Spots Global Cancer Trial Database for CemiplimAb Survivorship Epidemiology
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Trial Identification
Brief Title: CemiplimAb Survivorship Epidemiology
Official Title: Cemiplimab Survivorship Epidemiology (CASE) Study
Study ID: NCT03836105
Interventions
Study Description
Brief 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 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncology Specialties, PC - Clearview Cancer Institute, Huntsville, Alabama, United States
Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
CARTI Cancer Center, Little Rock, Arkansas, United States
University of California San Diego, La Jolla, California, United States
Harbor-UCLA/LA Biomedical Research Institute, Los Angeles, California, United States
St. Mary's Medical Center, San Francisco, California, United States
Regeneron Research Facility, Stanford, California, United States
University of Colorado, Aurora, Colorado, United States
The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States
Regional Cancer Care Associates, LLC, Manchester, Connecticut, United States
Integrity Clinical Research, Delray Beach, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
Regeneron Research Facility, Largo, Florida, United States
Regeneron Research Facility, Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital, Thomasville, Georgia, United States
Northwestern University, Chicago, Illinois, United States
NorthShore University HealthSystem, Evanston, Illinois, United States
Reid Oncology Association, Richmond, Indiana, United States
CHRISTUS Highland Cancer Treatment Center, Shreveport, Louisiana, United States
Baltimore Veterans Affairs Medical Center, Baltimore, Maryland, United States
Frederick Health, Frederick, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Lahey Hospital & Medical Center, Burlington, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Southeast Nebraska Hematology & Oncology Consultants, PC, Lincoln, Nebraska, United States
Optum Cancer Care, Las Vegas, Nevada, United States
Regeneron Research Facility, Elizabeth, New Jersey, United States
Montefiore Hospital, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Regeneron Research Facility, New York, New York, United States
Regeneron Research Facility, New York, New York, United States
Regeneron Research Facility, Nyack, New York, United States
New York Cancer and Blood Specialists, Port Jefferson Station, New York, United States
Oncology Specialists of Charlotte, PA, Charlotte, North Carolina, United States
Durham VA Medical Center, Durham, North Carolina, United States
Asante Rogue Regional Medical Center, Medford, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
St. Luke's University Health Network, Bethlehem, Pennsylvania, United States
Clinical Research Center of the Carolinas, Charleston, South Carolina, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
Texas Oncology-Amarillo Cancer Center, Amarillo, Texas, United States
Texas Oncology, Dallas, Texas, United States
University of Texas Southwestern, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Renovatio Clinical, The Woodlands, Texas, United States
University of Vermont, Burlington, Vermont, United States
University of Virginia, Charlottesville, Virginia, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Pan-American Center for Oncology Trials, LLC, Rio Piedras, , Puerto Rico
FDI Clinical Research, San Juan, , Puerto Rico
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceutical, Inc.
Role: STUDY_DIRECTOR
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