This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782). The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
No study drug administered in this observational study.
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Kansas Hospital
Westwood, Kansas, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
South Texas Oncology And Hematology
San Antonio, Texas, United States
Virginia Cancer Care Specialist, PC
Fairfax, Virginia, United States
...and 1 more locations
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Time frame: Up to 4 years
Progressive-Free Survival (PFS)
Time frame: Up to 4 years
Objective Response Rate (ORR)
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: Up to 4 years
Disease Control Rate (DCR)
Time frame: Up to 4 years
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4 years
Severity of SAEs
Time frame: Up to 4 years
Incidence of treatment-related AEs
Time frame: Up to 4 years
Severity of treatment-related AEs
Time frame: Up to 4 years
Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Time frame: Up to 4 years
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