KEYNOTE-716 — Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma

Phase 3 · Melanoma

Population

Completely resected high-risk stage IIB–IIC melanoma.

Primary Endpoint

Recurrence-free survival

Rationale

Adjuvant immunotherapy was proven in stage III melanoma, but high-risk stage II patients — a meaningful fraction of whom relapse — had no approved adjuvant option. KEYNOTE-716 tests pembrolizumab after resection of high-risk stage II disease.

What It Could Change

Extended adjuvant immunotherapy to earlier-stage melanoma; follow-up assesses distant-metastasis-free and overall survival.