biostudies-literatureChaudhary RNational Cancer Institute (NCI)Florida Department of Health (DOH)NIDCR NIH HHSNational Institute of Dental and Craniofacial Research (NIDR)National Cancer InstituteNCI NIH HHSNational Institute of Dental and Craniofacial ResearchFlorida Department of Health501-515https://www.ebi.ac.uk/biostudies/studies/S-EPMC12667737biostudies-literatureUnknown32(3)<h4>Purpose</h4>We report long-term survival and comprehensive molecular biomarker analyses of a phase II trial evaluating the combination of cetuximab and nivolumab in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).<h4>Patients and methods</h4>The long-term follow-up data were obtained from a phase II trial (NCT03370276). Archived tumors and serially collected plasma cell-free DNA were characterized by comprehensive genomic analyses. Immune markers were measured in tumor cores and margins by multiplex IHC.<h4>Results</h4>At a median follow-up of 47.4 months, the median overall survival (OS) and 2-year OS rate were 12.7 months and 32% in all evaluable patients (n = 88) and 17.5 months and 35% in patients who had no prior therapy for R/M HNSCC (n = 43). The Clinical cancer research : an official journal of the American Association for Cancer ResearchLong-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer.PMC12667737P30-CA076292James and Esther King Biomedical Research Grant (21K04)P30 CA076292R01 DE030508R01DE030493R01 DE030493Li JChaudhary RGetz GChung CHKirtane KAmelio ALMoorhead GPark RBiernacki MIGuevara-Patino JATan AHernandez-Prera JRocco JWBonomi MSlebos RJCMeshkovska YFreeman SSSaba NFSchell MJDanysh BPSong XThatikonda SHaradhvala NJfalseLong-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer.<h4>Purpose</h4>We report long-term survival and comprehensive molecular biomarker analyses of a phase II trial evaluating the combination of cetuximab and nivolumab in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).<h4>Patients and methods</h4>The long-term follow-up data were obtained from a phase II trial (NCT03370276). Archived tumors and serially collected plasma cell-free DNA were characterized by comprehensive genomic analyses. Immune markers were measured in tumor cores and margins by multiplex IHC.<h4>Results</h4>At a median follow-up of 47.4 months, the median overall survival (OS) and 2-year OS rate were 12.7 months and 32% in all evaluable patients (n = 88) and 17.5 months and 35% in patients who had no prior therapy for R/M HNSCC (n = 43). The 2026-01-01T00:00:00Z2026 Feb2026-07-15T06:57:35.091Z2026-06-30T03:34:32.895ZS-EPMC126677374111785710.1158/1078-0432.CCR-25-220110.1158/1078-0432.ccr-25-2201