NCT06054555

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 633 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Detailed description

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab). All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment. The total duration of study participation for each subject will be approximately 26 months.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	ABP 206	ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
DRUG	Nivolumab	Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Timeline

• Start date: 2023-11-02
• Primary completion: 2028-01-25
• Completion: 2028-01-25
• First posted: 2023-09-26
• Last updated: 2026-01-12

Locations

180 sites across 31 countries: United States, Argentina, Bosnia and Herzegovina, Canada, Chile, Croatia, Czechia, Estonia, France, Georgia, Germany, Italy, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Moldova, Netherlands, Philippines, Portugal, Romania, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, Vietnam

Regulatory

• FDA-regulated drug study