An observational study in Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, sponsored by Regeneron Pharmaceuticals. Completed at 53 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by Regeneron Pharmaceuticals · Observational
The objectives of the study are:
364 studies on the registry are indexed under Carcinoma, Basal Cell; 66 are open to participants now.
This study's enrollment of 287 is above the median of 138 across 92 observational studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients in this study will include men and women ≥18 years of age who have recently initiated, or who plan to initiate treatment with commercially available cemiplimab for laCSCC/mCSCC or laBCC/mBCC in a real-world setting.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion Criteria apply
This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) CSCC.
Drug: cemiplimab
This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) BCC.
Drug: cemiplimab
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.
Also known as: REGN2810, Libtayo
Objective response rate (ORR)
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Time frame: 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
Time frame: 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
Time frame: Up to 36 months
Time to response
Time from date of first admission of cemiplimab to the initial response
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 36 months
Disease specific death (DSD)
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Time frame: Up to 36 months
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Pattern of recurrence
Time frame: Up to 36 months
Immune related adverse events (irAEs)
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
Time frame: Up to 36 months
Infusion related reactions (IRRs)
NCI-CTCAE v5
Time frame: Up to 36 months
Treatment related serious adverse reactions (SARs)
Time frame: Up to 36 months
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals