Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
← catalyst calendarSponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,546actual
Sites
210
Countries
Argentina, Australia, Austria +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-07-14 | actual | When the study began enrolling |
| Primary completion | 2026-03-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-09-16 | estimated | The whole study's end, after follow-up |
| First posted | 2022-04-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Melanoma
Interventions
- Drug: Fianlimab — also filed as REGN3767
- Drug: Cemiplimab — also filed as REGN2810, Libtayo
- Drug: Pembrolizumab — also filed as MK-3475, lambrolizumab, Keytruda
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFProgression-free survival (PFS)
measured Approximately 27 months
Publications
- PMID 41811823 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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