CemiplimAb Survivorship Epidemiology

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are: To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic [nodal or distant]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic [nodal or distant]) basal cell carcinoma (BCC) in real-world clinical settings To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting To describe real-world use patterns of cemiplimab for CSCC and BCC To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage

Official Title
-----------------
Cemiplimab Survivorship Epidemiology (CASE) Study

Conditions
-----------------
Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: cemiplimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol Key Exclusion Criteria: Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up) Note: Other protocol defined Inclusion/Exclusion Criteria apply

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 |
| --- | --- |
| Group 1<br>This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC. | Drug: cemiplimab<br>* No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.<br>* Other names: Libtayo;|
| Group 2<br>This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) BCC. | Drug: cemiplimab<br>* No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.<br>* Other names: Libtayo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The rate of complete responses (CR) or partial responses (PR), as assessed by investigators | Up to 36 months | 
| Disease control rate (DCR) | Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators | Up to 36 months | 
| Duration of response (DOR) | Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment | Up to 36 months | 
| Time to response | Time from date of first admission of cemiplimab to the initial response | Up to 36 months | 
| Progression free survival (PFS) | Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first | Up to 36 months | 
| Overall Survival (OS) | Time from the date of first administration of cemiplimab to the date of death due to any cause | Up to 36 months | 
| Time to treatment failure (TTTF) | Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death | Up to 36 months | 
| Disease specific death (DSD) | Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators | Up to 36 months | 
| Number of patients with metastatic vs locally advanced cancer summarized every three weeks | Pattern of recurrence | Up to 36 months | 
| Immune related adverse events (irAEs) | Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 | Up to 36 months | 
| Infusion related reactions (IRRs) | NCI-CTCAE v5 | Up to 36 months | 
| Treatment related serious adverse reactions (SARs) |  | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locally Advanced CSCC (laCSCC), Metastatic CSCC (mCSCC), Locally Advanced BCC (laBCC), Metastatic BCC (mBCC)