NICHE-2

NCT03026140 📎

Regimen

Experimental
Nivolumab + ipilimumab (2 cycles neoadjuvant) before surgery
Control
single-arm

Population

dMMR (mismatch repair-deficient) nonmetastatic locally advanced colon cancer, stage II–III, neoadjuvant immunotherapy before curative resection.

Key finding

Timely surgery: 98% (97.5% CI 93–100); pathological response in 109/111 (98%, 95% CI 94–100); major pathological response (≤10% residual): 95%; pathological complete response (0% residual): 68%; no recurrences at median 26-month follow-up; grade 3–4 irAEs: 4%; no discontinuations.

Source: PMID 38838311

Timeline

    Guideline citations

    • NCCN Colon (p.91)