A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection

Roche

Status and phase

Completed

Phase 2

Conditions

Cervical Intraepithelial Neoplasia

Treatments

Drug: Placebo

Drug: RO5217790

Study type

Interventional

Funder types

Industry

Identifiers

NCT01022346

NV25025

2008-006946-24 (EudraCT Number)

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.

Enrollment

206 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a diagnosis within 2 months prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy. Entry to the trial will be allowed based on the local assessment of this criterion; however, CIN 2/3 diagnosis will have to be confirmed by the central pathologist for the purposes of analyzing the study
Have satisfactory colposcopy, i.e. the entire acetowhite or disease area as well as the entire squamocolumnar junction visualized by colposcopy
Have detection at screening of a single or multiple HR-HPV infection by analysis of liquid based cytology (LBC) material on the Roche Linear Array assay consistent with any of the trial strata as specified in study protocol

Exclusion criteria

Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants
Have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of CIN. If an endocervical curettage (ECC) is performed, and the endocervical curettings reveal CIN, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety
Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
Have a serious, concomitant disorder, including active systemic infection requiring treatment
Have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration
Have a proven or suspected immunosuppressive disorder or autoimmune disease
Have any significant cardiac, hepatic or renal disease
Have active viral infections including human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), cytomegalovirus (CMV), and Epstein barr virus (EBV) within 30 days of receiving study treatment. Mild viral infections such as Herpes Simplex Virus 1 (HSV-1) or common cold are not excluded