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

Completed

Conditions

Intervention / Treatment

Drug: cemiplimab

Study Type

Observational

Enrollment (Actual)

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 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Group / Cohort

Intervention / Treatment

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

Other Names:

REGN2810
Libtayo

What is the study measuring?

Primary Outcome Measures

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

Regeneron Pharmaceuticals

Investigators

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)

June 27, 2019

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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.

CemiplimAb Survivorship Epidemiology (CASE)