Cutaneous Squamous Cell CarcinomaCASENCT03836105
CemiplimAb Survivorship Epidemiology
An observational study of Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, run by Regeneron Pharmaceuticals at 53 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
- What is being tested?
- cemiplimab
- How many people
- 287 participants
- Where
- 53 sitesin 2 countries
- Study dates
- 27 Jun 2019to 29 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol
Who cannot join
- 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
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States51 sites
Texas Oncology-Amarillo Cancer Center
Amarillo, Texas, 79106
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Baltimore Veterans Affairs Medical Center
Baltimore, Maryland, 21201
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14203
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
University of Vermont
Burlington, Vermont, 05401
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414
Oncology Specialists of Charlotte, PA
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Texas Oncology
Dallas, Texas, 75246
University of Texas Southwestern
Dallas, Texas, 75390
Integrity Clinical Research
Delray Beach, Florida, 33745
Durham VA Medical Center
Durham, North Carolina, 27705
Regeneron Research Facility
Elizabeth, New Jersey, 07202
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
NorthShore University HealthSystem
Evanston, Illinois, 60201
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Frederick Health
Frederick, Maryland, 21702
MD Anderson Cancer Center
Houston, Texas, 77030
Oncology Specialties, PC - Clearview Cancer Institute
Huntsville, Alabama, 35805
Mayo Clinic
Jacksonville, Florida, 32224
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
University of California San Diego
La Jolla, California, 92037
Regeneron Research Facility
Largo, Florida, 33770
Optum Cancer Care
Las Vegas, Nevada, 89102
Southeast Nebraska Hematology & Oncology Consultants, PC
Lincoln, Nebraska, 68510
CARTI Cancer Center
Little Rock, Arkansas, 72205
Harbor-UCLA/LA Biomedical Research Institute
Los Angeles, California, 90502
Regional Cancer Care Associates, LLC
Manchester, Connecticut, 06040
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
Regeneron Research Facility
Miami, Florida, 33156
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Regeneron Research Facility
New York, New York, 10016
Regeneron Research Facility
New York, New York, 10032
Regeneron Research Facility
Nyack, New York, 10960
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
Oregon Health & Science University
Portland, Oregon, 97239
Reid Oncology Association
Richmond, Indiana, 47374
St. Mary's Medical Center
San Francisco, California, 94117
CHRISTUS Highland Cancer Treatment Center
Shreveport, Louisiana, 71105
Regeneron Research Facility
Stanford, California, 94063
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Hospital
The Bronx, New York, 10461
Renovatio Clinical
The Woodlands, Texas, 77380
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792
Puerto Rico2 sites
Pan-American Center for Oncology Trials, LLC
Rio Piedras, 00902
FDI Clinical Research
San Juan, 00927
About this study
Official title: Cemiplimab Survivorship Epidemiology (CASE) Study
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
- Being tested
- cemiplimab
- Keywords
- Locally Advanced CSCC (laCSCC), Metastatic CSCC (mCSCC), Locally Advanced BCC (laBCC), Metastatic BCC (mBCC)
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemiplimabDrug
Also called REGN2810, Libtayo
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC. Receives: Drug: cemiplimab | |
| Group 2 | This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) BCC. Receives: Drug: cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Measured: 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
Measured: 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
Measured: Up to 36 months
Time to response
Time from date of first admission of cemiplimab to the initial response
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 36 months
Disease specific death (DSD)
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Measured: Up to 36 months
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Pattern of recurrence
Measured: Up to 36 months
Immune related adverse events (irAEs)
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
Measured: Up to 36 months
Infusion related reactions (IRRs)
NCI-CTCAE v5
Measured: Up to 36 months
Treatment related serious adverse reactions (SARs)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start27 Jun 2019
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836105
- Sponsor's protocol ID
- R2810-ONC-1806
- Acronym
- CASE
- Status last verified
- Oct 2025
- First submitted
- 7 Feb 2019
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Publications
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.
PubMed 39797702Migden 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.
PubMed 31951149
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cemiplimab Survivorship Epidemiology (CASE) Study
- ClinicalTrials.gov ID
- NCT03836105
- Acronym / sponsor ID
- CASE / R2810-ONC-1806
- Keywords
- Locally Advanced CSCC (laCSCC), Metastatic CSCC (mCSCC), Locally Advanced BCC (laBCC), Metastatic BCC (mBCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: cemiplimabThis group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC. |
| Group 2 | – | Drug: cemiplimabThis group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) BCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 (1 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cemiplimabAlso: REGN2810, LibtayoNo 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. | Drug | Group 1, Group 2 |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 36 months
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Disease control rate (DCR)
Time frame: Up to 36 months
Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators
Duration of response (DOR)
Time frame: Up to 36 months
Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment
Time to response
Time frame: Up to 36 months
Time from date of first admission of cemiplimab to the initial response
Progression free survival (PFS)
Time frame: Up to 36 months
Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first
Overall Survival (OS)
Time frame: Up to 36 months
Time from the date of first administration of cemiplimab to the date of death due to any cause
Time to treatment failure (TTTF)
Time frame: Up to 36 months
Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death
Disease specific death (DSD)
Time frame: Up to 36 months
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Time frame: Up to 36 months
Pattern of recurrence
Immune related adverse events (irAEs)
Time frame: Up to 36 months
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
Infusion related reactions (IRRs)
Time frame: Up to 36 months
NCI-CTCAE v5
Treatment related serious adverse reactions (SARs)
Time frame: Up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Derived from this study: PubMed 39797702Park 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.
- Derived from this study: PubMed 31951149Migden 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.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceutical, Inc.
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, run by Regeneron Pharmaceuticals at 53 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 36 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.