NCT02864147

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

Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3) Using a Novel "Prime and Pull" Strategy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of this study are as follows: * To determine treatment efficacy defined as histologic regression to CIN 1 or less at weeks 20-24 (4 to 8 weeks after the end of imiquimod treatment) in the HPV Vaccine + Imiquimod group compared to control, * To determine treatment efficacy defined as histologic regression to CIN 1 or less at weeks 20-24 (4 to 8 weeks after the end of imiquimod treatment) in the Imiquimod group compared to control. The secondary objectives of this study are as follows: * To assess complete regression (i.e., histologic remission) at weeks 20-24 (4 to 8 weeks after the end of imiquimod treatment) in each group, * To assess HPV clearance in each group, * To assess treatment tolerability. In addition to the primary and secondary objectives of this study, there additional exploratory/correlative objectives. The exploratory/correlative objectives are as follows: * To assess T cell infiltration in post-treatment cervical biopsies and endocervical cytobrush samples, * To assess HPV16 E7 immunity in CD4/CD8 T cells.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Dysplasia

Interventions

Type	Name	Description
DRUG	9-valent HPV vaccine	All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
DRUG	Imiquimod	At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-05-24
• Completion: 2022-11-22
• First posted: 2016-08-11
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

1 site across 1 country: United States