7 / 36
EORTC 18071/CA184-029:
Study Design
Stratification factors
• Stage (IIIA vs IIIB vs IIIC 1-3 positive lymph nodes vs IIIC ≥4 positive lymph nodes)
• Regions (North America, European countries, and Australia)
Enrollment Period: June 2008 to July 2011
INDUCTION
Ipilimumab 10 mg/kg
Q3W × 4
High-risk, stage
III, completely
resected
melanoma
INDUCTION
Placebo
Q3W × 4
R
MAINTENANCE
Ipilimumab 10 mg/kg
Q12W up to 3 years
MAINTENANCE
Placebo
Q12W up to 3 years
Treatment up to a maximum of 3 years, or until disease
progression, intolerable toxicity, or withdrawal
N = 475
N = 476
Week 1
Week 12
Week 24
N = 951
Q3W = every 3 weeks; Q12W = every 12 weeks; R = randomization.
Eggermont AM et al. Lancet Oncol 2015;16:522-30