A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
← catalyst calendarSponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With Halozyme Therapeutics.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
579actual
Sites
149
Countries
Australia, Austria, Belgium +16
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 | 2023-03-06 | actual | When the study began enrolling |
| Primary completion | 2025-08-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-18 | estimated | The whole study's end, after follow-up |
| First posted | 2022-11-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-03 | 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: Nivolumab + Relatlimab — also filed as BMS-986213, Opdualag
- Drug: rHuPH20
Primary outcomes
what the primary-completion date above is the date OFTime-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab
measured Up to 28 days
Trough serum concentration at steady state (Cminss) of Nivolumab
measured Up to 4 months
Cavgd28 of Relatlimab
measured Up to 28 days
Cminss of Relatlimab
measured Up to 4 months
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