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Cervical Intraepithelial NeoplasiaPhase 2NCT01022346

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

A Phase 2 study testing RO5217790 in people with Cervical Intraepithelial Neoplasia, run by Hoffmann-La Roche at 66 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
RO5217790
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
66 sitesin 6 countries
Study dates
Aug 2009to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

66 sites in 6 countries.

66 sites in 6 countries

United States43 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Austin, Texas, 78705

  • Study site

    Brightwaters, New York, 11718

  • Study site

    Colorado Springs, Colorado, 80910

  • Study site

    Colton, California, 92324

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Decatur, Georgia, 30034

  • Study site

    Englewood, Ohio, 45322

  • Study site

    Framingham, Massachusetts, 01702

  • Study site

    Gallipolis, Ohio, 45631

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Houston, Texas, 77004

  • Study site

    Kansas City, Missouri, 64139

  • Study site

    Lake Worth, Florida, 33461

  • Study site

    Las Vegas, Nevada, 89030

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Los Angeles, California, 90027

  • Study site

    Marrero, Louisiana, 70072

  • Study site

    McAllen, Texas, 78503

  • Study site

    Miami, Florida, 33136

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Phoenix, Arizona, 85015

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Plantation, Florida, 33324

  • Study site

    Sandy City, Utah, 84070

  • Study site

    Sarasota, Florida, 34239

  • Study site

    South Miami, Florida, 33143

  • Study site

    Stamford, Connecticut, 06904

  • Study site

    The Bronx, New York, 10461

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tucson, Arizona, 85724-5078

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    West Reading, Pennsylvania, 19611

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Belgium7 sites

  • Study site

    Antwerp, 2020

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1090

  • Study site

    Edegem, 2650

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

  • Study site

    Tienen, 3300

Other trials in Belgium

France6 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Dijon, 21079

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75231

  • Study site

    Reims, 51092

  • Study site

    Strasbourg, 67098

Other trials in France

Finland4 sites

  • Study site

    Hus, 00029

  • Study site

    Kuopio, 70211

  • Study site

    Oulu, 90220

  • Study site

    Tampere, 33520

Other trials in Finland

Spain4 sites

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Bilbao, Vizcaya, 48013

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28942

Other trials in Spain

Puerto Rico2 sites

  • Study site

    San Juan, 00909-1711

  • Study site

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Placebo, RO5217790
Keywords
Cervical intraepithelial neoplasia, RO5217790
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • RO5217790Drug

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

Study groups in NCT01022346
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
Receives: Drug: Placebo
RO5217790ExperimentalRO5217790 will be administered at a dose of 5*10^7 plaque forming unit (pfu) subcutaneously on Days 1, 8, and 15.
Receives: Drug: RO5217790

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month 6

Secondary outcomes (5)

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

    Measured: Months 6

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

    Measured: Month 6

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

    Measured: Months 3 and 6

  4. Percentage of participants with immunologic response to HPV antigens

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

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

    Measured: Up to Month 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01022346
Sponsor's protocol ID
NV25025
Other IDs
2008-006946-24, 2008
Status last verified
Aug 2016
First submitted
20 Nov 2009
Last updated
15 Aug 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO5217790 in people with Cervical Intraepithelial Neoplasia, run by Hoffmann-La Roche at 66 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Belgium, France, Finland, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01022346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.

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