NADINA — Neoadjuvant Nivolumab plus Ipilimumab vs Adjuvant Nivolumab in Resectable Stage III Melanoma

Phase 3 · 2024 · Melanoma

Design

Randomized to two cycles of neoadjuvant ipilimumab + nivolumab followed by surgery (with response-driven adjuvant therapy) vs surgery followed by 12 cycles of adjuvant nivolumab.

Population

Resectable, macroscopic stage III melanoma with pathologically confirmed nodal disease.

Primary Endpoint

event-free survival (EFS)

Key Result

12-mo EFS 83.7% (neoadjuvant) vs 57.2% (adjuvant) (HR 0.32); 59% of neoadjuvant patients had a major pathological response.

Guideline Impact

Resectable stage III melanoma neoadjuvant therapy