Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of the study are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC. |
| |
| Group 2 | This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) BCC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cemiplimab | Drug | 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. |
| 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 |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion Criteria apply
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceutical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Specialties, PC - Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Dignity Health St. Joseph's Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39797702 | Derived | Park SJ, Ellison DM, Weight R, Homsi J, Rabinowits G, Ruiz ES, Strasswimmer J, Simmons J, Panella T, Quek RG, Pouliot JF, Khushalani NI. CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma. Future Oncol. 2025 Feb;21(4):431-436. doi: 10.1080/14796694.2024.2448416. Epub 2025 Jan 11. | |
| 31951149 |
Not provided
Not provided
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | United States |
| University of California San Diego | La Jolla | California | 92037 | United States |
| Harbor-UCLA/LA Biomedical Research Institute | Los Angeles | California | 90502 | United States |
| St. Mary's Medical Center | San Francisco | California | 94117 | United States |
| Regeneron Research Facility | Stanford | California | 94063 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| The Melanoma and Skin Cancer Institute | Englewood | Colorado | 80113 | United States |
| Regional Cancer Care Associates, LLC | Manchester | Connecticut | 06040 | United States |
| Integrity Clinical Research | Delray Beach | Florida | 33745 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Regeneron Research Facility | Largo | Florida | 33770 | United States |
| Regeneron Research Facility | Miami | Florida | 33156 | United States |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital | Thomasville | Georgia | 31792 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Reid Oncology Association | Richmond | Indiana | 47374 | United States |
| CHRISTUS Highland Cancer Treatment Center | Shreveport | Louisiana | 71105 | United States |
| Baltimore Veterans Affairs Medical Center | Baltimore | Maryland | 21201 | United States |
| Frederick Health | Frederick | Maryland | 21702 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Southeast Nebraska Hematology & Oncology Consultants, PC | Lincoln | Nebraska | 68510 | United States |
| Optum Cancer Care | Las Vegas | Nevada | 89102 | United States |
| Regeneron Research Facility | Elizabeth | New Jersey | 07202 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | United States |
| Regeneron Research Facility | New York | New York | 10016 | United States |
| Regeneron Research Facility | New York | New York | 10032 | United States |
| Regeneron Research Facility | Nyack | New York | 10960 | United States |
| New York Cancer and Blood Specialists | Port Jefferson Station | New York | 11776 | United States |
| Montefiore Hospital | The Bronx | New York | 10461 | United States |
| Oncology Specialists of Charlotte, PA | Charlotte | North Carolina | 28204 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29414 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Texas Oncology-Amarillo Cancer Center | Amarillo | Texas | 79106 | United States |
| Texas Oncology | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Renovatio Clinical | The Woodlands | Texas | 77380 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| Pan-American Center for Oncology Trials, LLC | Rio Piedras | 00902 | Puerto Rico |
| FDI Clinical Research | San Juan | 00927 | Puerto Rico |
| Migden MR, Chandra S, Rabinowits G, Chen CI, Desai J, Seluzhytsky A, Sasane M, Campanelli B, Chen Z, Freeman ML, Ibrahim SF, Khushalani NI, Andria M, Ruiz E. CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. Future Oncol. 2020 Feb;16(4):11-19. doi: 10.2217/fon-2019-0762. Epub 2020 Jan 17. |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
Not provided
Not provided
Not provided