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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01022346
First received: November 20, 2009
Last updated: November 3, 2014
Last verified: November 2014

November 20, 2009
November 3, 2014
October 2009
September 2013   (final data collection date for primary outcome measure)
Histologic resolution [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01022346 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection
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 asses s 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 pla cebo 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
  • Drug: Placebo
    0.5 mL buffer solution sc on days 1, 8 and 15
  • Drug: RO5217790
    sc in 0.5 mL buffer solution on days 1, 8 and 15
  • Experimental: A
    Intervention: Drug: RO5217790
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Finland,   France,   Puerto Rico,   Spain
 
NCT01022346
NV25025, 2008-006946-24
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP