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Basal Cell CarcinomaPhase 2VISMONEONCT02667574

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

A Phase 2 study testing ERIVEDGE in people with Basal Cell Carcinoma, run by University Hospital, Lille at 17 sites in France.

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

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
ERIVEDGE
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
17 sitesFrance
Study dates
18 Nov 2014to 15 Jul 2020
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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).
  • Written informed consent
  • Age ≥ 18 years old
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  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
  • At least one histologically confirmed lesion...
  • Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
  • Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)
  • 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
  • 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.
  • 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.).
  • 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
  • For male patients, agreement not to donate semen during the study and for 24 months after discontinuation of Vismodegib
  • Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of Vismodegib.
  • Life expectancy > 12 weeks
  • Patients covered by a Health Insurance System

Who cannot join

  • Inability or unwillingness to swallow capsules
  • Patients with BCC situated out of the head or the neck area
  • Pregnancy or lactation
  • Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
  • Chemotherapy within 4 weeks prior to enrollment
  • Participation in another clinical trial within 4 weeks prior to enrollment
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  • Radiotherapy within 6 months prior to enrolment
  • Metastatic BCC
  • Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
  • 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.
  • Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption (according to the product SmPC).
  • Patients unable or unwilling to comply with the protocol requirements
  • Patients in emergency situations
  • Patients kept in detention

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • CHU de Besançon

    Besançon, Besançon, 25030

  • Hôpital St André

    Bordeaux, Bordeaux, 33075

  • CH de Boulogne sur mer

    Boulogne-sur-Mer, Boulogne Sur Mer, 62321

  • CHU - Hôpital d'Estaing

    Clermont-Ferrand, Clermont-Ferrand, 63003

  • CHU Bocage

    Dijon, Dijon, 21079

  • Clinique de Dermatologie

    Lille, Lille, 59037

  • Hôpital de la Timone

    Marseille, Marseille, 13885

  • Hôpital Saint Eloi

    Montpellier, Montpellier, 34295

  • Hôpital Bichat

    Paris, PARIS, 75018

  • Hôpital Saint-Louis

    Paris, PARIS, 75475

  • CHU Ambroise Paré

    Paris, Paris, 92104

  • Hôpital Haut-Lévêque

    Pessac, Pessac, 33604

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, Pierre-benite, 69495

  • Hôpital Robert Debré

    Reims, Reims, 51100

  • Hôpital Pontchaillou

    Rennes, Rennes, 35033

  • Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, 54500

  • Institut Gustave Roussy

    Villejuif, Villejuif, 94805

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
ERIVEDGE
Keywords
basal cell carcinoma, surgery, stage, vismodegib
Medical subject headings
Carcinoma, Basal Cell

What participants receive

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

  • ERIVEDGEDrug

    Also called VISMODEGIB

Study groups in NCT02667574
Study groupRoleWhat they receive
open-labelOtherEnrolled 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
Receives: Drug: ERIVEDGE

What is being measured

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

  1. the change in surgery stages

    comparison of the surgery stages before and after the treatment with Vismodegib according to specific surgery stage table

    Measured: Between baseline and maximum 10 months of treatment

Secondary outcomes (7)

  1. Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib

    Measured: from 4 to 10 months of treatment

  2. Gravity index related to the surgical or functional results (global score)

    Measured: At maximum 10 months of treatment

  3. Score of the clinical benefits at BOR

    Measured: At maximum 10 months of treatment

  4. Assessment of treatment toxicity according to NCI-CTC, v4.0

    National Cancer Institute - CommonToxicity Criteria (NCT-CTC) for the recognition and grading severity of adverse effects of chemotherapy

    Measured: 2 months after the surgery and maximum 12 months after the Vismodegib initiation

  5. Quality of life assessment by Skindex-16 questionnaire

    Measured: At screening, at 3 months, at 6 months of treatment

  6. the tumor recurrence rate

    Measured: at 3 years of follow-up

  7. the cytological response by biopsy

    Measured: from 4 to 10 months of treatment

Timeline

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

  1. First posted29 Jan 2016 (estimated)
  2. Study start18 Nov 2014
  3. Primary completion15 Jul 2020
  4. Study completion15 Jul 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667574
Sponsor's protocol ID
2013_36
Other IDs
2013-004338-13
Acronym
VISMONEO
Status last verified
Sep 2022
First submitted
20 Jan 2016
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bertrand N, Guerreschi P, Basset-Seguin N, Saiag P, Dupuy A, Dalac-Rat S, Dziwniel V, Depoortere C, Duhamel A, Mortier L. Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a multicenter, open-label, phase 2 trial (VISMONEO study): Neoadjuvant Vismodegib in Locally Advanced Basal Cell Carcinoma. EClinicalMedicine. 2021 Apr 26;35:100844. doi: 10.1016/j.eclinm.2021.100844. eCollection 2021 May.

    PubMed 33997740

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ERIVEDGE in people with Basal Cell Carcinoma, run by University Hospital, Lille at 17 sites in France.

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 23 inclusion and 14 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. 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. 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?

the change in surgery stages (time frame: Between baseline and maximum 10 months of treatment). 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 NCT02667574, which also lists 1 linked publication.

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 22 Apr 2026.

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