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

• Status: Not yet recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• At least 18 years of age

• Completely removed melanoma by surgery performed within 12 weeks of randomization

• Advanced Melanoma

• Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Previous anti-cancer treatment

• Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug

• Ocular or uveal melanoma or history of carcinomatosis meningitis

• History of auto-immune disease

• Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product

Other protocol-defined inclusion/exclusion criteria apply