S1801 — A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

Phase 2 · 2023 · Melanoma

Design

Randomized to 3 doses neoadjuvant pembrolizumab then surgery then adjuvant pembrolizumab vs. surgery then adjuvant pembrolizumab alone.

Population

Resectable stage IIIB-IV melanoma with clinically detectable nodal or in-transit disease.

Primary Endpoint

event-free survival (EFS)

Key Result

2-yr EFS 72% (neoadjuvant) vs 49% (adjuvant); HR for event/death 0.58 (P=0.004).

Guideline Impact

Adopted into NCCN as preferred neoadjuvant option for resectable stage III melanoma