A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2009 |
| End Date: | September 2013 |
A Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Safety and the Response Rate as to Histologic Resolution of 3 sc Administered Doses of RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection
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.
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.
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
We found this trial at
41
sites
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