A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck

Phase 3 Active not recruiting 680 enrolled Groupe Oncologie Radiotherapie Tete et Cou Eurofins · collab For Drug Consulting · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

Timeline

Start: 2018-10-10
Primary completion: 2027-08
Completion: 2027-09

Outcome

Met primary endpoint

paper Disease-free survival was significantly improved with nivolumab, cisplatin, and radiotherapy versus cisplatin and radiotherapy alone PMID 41448222 ↗

paper HR 0·76; 95% CI 0·60-0·98; stratified log-rank test p value=0·034 PMID 41448222 ↗

Publications

Bourhis J, Auperin A, Borel C, Lefebvre G, Racadot S, Geoffrois L, Sun XS, Saada E, Cirauqui B, Rutkowski T, Henry S, Modesto A, Johnson A, Chapet S, Calderon B, Sire C, Malard O, Bainaud M, Da Silva Motta A, Thureau S, Pointreau Y, Blanchard P, Buiret G, Bozec L, Lopez S, Vanbockstael J, Bosset M, Greilsamer C, Daste A, Bruna A, N'Guyen F, Plana M, Iruarrizaga E, Temam S, Even C, Ruiz EP, Bert M, Karamouza E, Thariat J, Kazmierska J, Psyrri A, Mesia R, Tao Y. 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 Jan 24;407(10526):363-374. doi: 10.1016/S0140-6736(25)01850-1. Epub 2025 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Background	Cisplatin	Other / unclassified	100 mg/m2	Intravenous