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

Purpose

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.

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

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
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (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

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

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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, 20001
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, 37732
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, 33521
France

Bordeaux, France, 33076

Dijon, France, 21034

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

Barcelona, Spain, 08036

Bilbao, Spain, 48013

Madrid, Spain, 28942

Madrid, Spain, 28040

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:	May 7, 2013
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 June 17, 2013