Spots Global Cancer Trial Database for Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)

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Trial Identification

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

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

Study ID: NCT02864147

Conditions

Cervical Intraepithelial Neoplasia

Cervical Dysplasia

Interventions

9-valent HPV vaccine

Imiquimod

Study Description

Brief 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.