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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cervical Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT01022346

Run by

Hoffmann-La Roche

People needed

206

Starts

2009-08-01

Expected to finish

2013-09-01

Last updated by the study team

2016-08-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Colton, California, United States
• Study site — Los Angeles, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Stamford, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Lake Worth, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Marrero, Louisiana, United States
• Study site — Framingham, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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