Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)

Study Overview
=================
Brief Summary
-----------------
The primary purpose for this multi-center, non-interventional study is to evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician) for participants with laBCC.

Official Title
-----------------
Non-Interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (NIELS)

Conditions
-----------------
Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Drug: Vismodegib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed IaBCC (inappropriate for surgery or radiotherapy) Participant is not included in any other trial Male or female participants are included in the pregnancy prevention program Exclusion Criteria: Participants for whom treatment with Vismodegib is contraindicated according to the SmPC, which has been in effect at the time of treatment with Vismodegib, including: Hypersensitivity to the active substance or to any of the excipients Women who are pregnant or breastfeeding Women of childbearing potential who do not comply with the Vismodegib Pregnancy Prevention Programme Coadministration of St John's wort (Hypericum perforatum)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| laBCC Participants<br>Participants with laBCC who received at least one dose of Vismodegib in routine clinical practice for 32 months (between 02 Aug 2013 and 31 Mar 2016). | Drug: Vismodegib<br>* Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.<br>* Other names: ERIVEDGE;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response, Defined as the Time from the First Assessment of CR or PR until Disease Progression or Death from any Cause, Whichever Occurs First |  | From first objective response until disease progression or death from any cause, up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician |  | From date of first therapy until disease progression or death, whichever occurs first (up to 3 years) | 
| Percentage of Participants with Disease Control (CR, PR, or Stable Disease) |  | From date of first therapy until disease progression or death, whichever occurs first (up to 3 years) | 
| Percentage of Participants with Disease Reccurence, Defined as Participants who Achieve CR and later Progress |  | From date of first therapy until disease progression or death, whichever occurs first (up to 3 years) | 
| Progression-Free Survival, Evaluated According to Physician's Assessments |  | From the date of first therapy to disease progression or death from any cause, up to 3 years | 
| Overall Survival |  | From the date of the first therapy to death from any cause, up to 3 years | 
| Time to Response |  | From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years | 
| Percentage of Participants with Adverse Events |  | From Baseline up to 3 years |