Evaluating the effect of immunotherapy treatment in women with cervical or vulvar lesions

Purpose

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

Study Sites

LAC+USC Medical Center, USC Norris Comprehensive Cancer Center, Keck Medical Center of USC 90033

 
  • Women
Age icon
25+ years
 
 

Contact the study team

 

What's involved?

Trial length
  • 26 weeks

Number of visits
  • 15 visits

Prescription
  • All study-related drugs are covered as part of the study.

Procedures
  • Injections

  • Blood draws

  • Pelvic exams

  • Surgical excision of abnormal cells

Compensation
  • Compensation for time and travel is available for completion of study visits.

Medical cost coverage
  • All of the research-related procedures and tests are covered by the study.

Why participate?

Medical advances are impossible without volunteers.

Eligibility

Must have


  • 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

Can't have


  • 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.

Study team

Wltpzvp5suwpl7le78em
Principal Investigator
Lynda D. Roman, MD

For questions about this study, contact:

We respect your privacy!

All the information you give us is stored in a secure, password protected database. All the information that you choose to share will be kept private and confidential. Read University of Southern California's Privacy Policy here.