NCT05907122

A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.

Detailed description

Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab. The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma. All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment. The total duration of study participation for each subject will be approximately 13 months.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	ABP 206	ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
DRUG	FDA-licensed Nivolumab	FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
DRUG	EU-authorized Nivolumab	FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Timeline

• Start date: 2023-07-26
• Primary completion: 2025-03-26
• Completion: 2025-10-31
• First posted: 2023-06-18
• Last updated: 2026-03-27

Locations

76 sites across 22 countries: United States, Argentina, Bosnia and Herzegovina, Brazil, Chile, Croatia, Georgia, Italy, Japan, Lithuania, Malaysia, Mexico, Moldova, Netherlands, Romania, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Vietnam

Regulatory

• FDA-regulated drug study