

• metastases to other sites hysterectomy

Sponsors & Collaborators

• Immunitor LLC: lead

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Aldar Bourinbaiar, PhD, MD/PhD

  Immunitor Inc.

  STUDY CHAIR

Central Study Contacts

Galyna Kutsyna, MD, MD/PhD

CONTACT

+97695130306; kutsynagalyna@yahoo.com

Marina Tarakanovskaya, MD

CONTACT

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 group assignment to receive one pill of vaccine once per day for 3 months

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 8, 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)