A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
256actual
Sites
76
Countries
Argentina, Bosnia and Herzegovina, Brazil +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 | 2023-07-26 | actual | When the study began enrolling |
| Primary completion | 2025-03-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-31 | actual | The whole study's end, after follow-up |
| First posted | 2023-06-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-27 | 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: ABP 206
- Drug: FDA-licensed Nivolumab — also filed as OPDIVO®
- Drug: EU-authorized Nivolumab — also filed as OPDIVO®
Primary outcomes
what the primary-completion date above is the date OFArea Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
measured Day 1 (Postdose) through Day 28
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
measured Week 17 through Week 21
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