Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This is a randomized Phase II, three arm control trial in patients with Cervical
Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3
meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study
pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed
from endocervical cytobrush samples to determine HPV status associated with the dysplasia.
Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be
randomized to one of three arms: observation only (control), imiquimod only, imiquimod +
9-valent HPV vaccine.