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

August 11, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
      • Brussel, 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
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28040
      • Madrid, Spain, 28942
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85032
      • Phoenix, Arizona, United States, 85015
      • Tucson, Arizona, United States, 85712
      • Tucson, Arizona, United States, 85724-5078
    • California
      • Colton, California, United States, 92324
      • Los Angeles, California, United States, 90027
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
    • Connecticut
      • Stamford, Connecticut, United States, 06904
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30912
      • Decatur, Georgia, United States, 30034
    • Louisiana
      • Marrero, Louisiana, United States, 70072
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
    • Missouri
      • Kansas City, Missouri, United States, 64139
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Las Vegas, Nevada, United States, 89128
      • Las Vegas, Nevada, United States, 89030
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
    • New York
      • Brightwaters, New York, United States, 11718
      • Bronx, New York, United States, 10461
    • North Carolina
      • New Bern, North Carolina, United States, 28562
      • Winston-salem, North Carolina, United States, 27103
    • Ohio
      • Englewood, Ohio, United States, 45322
      • Gallipolis, Ohio, United States, 45631
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
    • South Carolina
      • Columbia, South Carolina, United States, 29201
      • Greenville, South Carolina, United States, 29615
      • Myrtle Beach, South Carolina, United States, 29572
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Austin, Texas, United States, 78705
      • Houston, Texas, United States, 77004
      • McAllen, Texas, United States, 78503
    • Utah
      • Sandy, Utah, United States, 84070
    • Virginia
      • Norfolk, Virginia, United States, 23502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
Drug: Placebo
Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
Experimental: RO5217790
RO5217790 will be administered at a dose of 5*10^7 plaque forming unit (pfu) subcutaneously on Days 1, 8, and 15.
Drug: RO5217790
RO5217790 will be administered at a dose of 5*10^7 pfu subcutaneously on Days 1, 8, and 15.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
Time Frame: Months 6
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
Time Frame: Month 6
Month 6
Percentage of participants with viral clearance based on Roche Linear assay results
Time Frame: Months 3 and 6
Months 3 and 6
Percentage of participants with immunologic response to HPV antigens
Time Frame: Day 1 (predose), Days 8, 15, and 29, Months 3 and 6
Day 1 (predose), Days 8, 15, and 29, Months 3 and 6
Percentage of Participants with at least one Adverse Events (AEs)
Time Frame: Up to Month 30
Up to Month 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NV25025
  • 2008-006946-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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