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

NCT02667574 | Completed Phase 2 DMC

• 2 other identifiers: 2013_362013-004338-13
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma; surgery; stage; vismodegib

Outcome Measures

Primary Outcomes (1)

• the change in surgery stages

  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 Outcomes (7)

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

  from 4 to 10 months of treatment

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

  At maximum 10 months of treatment

• Score of the clinical benefits at BOR

  At maximum 10 months of treatment

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

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

• Quality of life assessment by Skindex-16 questionnaire

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

Study Arms (1)

open-label

OTHER

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

Interventions

ERIVEDGE DRUG

Also known as: VISMODEGIB

open-label

Eligibility Criteria

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

You may qualify if:

• 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
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
• At least one histologically confirmed lesion...
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Hoffmann-La Roche: collaborator

Study Sites (17)

CHU de Besançon

Besançon, Besançon, 25030, France

Location

Hôpital St André

Bordeaux, Bordeaux, 33075, France

Location

CH de Boulogne sur mer

Boulogne-sur-Mer, Boulogne Sur Mer, 62321, France

Location

CHU - Hôpital d'Estaing

Clermont-Ferrand, Clermont-Ferrand, 63003, France

Location

CHU Bocage

Dijon, Dijon, 21079, France

Location

Clinique de Dermatologie

Lille, Lille, 59037, France

Location

Hôpital de la Timone

Marseille, Marseille, 13885, France

Location

Hôpital Saint Eloi

Montpellier, Montpellier, 34295, France

Location

Hôpital Bichat

Paris, PARIS, 75018, France

Location

Hôpital Saint-Louis

Paris, PARIS, 75475, France

Location

CHU Ambroise Paré

Paris, Paris, 92104, France

Location

Hôpital Haut-Lévêque

Pessac, Pessac, 33604, France

Location

Centre hospitalier Lyon Sud

Pierre-Bénite, Pierre-benite, 69495, France

Location

Hôpital Robert Debré

Reims, Reims, 51100, France

Location

Hôpital Pontchaillou

Rennes, Rennes, 35033, France

Location

Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, 54500, France

Location

Institut Gustave Roussy

Villejuif, Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 33997740 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Laurent MORTIER, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: November 18, 2014
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: April 22, 2026

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)