A Phase 2 interventional study of Fianlimab+cemiplimab in Melanoma, sponsored by Regeneron Pharmaceuticals. Enrolling by invitation at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Other
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).
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 48 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key 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
Drug: Fianlimab+cemiplimab
Drug: Fianlimab+cemiplimab
No study drug administered in this observational study.
Also known as: REGN3767, REGN2810, Libtayo®
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
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Regeneron Pharmaceuticals