Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)

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.

Timeline

Start

2016-07

Primary completion

2022-05-24

Completion

2022-11-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Imiquimod + 9-valent HPV Vaccine vs Observation Only (Control); p = 0.384; Fisher Exact NCT02864147 ↗

Drugs

Indications