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NIVOPOSTOP showed that adding the immunotherapy nivolumab to chemoradiation after surgery for high-risk head and neck cancer kept about one in ten more patients free of relapse at three years, the first improvement in post-operative treatment in two decades.
NIVOPOSTOP randomised 680 patients whose head and neck squamous cell carcinoma had been removed but showed high-risk features, extranodal extension or positive margins, to standard postoperative cisplatin chemoradiation with or without nivolumab given before, during and after it. Postoperative chemoradiation had been the standard since the Bernier and Cooper trials of 2004, and no drug had improved on it since.
Presented at the ASCO plenary session in June 2025 by Jean Bourhis for the French GORTEC group, the trial met its primary endpoint: three-year disease-free survival was 63.1 percent with nivolumab against 52.5 percent without (hazard ratio 0.76). Most patients were HPV-negative smokers with oral cavity, laryngeal or hypopharyngeal tumours, the group with the most to gain. Toxicity was as expected for a PD-1 antibody added to chemoradiation.
Together with KEYNOTE-689, which placed pembrolizumab before and after surgery, it brought immunotherapy into curative-intent treatment of head and neck cancer after several concurrent chemoradiation trials had failed, and it suggests that timing, around rather than during radiotherapy, is what matters.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
680 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 3 yearsprimary | Nivolumab + postoperative chemoradiation | - | 63.1% | 0.76 | - | - |
| Postoperative chemoradiation | - | 52.5% |
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Hypopharyngeal cancer, Oral tongue and floor of mouth cancer, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer).
Shares KEYNOTE-689, Neoadjuvant / adjuvant / perioperative, Head and neck squamous cell carcinoma, IMRT / IGRT (modern external beam).
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Cisplatin, Head and neck squamous cell carcinoma.
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Nivolumab, PD-1, Head and neck squamous cell carcinoma.
Shares KEYNOTE-689, PD-1, Head and neck squamous cell carcinoma, Immune checkpoint inhibitors.
Shares Treat the draining lymph node before removing it, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Neoadjuvant / adjuvant / perioperative, Nivolumab.
Shares Hypopharyngeal cancer, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Head and neck squamous cell carcinoma, IMRT / IGRT (modern external beam).
Shares Hypopharyngeal cancer, Chemoradiation (chemoradiotherapy, CRT), Cisplatin, Head and neck squamous cell carcinoma.