Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb / c or Stage IV Melanoma (CheckMate 238)

Status: Closed to Accrual

Description

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

Eligibility Criteria

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

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

Italy, Greece, and Argentina: ≥ 18 years of age

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-238
Secondary IDs NCI-2015-00460, 2014-002351-26, s14-01680
Clinicaltrials.gov ID NCT02388906