Immunotherapy of Cervical Cancer With V3-Cervix

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open Label Single Arm Phase II Immunotherapy Trial in Patients With Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Biological: V3-Cervix


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment to receive one pill of vaccine once per day for 3 months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V3-Cervix<br>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<br>* Oral tableted preparation containing hydrolyzed tumor antigens derived from peripheral blood and tumor tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumor size and burden compared to baseline | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervix, uterus