Immunotherapy of Cervical Cancer With V3-Cervix

Last updated: August 29, 2019
Sponsor: Immunitor LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Pelvic Cancer

Vaginal Cancer

Cervical Cancer

Treatment

N/A

Clinical Study ID

NCT03550755
V3-Cervix-01
  • Ages 18-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria: metastases to other sites hysterectomy

Study Design

Total Participants: 20
Study Start date:
July 01, 2018
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Immunitor LLC

    Ulaanbaatar,
    Mongolia

    Active - Recruiting

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