A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection

NCT01022346 | Completed Phase 2

• 2 other identifiers: NV250252008-006946-24
• Study Type: interventional
• Target: 206
• Locations: 6 countries
• Sites: 66

Brief Summary

This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical intraepithelial neoplasia; RO5217790

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with CIN2/CIN3 associated with HPV16 single infection who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision

  Month 6

Secondary Outcomes (5)

• Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision

  Months 6

• Percentage of participants who achieved Histologic response (Defined as CIN Grade less than [<] 2), determined by evaluation of tissue derived from surgical excision

  Month 6

• Percentage of participants with viral clearance based on Roche Linear assay results

  Months 3 and 6

• Percentage of participants with immunologic response to HPV antigens

  Day 1 (predose), Days 8, 15, and 29, Months 3 and 6

• Percentage of Participants with at least one Adverse Events (AEs)

  Up to Month 30

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.

Drug: Placebo

RO5217790

EXPERIMENTAL

RO5217790 will be administered at a dose of 5\*10\^7 plaque forming unit (pfu) subcutaneously on Days 1, 8, and 15.

Drug: RO5217790

Interventions

Placebo DRUG

Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.

Placebo

RO5217790 DRUG

RO5217790 will be administered at a dose of 5\*10\^7 pfu subcutaneously on Days 1, 8, and 15.

RO5217790

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis within 2 months prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy. Entry to the trial will be allowed based on the local assessment of this criterion; however, CIN 2/3 diagnosis will have to be confirmed by the central pathologist for the purposes of analyzing the study
• Have satisfactory colposcopy, i.e. the entire acetowhite or disease area as well as the entire squamocolumnar junction visualized by colposcopy
• Have detection at screening of a single or multiple HR-HPV infection by analysis of liquid based cytology (LBC) material on the Roche Linear Array assay consistent with any of the trial strata as specified in study protocol

You may not qualify if:

• Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants
• Have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of CIN. If an endocervical curettage (ECC) is performed, and the endocervical curettings reveal CIN, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety
• Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
• Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
• Have a serious, concomitant disorder, including active systemic infection requiring treatment
• Have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration
• Have a proven or suspected immunosuppressive disorder or autoimmune disease
• Have any significant cardiac, hepatic or renal disease
• Have active viral infections including human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), cytomegalovirus (CMV), and Epstein barr virus (EBV) within 30 days of receiving study treatment. Mild viral infections such as Herpes Simplex Virus 1 (HSV-1) or common cold are not excluded

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (66)

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85015, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85724-5078, United States

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Colton, California, 92324, United States

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Los Angeles, California, 90027, United States

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Colorado Springs, Colorado, 80910, United States

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Stamford, Connecticut, 06904, United States

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Washington D.C., District of Columbia, 20010, United States

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Lake Worth, Florida, 33461, United States

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Miami, Florida, 33136, United States

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Plantation, Florida, 33324, United States

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Sarasota, Florida, 34239, United States

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South Miami, Florida, 33143, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30912, United States

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Decatur, Georgia, 30034, United States

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Marrero, Louisiana, 70072, United States

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Framingham, Massachusetts, 01702, United States

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Kansas City, Missouri, 64139, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89030, United States

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Las Vegas, Nevada, 89128, United States

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Lawrenceville, New Jersey, 08648, United States

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Brightwaters, New York, 11718, United States

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The Bronx, New York, 10461, United States

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New Bern, North Carolina, 28562, United States

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Winston-Salem, North Carolina, 27103, United States

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Englewood, Ohio, 45322, United States

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Gallipolis, Ohio, 45631, United States

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Oklahoma City, Oklahoma, 73104, United States

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West Reading, Pennsylvania, 19611, United States

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Columbia, South Carolina, 29201, United States

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Greenville, South Carolina, 29615, United States

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Myrtle Beach, South Carolina, 29572, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78705, United States

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Houston, Texas, 77004, United States

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McAllen, Texas, 78503, United States

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Sandy City, Utah, 84070, United States

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Norfolk, Virginia, 23502, United States

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Antwerp, 2020, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Tienen, 3300, Belgium

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Hus, 00029, Finland

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Kuopio, 70211, Finland

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Oulu, 90220, Finland

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Tampere, 33520, Finland

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Bordeaux, 33076, France

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Dijon, 21079, France

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Nantes, 44093, France

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Paris, 75231, France

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Reims, 51092, France

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Strasbourg, 67098, France

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San Juan, 00909-1711, Puerto Rico

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San Juan, 00935, Puerto Rico

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28942, Spain

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Bilbao, Vizcaya, 48013, Spain

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MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: December 1, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

PR (2); ES (4); US (43); BE (7); FR (6); FI (4)