Immunotherapy of Cervical Cancer With V3-Cervix (V3-Cervix)
August 29, 2019 updated by: Immunitor LLC
Open Label Single Arm Phase II Immunotherapy Trial in Patients With Cervical Cancer
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ulaanbaatar, Mongolia
- Recruiting
- Immunitor LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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
|
Oral tableted preparation containing hydrolyzed tumor antigens derived from peripheral blood and tumor tissue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in tumor size and burden compared to baseline
Time Frame: monthly for 3 months
|
Intravaginal ultrasonography of lower abdomen to measure changes
|
monthly for 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect on baseline tumor markers, if any
Time Frame: Monthly for three months
|
Change in serum levels of a panel of tumor markers such as CA125, beta-hCG, CEA, SCC, СА19.9 and СА27.29 compared to baseline
|
Monthly for three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aldar Bourinbaiar, PhD, MD/PhD, Immunitor Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2018
Primary Completion (ANTICIPATED)
November 30, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
May 26, 2018
First Submitted That Met QC Criteria
May 26, 2018
First Posted (ACTUAL)
June 8, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 30, 2019
Last Update Submitted That Met QC Criteria
August 29, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V3-Cervix-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be available upon study conclusion
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.