New Protocol: Adjuvant Nivolumab with CISplatin Concurrently with Radiotherapy for Head and Neck Cancer

Adding nivolumab to cisplatin and radiotherapy significantly improved disease-free survival for high-risk resected LA-SCCHN. Nivolumab reduced locoregional relapses with a moderate increase in grade 3 and 4 adverse events, showing a favorable risk-to-benefit ratio.

Study

Randomised, open-label, phase 3 trial [GORTEC 2018-01 NIVOPOST-OP].

High-risk resected locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Nivolumab, cisplatin, and radiotherapy (n=332) vs cisplatin and radiotherapy (n=334).

Efficacy

3yr DFS: 63.1% vs 52.5% (Nivolumab vs. placebo) (HR 0.76 [0.60-0.98])

3yr Locoregional relapse: 12.9% vs 19.8% (HR 0.63 [0.42-0.94])

3yr Distant relapse: 12.6% vs 13.2%.

Safety

Grade >=3 AEs: 73% vs 68%

Grade 4 AEs: 10% vs 5%

Serious AEs: 33% vs 19%

Lancet. Published online December 22, 2025.

Bourhis J, Auperin A, Borel C Nivolumab added to cisplatin and radiotherapy versus cisplatin and radiotherapy alone after surgery for people with squamous cell carcinoma of the head and neck at a high risk of relapse (GORTEC 2018-01 NIVOPOST-OP): a randomised, open-label, phase 3 trial

http://doi.org/10.1016/S0140-6736(25)01850-1

Reviewed by Ulas D. Bayraktar, MD on Jan 21, 2026

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