Evaluating the effect of immunotherapy treatment in women with cervical or vulvar lesions
The purpose of this research study is to see how well an investigational immunotherapy regimen works in treating women with high-grade cervical dysplasia or vulvar dysplasia. Immunotherapy is a type of treatment that uses a person’s immune system to fight diseases like cancer. Dysplasia is a precancerous condition in which abnormal cell growth occurs.
Cervical dysplasia is found by a Pap test. Vulvar dysplasia is a pre-cancerous skin condition affecting the external part of the vulva. Both conditions are most often caused by exposure to the human papillomavirus (HPV) and may lead to cancer if not treated.
Keywords: cervical dysplasia, vulvar dysplasia
LAC+USC Medical Center, USC Norris Comprehensive Cancer Center, Keck Medical Center of USC 90033
All study-related drugs are covered as part of the study.
Surgical excision of abnormal cells
Compensation for time and travel is available for completion of study visits.
All of the research-related procedures and tests are covered by the study.
- Medically confirmed diagnosis of cervical intraepithelial neoplasia 3 (CIN3) or vulvar intraepithelial neoplasia (VIN3)
- Participant is in good health based upon the results of a medical history, physical exam, vital signs and blood tests
- Effective method of birth control for the duration of the study and for 1 year after
- Be pregnant or breastfeeding
- Immunodeficiency (including known positive for HIV-1, HIV-2)
- Autoimmune disease
- Active infection or other significant illness that impacts the immune system
- Clinically significant cardiovascular disease
About This Study
Cervical dysplasia affects the cells lining the cervix, the opening between the uterus and the vagina. Vulvar dysplasia affects the outer genital area in women. When needed, current treatment may include surgery to remove the abnormal cells. Especially for vulvar dysplasia, there is a high chance that the lesion will return over time and multiple surgeries would be needed. By participating in this research study, we hope to learn whether the investigational immunotherapy treatment acts as an immune booster to help eliminate the abnormal cells, target the HPV, and prevent recurrence without the use of surgery.
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