A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
100actual
Sites
31
Countries
Chile, Greece, Italy +2
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 | 2023-11-06 | actual | When the study began enrolling |
| Primary completion | 2025-04-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-26 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-26 | actual | When this record first appeared on the registry |
| Results posted | 2026-04-09 | actual | 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: relatlimab+nivolumab — also filed as BMS-986213, Opdualag
- Drug: relatlimab+nivolumab+rHuPH20
- Drug: nivolumab — also filed as BMS-936558, Opdivo
- Drug: nivolumab+rHuPH20 — also filed as BMS-986298
Primary outcome
what the primary-completion date above is the date OFPercentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose
measured Cycle 4 Day 1 (each cycle consist of 4 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2024-05-24 · 6.4 MB · Prot_SAP_000.pdf
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