CheckMate 577 — Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

Phase 3 · 2021 · Esophageal Cancer, Gastroesophageal Junction Cancer

Design

Double-blind trial randomizing patients with residual disease after neoadjuvant chemoradiation and resection 2:1 to adjuvant nivolumab versus placebo.

Population

Resected stage II/III esophageal or GEJ cancer with residual pathologic disease after neoadjuvant chemoradiotherapy.

Primary Endpoint

disease-free survival (DFS)

Key Result

Median DFS 22.4 vs 11.0 months (HR 0.69), doubling disease-free survival versus placebo.

Guideline Impact

NCCN category 1 adjuvant therapy after neoadjuvant chemoradiation with residual disease