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Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

  • Chung, Christine H1
  • Li, Jiannong2
  • Steuer, Conor E3
  • Bhateja, Priyanka4
  • Johnson, Matthew1
  • Masannat, Jude1
  • Poole, Maria I1
  • Song, Feifei1
  • Hernandez-Prera, Juan C5
  • Molina, Helen5
  • Wenig, Bruce M5
  • Kumar, Sunil6
  • Kuperwasser, Charlotte6
  • Stephens, Philip J6
  • Farinhas, Joaquim M7
  • Shin, Dong M3
  • Kish, Julie A8
  • Muzaffar, Jameel1
  • Kirtane, Kedar1
  • Rocco, James W9
  • And 3 more
  • 1 Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.
  • 2 Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
  • 3 Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia. , (Georgia)
  • 4 Department of Internal Medicine and The James Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
  • 5 Department of Pathology, Moffitt Cancer Center, Tampa, Florida.
  • 6 Naveris Inc., Natick, Massachusetts.
  • 7 Department of Radiology, Moffitt Cancer Center, Tampa, Florida.
  • 8 Department of Personalized Medicine, Moffitt Cancer Center, Tampa, Florida.
  • 9 Department of Otolaryngology and The James Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, Ohio.
Published Article
Clinical Cancer Research
American Association for Cancer Research
Publication Date
Jun 01, 2022
DOI: 10.1158/1078-0432.CCR-21-3849
PMID: 35344035


A phase II multi-institutional clinical trial was conducted to determine overall survival (OS) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab and nivolumab. Patients with R/M HNSCC were treated with cetuximab 500 mg/m2 i.v. on day 14 as a lead-in followed by cetuximab 500 mg/m2 i.v. and nivolumab 240 mg i.v. on day 1 and day 15 of each 28-day cycle. Expression of p16 and programmed cell death-ligand 1 (PD-L1) in archived tumors were determined. Tumor-tissue-modified human papillomavirus (TTMV) DNA was quantified in plasma. Ninety-five patients were enrolled, and 88 patients were evaluable for OS with a median follow-up of 15.9 months. Median OS in the 45 patients who had prior therapy for R/M HNSCC (cohort A) was 11.4 months, with a 1 year OS 50% [90% confidence interval (CI), 0.43-0.57]. Median OS in the 43 patients who had no prior therapy (cohort B) was 20.2 months, with a 1-year OS 66% (90% CI, 0.59-0.71). In the combined cohorts, the p16-negative immunostaining was associated with higher response rate (RR; P = 0.02) but did not impact survival while higher PD-L1 combined positive score was associated with higher RR (P = 0.03) and longer OS (log-rank P = 0.04). In the p16-positive patients, lower median (1,230 copies/mL) TTMV DNA counts were associated with higher RR (P = 0.01) and longer OS compared with higher median (log-rank P = 0.05). The combination of cetuximab and nivolumab is effective in patients with both previously treated and untreated R/M HNSCC and warrants further evaluation. ©2022 American Association for Cancer Research.

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