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NIVOPOSTOP

Nivolumab added to cisplatin and radiotherapy versus cisplatin and radiotherapy alone after surgery for squamous cell carcinoma of the head and neck at a high risk of relapse (GORTEC 2018-01 NIVOPOST-OP)

Phase 3N = 680NCT03576417

Population
Resected locally advanced squamous cell carcinoma of the head and neck with high-risk pathological features, aged 19-74 years, ECOG performance status 0-1
Design
Open-label phase 3 trial at 82 sites in six countries. 680 participants with resected squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx and at least one high-risk pathological feature (nodal extracapsular extension, microscopically positive margins, four or more involved cervical nodes without extracapsular extension, or multiple perineural invasions) were randomised 1:1 to cisplatin and radiotherapy (66 Gy; cisplatin 100 mg per square metre every 3 weeks for 3 cycles) or to nivolumab 240 mg, then cisplatin and radiotherapy with 3 cycles of concomitant nivolumab 360 mg every 3 weeks and 6 cycles of adjuvant nivolumab 480 mg every 4 weeks. The analysis was based on 666 participants randomly assigned until the cutoff date.
Primary endpoint
DFS
Arms
  • Nivolumab, cisplatin and radiotherapy (experimental): Nivolumab with cisplatin 100 mg per square metre and radiotherapy 66 Gy, followed by adjuvant nivolumab
  • Cisplatin and radiotherapy (control): Cisplatin 100 mg per square metre every 3 weeks (3 cycles) with radiotherapy 66 Gy
People
Bourhis J, senior author Tao Y, GORTEC
DFSHR 0.76 (95% CI 0.60–0.98)
Show the numbers
Results reported for NIVOPOSTOP
EndpointAnalysisNivolumab, cisplatin and radiotherapyCisplatin and radiotherapyEffect
DFSParticipants randomly assigned until the cutoff date (N = 666)Disease-free survival as assessed by the investigator; events were relapses or deathsprimarymedian follow-up 30.3 monthsBourhis 2026——HR 0.76 (95% CI 0.60–0.98)P=0.034The abstract states the improvement was irrespective of PD-L1 expression. Medians are not given in the abstract. Treatment-related grade 4 adverse events: 30 of 312 (10%) with nivolumab versus 16 of 306 (5%); treatment-related deaths in two participants in each group.
Results reported for NIVOPOSTOP
EndpointAnalysisNivolumab, cisplatin and radiotherapyCisplatin and radiotherapyEffect
DFSParticipants randomly assigned until the cutoff date (N = 666)Disease-free survival as assessed by the investigator; events were relapses or deathsprimarymedian follow-up 30.3 monthsBourhis 2026——HR 0.76 (95% CI 0.60–0.98)P=0.034The abstract states the improvement was irrespective of PD-L1 expression. Medians are not given in the abstract. Treatment-related grade 4 adverse events: 30 of 312 (10%) with nivolumab versus 16 of 306 (5%); treatment-related deaths in two participants in each group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.760.6–0.98
Primary publication: Bourhis J, Aupérin A, Borel C, Lefebvre G, Racadot S, Geoffrois L, et al. 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. Lancet. 2026;407(10526):363-374. PubMedDOI

Appears in

Sources

  1. Bourhis J, Aupérin A, Borel C, Lefebvre G, Racadot S, Geoffrois L, et al. 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. Lancet. 2026;407(10526):363-374.

    PubMedDOI