Melanoma Clinical Trial

CemiplimAb Survivorship Epidemiology

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 cutaneous squamous cell carcinoma (CSCC) and patients with advanced 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 HHI usage

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Melanoma

Estimated Enrollment:

500

Study ID:

NCT03836105

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 53 Locations for this study

See Locations Near You

Oncology Specialties, PC - Clearview Cancer Institute
Huntsville Alabama, 35805, United States
Dignity Health St. Joseph's Hospital and Medical Center
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
Montefiore Hospital
Bronx New York, 10461, 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
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

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

500

Study ID:

NCT03836105

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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