EORTC 18071 — European Organisation for Research and Treatment of Cancer 18071

Phase 3 · 2015 · Melanoma

Design

Randomized, double-blind, placebo-controlled phase 3 trial of adjuvant ipilimumab 10 mg/kg versus placebo after complete resection of high-risk stage III melanoma.

Population

Patients with completely resected stage III cutaneous melanoma at high risk of recurrence.

Primary Endpoint

Recurrence-free survival

Key Result

Adjuvant ipilimumab improved median recurrence-free survival to 26.1 versus 17.1 months (HR 0.75; 95% CI 0.64-0.90; P=0.0013), and final analysis showed improved 5-year overall survival of 65.4% versus 54.4% (HR 0.72; 95% CI 0.58-0.88; P=0.001).

Guideline Impact

Led to FDA approval of adjuvant ipilimumab for stage III melanoma