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

Phase 3

Recruiting

• Conditions: Melanoma

• Registration Number: JPRN-jRCT2031230360
• Lead Sponsor: Medical Information

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-25
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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
- Other protocol-defined inclusion criteria apply

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified