Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
← catalyst calendarSponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
790actual
Sites
130
Countries
Australia, Austria, Belgium +17
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 | 2019-10-28 | actual | When the study began enrolling |
| Primary completion | 2022-06-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-30 | estimated | The whole study's end, after follow-up |
| First posted | 2019-09-23 | actual | When this record first appeared on the registry |
| Results posted | 2023-07-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-07 | 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
- Biological: Nivolumab — also filed as Opdivo
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFRecurrence Free Survival (RFS)
measured From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2022-04-28 · 3.8 MB · Prot_SAP_000.pdf
Publications
- PMID 40139004 — linked by the registry
- PMID 37845511 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · BMY's whole pipeline · Catalyst calendar · Every registered study · What changed