Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo

Outcome Time Frame:

Upon occurrence

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-029

NCT ID:

NCT00636168

Start Date:

June 2008

Completion Date:

April 2015

Related Keywords:

• High Risk Stage III Melanoma
• Melanoma