A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
← 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
1,564actual
Sites
211
Countries
Argentina, Australia, Belgium +19
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 | 2023-01-16 | actual | When the study began enrolling |
| Primary completion | 2026-07-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-04-03 | estimated | The whole study's end, after follow-up |
| First posted | 2022-11-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-06 | 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 OFRelapse free survival (RSF)
measured Up to 5 Years
Permalink · REGN's whole pipeline · Catalyst calendar · Every registered study · What changed