{"entity":{"id":"nivopostop","kind":"trial","name":"NIVOPOSTOP (GORTEC 2018-01)","aka":[],"tldr":"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.","summary":"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.\n\nPresented 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.\n\nTogether 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.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03576417","url":"https://clinicaltrials.gov/study/NCT03576417"}],"tags":[],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":["pd1"],"drugs":["nivolumab","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","neoadjuvant-adjuvant","efs"],"trials":["keynote-689"],"people":["jean-bourhis"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03576417","phase":"3","setting":"Resected locally advanced head and neck squamous cell carcinoma at high risk of relapse (extranodal extension or positive margins): nivolumab before and during postoperative cisplatin chemoradiation, then nivolumab alone, versus chemoradiation alone","sponsor":"GORTEC","result":"Three-year disease-free survival 63.1% vs 52.5% (hazard ratio 0.76).","yearReported":2025,"enrolled":680,"outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Nivolumab + postoperative chemoradiation","value":63.1},{"name":"Postoperative chemoradiation","value":52.5}],"hr":0.76}],"replication":"KEYNOTE-689 (perioperative pembrolizumab) is the concordant trial; the concurrent chemoradiation trials JAVELIN Head and Neck 100 and KEYNOTE-412 were negative, so the benefit appears to depend on when the antibody is given."},"route":"/trials/nivopostop/","neighbours":{"cancer":[{"id":"buccal-mucosa-cancer","kind":"cancer","name":"Buccal mucosa and gingivobuccal cancer (oral cancer in India)","route":"/cancers/buccal-mucosa-cancer/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"hypopharyngeal-cancer","kind":"cancer","name":"Hypopharyngeal cancer","route":"/cancers/hypopharyngeal-cancer/"},{"id":"oral-tongue-cancer","kind":"cancer","name":"Oral tongue and floor of mouth cancer","route":"/cancers/oral-tongue-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"},{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"id":"keynote-689","kind":"trial","name":"KEYNOTE-689","route":"/trials/keynote-689/"}],"person":[{"id":"jean-bourhis","kind":"person","name":"Jean Bourhis","route":"/people/jean-bourhis/"}]}}