A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
← catalyst calendarNCT06246916 · readout in 215 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
560estimated
Sites
111
Countries
Canada, United States
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 | 2024-09-09 | actual | When the study began enrolling |
| Primary completion | 2027-03-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-07-10 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | 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: relatlimab+nivolumab — also filed as Opdualag™
Primary outcome
what the primary-completion date above is the date OFObjective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)
measured Up to 72 months
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