A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
← catalyst calendarNCT06190951 · readout in 75 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
151actual
Sites
104
Countries
Australia, Austria, Canada +5
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 | 2024-09-18 | actual | When the study began enrolling |
| Primary completion | 2026-11-02 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-12-09 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-10 | 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: cemiplimab — also filed as REGN2810, Libtayo
- Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab — also filed as REGN2810, Libtayo, REGN3767
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFPathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR)
measured Up to 1 year
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