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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
  Purpose

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.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Drug: Placebo
Drug: RO5217790
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Histologic resolution [ Time Frame: at month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 209
Study Start Date: October 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO5217790
sc in 0.5 mL buffer solution on days 1, 8 and 15
Placebo Comparator: B Drug: Placebo
0.5 mL buffer solution sc on days 1, 8 and 15

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022346

  Show 66 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01022346     History of Changes
Other Study ID Numbers: NV25025, 2008-006946-24
Study First Received: November 20, 2009
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014