CemiplimAb Survivorship Epidemiology (CASE)

October 13, 2025 updated by: Regeneron Pharmaceuticals

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00902
        • Pan-American Center for Oncology Trials, LLC
      • San Juan, Puerto Rico, 00927
        • FDI Clinical Research
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Oncology Specialties, PC - Clearview Cancer Institute
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health St. Joseph's Hospital and Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • Los Angeles, California, United States, 90502
        • Harbor-UCLA/LA Biomedical Research Institute
      • San Francisco, California, United States, 94117
        • St. Mary's Medical Center
      • Stanford, California, United States, 94063
        • Regeneron Research Facility
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Englewood, Colorado, United States, 80113
        • The Melanoma and Skin Cancer Institute
    • Connecticut
      • Manchester, Connecticut, United States, 06040
        • Regional Cancer Care Associates, LLC
    • Florida
      • Delray Beach, Florida, United States, 33745
        • Integrity Clinical Research
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Largo, Florida, United States, 33770
        • Regeneron Research Facility
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute at Baptist Health, Inc.
      • Miami, Florida, United States, 33156
        • Regeneron Research Facility
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Reid Oncology Association
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Christus Highland Cancer Treatment Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore Veterans Affairs Medical Center
      • Frederick, Maryland, United States, 21702
        • Frederick Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Hematology & Oncology Consultants, PC
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Optum Cancer Care
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Regeneron Research Facility
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10016
        • Regeneron Research Facility
      • New York, New York, United States, 10032
        • Regeneron Research Facility
      • Nyack, New York, United States, 10960
        • Regeneron Research Facility
      • Port Jefferson Station, New York, United States, 11776
        • New York Cancer and Blood Specialists
      • The Bronx, New York, United States, 10461
        • Montefiore Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Oncology Specialists of Charlotte, PA
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
    • Oregon
      • Medford, Oregon, United States, 97504
        • Asante Rogue Regional Medical Center
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology-Amarillo Cancer Center
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Dallas, Texas, United States, 75246
        • Texas Oncology
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC.
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.
Other Names:
  • REGN2810
  • Libtayo
Group 2
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.
Other Names:
  • REGN2810
  • Libtayo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 36 months
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Up to 36 months
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
Up to 36 months
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
Up to 36 months
Time to response
Time Frame: Up to 36 months
Time from date of first admission of cemiplimab to the initial response
Up to 36 months
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
Up to 36 months
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
Up to 36 months
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
Up to 36 months
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
Up to 36 months
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Time Frame: Up to 36 months
Pattern of recurrence
Up to 36 months
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
Up to 36 months
Infusion related reactions (IRRs)
Time Frame: Up to 36 months
NCI-CTCAE v5
Up to 36 months
Treatment related serious adverse reactions (SARs)
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceutical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R2810-ONC-1806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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