Clinical trial NCT03550755: Immunotherapy of Cervical Cancer With V3-Cervix
Official title: Open Label Single Arm Phase II Immunotherapy Trial in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: cervix
uterus
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment to receive one pill of vaccine once per day for 3 months
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Changes in tumor size and burden compared to baseline
timeFrame: monthly for 3 months
Secondary outcomes:
measure: Effect on baseline tumor markers, if any
timeFrame: Monthly for three months
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
Study officials:
affiliation: Immunitor Inc.
name: Aldar Bourinbaiar, PhD, MD/PhD
role: STUDY_CHAIR
References: