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: September 22, 2014
Last verified: September 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

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85032
Phoenix, Arizona, United States, 85015
Tucson, Arizona, United States, 85712
Tucson, Arizona, United States, 85724-5078
United States, California
Colton, California, United States, 92324
Los Angeles, California, United States, 90027
United States, Colorado
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Stamford, Connecticut, United States, 06904
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Lake Worth, Florida, United States, 33461
Miami, Florida, United States, 33136
Plantation, Florida, United States, 33324
Sarasota, Florida, United States, 34239
South Miami, Florida, United States, 33143
West Palm Beach, Florida, United States, 33409
United States, Georgia
Atlanta, Georgia, United States, 30322
Augusta, Georgia, United States, 30912
Decatur, Georgia, United States, 30034
United States, Louisiana
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Framingham, Massachusetts, United States, 01702
United States, Missouri
Kansas City, Missouri, United States, 64139
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, Nevada
Las Vegas, Nevada, United States, 89128
Las Vegas, Nevada, United States, 89030
United States, New Jersey
Lawrenceville, New Jersey, United States, 08648
United States, New York
Brightwaters, New York, United States, 11718
Bronx, New York, United States, 10461
United States, North Carolina
New Bern, North Carolina, United States, 28562
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Englewood, Ohio, United States, 45322
Gallipolis, Ohio, United States, 45631
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Columbia, South Carolina, United States, 29201
Greenville, South Carolina, United States, 29615
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Austin, Texas, United States, 78705
Houston, Texas, United States, 77004
McAllen, Texas, United States, 78503
United States, Utah
Sandy, Utah, United States, 84070
United States, Virginia
Norfolk, Virginia, United States, 23502
Belgium
Antwerpen, Belgium, 2020
Bruxelles, Belgium, 1090
Bruxelles, Belgium, 1070
Edegem, Belgium, 2650
Gent, Belgium, 9000
Leuven, Belgium, 3000
Tienen, Belgium, 3300
Finland
Hus, Finland, 00029
Kuopio, Finland, 70211
Oulu, Finland, 90220
Tampere, Finland, 33520
France
Bordeaux, France, 33076
Dijon, France, 21079
Nantes, France, 44093
Paris, France, 75231
Reims, France, 51092
Strasbourg, France, 67098
Puerto Rico
San Juan, Puerto Rico, 00935
San Juan, Puerto Rico, 00909-1711
Spain
Bilbao, Vizcaya, Spain, 48013
Barcelona, Spain, 08036
Madrid, Spain, 28040
Madrid, Spain, 28942
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: September 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014