Clinical trialPhase 3Head and neck cancers

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 · 2026680 patients (analysis of 666 patients randomised by the data cut-off)

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

Study type: Clinical trial
Study name: NIVOPOST-OP (GORTEC 2018-01)
Phase: Phase 3
Design: Randomised (1:1), open-label trial in 82 centres in 6 European countries
Sample size: 680 patients (analysis of 666 patients randomised by the data cut-off)
Source: Lancet · 2026
Trial registration: NCT03576417

In plain words

In patients whose head and neck cancer had been removed by surgery but who had a high risk of it coming back, adding the immunotherapy drug nivolumab to radiotherapy and cisplatin after surgery lowered the chance of the cancer returning or of death by about a quarter. Severe side effects were somewhat more common.

Key results

HR 0.76

Disease-free survival

95% CI: 0.60 to 0.98; P=0.034; regardless of PD-L1 expression

30.3 months

Median follow-up

Analysis based on 666 patients randomised by the data cut-off date (30 April 2024)

Drugs in this study:Cisplatin (Platinol)Nivolumab (Opdivo)

Dose and schedule cards

Nivolumab + postoperative chemoradiotherapy (NIVOPOST-OP; not approved)

After complete resection of oral cavity, oropharyngeal, laryngeal or hypopharyngeal cancer with at least one high-risk feature (extracapsular extension, microscopically positive margins, 4 or more involved nodes, multiple perineural invasion); age 19 to 74 years, ECOG 0 to 1On the page “Head and neck cancers” · Resectable locally advanced (excluding nasopharynx): treatment before and after surgery

Drug	Dose	Route	Schedule
Before chemoradiotherapy
Nivolumab	240 mg	IV	One dose
Concurrent: 3 cycles
Nivolumab	360 mg	IV	Every 3 weeks
Cisplatin	100 mg/m²	IV	Every 3 weeks
Concurrent
Radiotherapy	66 Gy	External beam
Adjuvant: 6 cycles
Nivolumab	480 mg	IV	Every 4 weeks

Cycle length: 21 days during the concurrent phase; then 28 days
Duration: 1 + 3 + 6 doses of nivolumab

Overall survival data are not yet conclusive, and this use of nivolumab is not approved.

On the page “Head and neck cancers” · Resectable locally advanced (excluding nasopharynx): treatment before and after surgery

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Nivolumab + cisplatin + radiotherapy

Induction: nivolumab 240 mg IV, one dose 3 weeks before the start of chemoradiotherapy.

Concurrent: IMRT 66 Gy over 6.5 weeks + cisplatin 100 mg/m² IV on days 1, 22 and 43 of radiotherapy + nivolumab 360 mg IV on days 1, 22 and 43 (3 cycles every 3 weeks).

Adjuvant: nivolumab 480 mg IV every 4 weeks, 6 cycles.

2Cisplatin + radiotherapy

IMRT 66 Gy over 6.5 weeks + cisplatin 100 mg/m² IV on days 1, 22 and 43 of radiotherapy (3 cycles every 3 weeks).

Source of the regimen details: Abstract of the paper and ClinicalTrials.gov NCT03576417 (schedule on days 1, 22 and 43 and IMRT 66 Gy over 6.5 weeks)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients aged 19 to 74 with ECOG performance status zero or 1 and squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, who had undergone macroscopically complete surgical resection and had at least one high-risk pathological feature: extranodal (extracapsular) extension, microscopically positive margin, involvement of 4 or more neck nodes without extranodal extension, or multiple perineural invasion. Per the ClinicalTrials.gov record: pathological stage III or IV (AJCC 8th edition), radiotherapy starting 4 to 9 weeks after surgery, and ability to receive 3 cycles of cisplatin 100 mg/m² (creatinine clearance 60 mL/min or more).

Endpoints

Primary endpoint: investigator-assessed disease-free survival in the intention-to-treat population.

Safety and side effects

Treatment-related grade 4 adverse events: 10% (30 of 312) with nivolumab versus 5% (16 of 306); treatment-related deaths: 2 in each group.

Clinical significance and place in guidelines

The first treatment in about two decades to improve on postoperative cisplatin–radiotherapy in high-risk patients; overall survival data have not yet been reported.

Limitations

Open-label trial; primary endpoint assessed by the investigator; patients aged 75 and over were not enrolled; overall survival results are not reported in the abstract.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.