Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC) (VISMONEO)

April 17, 2026 updated by: University Hospital, Lille

Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.

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.

Detailed Description

Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg (in accordance with the product SmPC) per administration. One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance.

The trial will consist of a Screening Period (Day -28 to -1), a Treatment Period (Day 1 to BOR), one End of Treatment Visit, one Surgery Visit and 8 Safety Follow-Up Visits after the last dose of Vismodegib (+/- 5 days). Day 1 of the study will be defined as the first day a patient receives Vismodegib.

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.
55

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

  • France
    • Besançon
      • Besançon, Besançon, France, 25030
        • CHU de Besançon
    • Bordeaux
      • Bordeaux, Bordeaux, France, 33075
        • Hôpital St André
    • Boulogne Sur Mer
      • Boulogne-sur-Mer, Boulogne Sur Mer, France, 62321
        • Ch de Boulogne sur Mer
    • Clermont-Ferrand
      • Clermont-Ferrand, Clermont-Ferrand, France, 63003
        • CHU - Hôpital d'Estaing
    • Dijon
      • Dijon, Dijon, France, 21079
        • CHU Bocage
    • Lille
      • Lille, Lille, France, 59037
        • Clinique de Dermatologie
    • Marseille
      • Marseille, Marseille, France, 13885
        • Hôpital de la Timone
    • Montpellier
      • Montpellier, Montpellier, France, 34295
        • Hôpital Saint Eloi
    • PARIS
      • Paris, PARIS, France, 75018
        • Hôpital Bichat
      • Paris, PARIS, France, 75475
        • Hôpital Saint-Louis
    • Paris
      • Paris, Paris, France, 92104
        • CHU Ambroise Pare
    • Pessac
      • Pessac, Pessac, France, 33604
        • Hôpital Haut-Lévêque
    • Pierre-benite
      • Pierre-Bénite, Pierre-benite, France, 69495
        • Centre Hospitalier Lyon Sud
    • Reims
      • Reims, Reims, France, 51100
        • Hôpital Robert Debré
    • Rennes
      • Rennes, Rennes, France, 35033
        • Hopital Pontchaillou
    • Vandoeuvre LES Nancy
      • Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, France, 54500
        • Hopitaux de Brabois
    • Villejuif
      • Villejuif, Villejuif, France, 94805
        • Institut Gustave Roussy

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

Description

Inclusion Criteria:

  1. Patients with BCC, which surgery stage is A, B or C (cf. Appendix 3: Definition of surgery stages), with a diameter ≥ 3cm in zones at intermediate risk of tumor recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor recurrence. According to the HAS recommendations, two zones are taken into consideration:

    • Zones at intermediate risk of tumor recurrence: forehead, cheek, chin, neck and scalp
    • Zones at higher risk of tumor recurrence: nose and periorificial sites of the cephalic extremity
  2. The decision to include the patient in this study should be taken during the Pluridisciplinary Committee Meeting (RCP). During this RCP, the radiotherapy should be considered as an inadequate treatment. (If the radiotherapist is absent during the meeting, his opinion should be documented in the patient's medical record).
  3. Written informed consent
  4. Age ≥ 18 years old
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
  6. At least one histologically confirmed lesion...
  7. Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
  8. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)

  9. Adequate organ function, as evidenced by the following laboratory results:

    • Hemoglobin > 8.5 g/dL
    • Granulocyte count ≥ 1000/μL
    • Platelet count ≥ 75,000/μL
    • Aspartate transaminase (AST ) and alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome
  10. Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
  11. Women of childbearing potential must use one highly-effective method of contraception and one barrier method of contraception during treatment and for 24 months after the final dose. Highly-effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, or intra-uterine devices; refer to Appendix 8 for more details). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, and postovulation methods] and withdrawal are not acceptable methods of contraception.).
  12. For male patients with female partners of childbearing potential, agreement top use a condom with spermicide, even after vasectomy, during sexual intercourse with partners while being treated with Vismodegib and for two months after completion of study treatment
  13. For male patients, agreement not to donate semen during the study and for 24 months after discontinuation of Vismodegib
  14. Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of Vismodegib.
  15. Life expectancy > 12 weeks
  16. Patients covered by a Health Insurance System

Exclusion Criteria:

  1. Inability or unwillingness to swallow capsules
  2. Patients with BCC situated out of the head or the neck area
  3. Pregnancy or lactation
  4. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
  5. Chemotherapy within 4 weeks prior to enrollment
  6. Participation in another clinical trial within 4 weeks prior to enrollment
  7. Radiotherapy within 6 months prior to enrolment
  8. Metastatic BCC
  9. Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
  10. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk from treatment complications.
  11. Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption (according to the product SmPC).
  12. Patients unable or unwilling to comply with the protocol requirements
  13. Patients in emergency situations
  14. Patients kept in detention

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: open-label
Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg per administration (in accordance with the product SmPC). One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance
Drug: ERIVEDGE
Other Names:
  • VISMODEGIB

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
Measure Description
Time Frame
the change in surgery stages
Time Frame: Between baseline and maximum 10 months of treatment
comparison of the surgery stages before and after the treatment with Vismodegib according to specific surgery stage table
Between baseline and maximum 10 months of treatment

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
Measure Description
Time Frame
Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib
Time Frame: from 4 to 10 months of treatment
from 4 to 10 months of treatment
Gravity index related to the surgical or functional results (global score)
Time Frame: At maximum 10 months of treatment
At maximum 10 months of treatment
Score of the clinical benefits at BOR
Time Frame: At maximum 10 months of treatment
At maximum 10 months of treatment
Assessment of treatment toxicity according to NCI-CTC, v4.0
Time Frame: 2 months after the surgery and maximum 12 months after the Vismodegib initiation
National Cancer Institute - CommonToxicity Criteria (NCT-CTC) for the recognition and grading severity of adverse effects of chemotherapy
2 months after the surgery and maximum 12 months after the Vismodegib initiation
Quality of life assessment by Skindex-16 questionnaire
Time Frame: At screening, at 3 months, at 6 months of treatment
At screening, at 3 months, at 6 months of treatment
the tumor recurrence rate
Time Frame: at 3 years of follow-up
at 3 years of follow-up
the cytological response by biopsy
Time Frame: from 4 to 10 months of treatment
from 4 to 10 months of treatment

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.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent MORTIER, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
November 18, 2014

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.
July 15, 2020

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.
July 15, 2020

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).
January 20, 2016

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.
January 26, 2016

First Posted (Estimated)

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.
January 29, 2016

Study Record Updates

Last Update Posted (Actual)

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.
April 22, 2026

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.
April 17, 2026

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.
September 1, 2022

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.
  • 2013_36
  • 2013-004338-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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