A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection

• Viral clearance by Roche HPV genomic testing [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
• Immunological response to HPV antigens [ Time Frame: after treatment and at intervals during follow-up ] [ Designated as safety issue: No ]
• Incidence of adverse events (AEs) [ Time Frame: Day 1 to Month 6, and at intervals during the 2 years of follow-up ] [ Designated as safety issue: No ]
• Abnormal laboratory values [ Time Frame: Day 1 to Month 6, and at intervals during the 2 years of follow-up ] [ Designated as safety issue: No ]

• Viral clearance by Roche HPV genomic testing [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
• Immunological response to HPV antigens [ Time Frame: after treatment and at intervals during follow-up ] [ Designated as safety issue: No ]
• Safety and tolerability: adverse events, laboratory parameters [ Time Frame: day 1 to month 6, and at intervals during the 2 years of follow-up ] [ Designated as safety issue: No ]

This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in patients with high grade cervical intraepithelial neoplasia associated with high risk HPV infection. Patients will be randomized to receive 3 sc injections of either placebo or RO5217790 on days 1, 8 and 15. Histologic and viral assessments will be made at baseline, at month 3 and 6, and every 6 months thereafter for an overall of 2.5 years. Target sample size is 200 patients.

• Drug: RO5217790
  sc in 0.5 mL buffer solution on days 1, 8 and 15
• Drug: Placebo
  0.5 mL buffer solution sc on days 1, 8 and 15

• Experimental: A
  Intervention: Drug: RO5217790
• Placebo Comparator: B
  Intervention: Drug: Placebo

Inclusion Criteria:

• females >/= 18 years of age
• diagnosis of CIN 2/3 within 2 months prior to study entry confirmed by colposcopy-directed punch biopsy
• patients must have at least 1 quadrant of residual CIN 2/3 disease remaining after biopsy
• single or multiple HR-HPV infection at screening by analysis of liquid based cytology material by Roche HPV genomic testing

Exclusion Criteria:

• colposcopically visible CIN 2/3 disease extending over more than 2 quadrants
• previous excisional or ablative surgical treatment for CIN
• any anatomical condition of the cervix that would interfere with a complete evaluation of the transformation zone and surveillance of CIN
• vulvar(VIN) or vaginal (VAIN) intraepithelial neoplasia
• atypical endometrial or glandular cells or evidence of carcinoma on biopsy
• proven or suspected immunosuppressive disorder or autoimmune disease