Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

• Status: Active, not recruiting
• Trial end date: 2025-12-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age

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

• Stage IIIb/C or Stage IV before complete resection

• No previous anti-cancer treatment

Exclusion Criteria:

• Ocular or uveal melanoma

• History of carcinomatosis meningitis

• History of auto-immune disease

• Treatment directed against the resected melanoma that is administrated after the surgery

Other protocol-defined inclusion/exclusion criteria apply