Last updated on January 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02864147

Contact Investigators or Research Sites near you

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Alessandro Santin, M.D.

Smilow Cancer Hospital at Yale New Haven
New Haven, CT United States
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Recruitment Status: Open


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