A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT06848088
This observational study evaluates the long-term safety and effectiveness of fianlimab and cemiplimab in melanoma patients from cohorts 6, 15, or 16 of study R3767-ONC-1613. No drugs are administered; instead, cancer status and general health are monitored alongside routine care. Information on other treatments received post-study is also collected.
Patient Parameters
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Program Overview
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).
Eligibility Criteria
Inclusion Criteria
1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)
Key
Exclusion Criteria
None
Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Angeles Clinic and Research Institute - West Los Angeles Office | 90025 | Los Angeles | California |
| California Pacific Medical Center | 94115 | San Francisco | California |
| University of Colorado Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Henry Ford Hospital | 48202 | Detroit | Michigan |
| Cancer & Hematology Centers of Western Michigan | 49546 | Grand Rapids | Michigan |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| South Texas Oncology And Hematology | 78229 | San Antonio | Texas |
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