MedDataX Logo

Immunotherapy of Cervical Cancer With V3-Cervix

NCT ID: NCT03550755

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.

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.

Detailed Description

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

Cervical cancer (CC) is a malignant neoplasm that occurs in the cervix. Histologically, there are two main types: adenocarcinoma and squamous cell carcinoma. Cervical cancer is most common in middle-aged women (35-55 years of age), in 20% of cases it is found over the age of 65 years. Cancer of the body and cervix are the most common type of malignant tumor of female genital organs. It is believed that human papillomavirus (HPV) is the main risk factor causing cervical cancer. Cervical cancer combines surgical treatment, radiotherapy and chemotherapy. Current immunotherapies did not show much success. The prognosis depends on the stage of the disease: 5-year survival rate at the first stage is 78.1%, at the second stage - 57%, at the third - 31%, at the fourth - 7.8%. There is no specific cervical cancer marker, usually a panel of markers is used including CA125, beta-hCG, CEA, SCC, CA19.9 and CA27.29. 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

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

Cervical Cancer

Keywords

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

cervix uterus

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

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

Group Type EXPERIMENTAL

V3-Cervix

Intervention Type BIOLOGICAL

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

Interventions

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

V3-Cervix

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

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 -

Exclusion Criteria

metastases to other sites hysterectomy

\-
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 Inc.

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

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-Cervix-01

Identifier Type: -

Identifier Source: org_study_id