Study protocol: phase II study to evaluate the effect of cetuximab monotherapy after immunotherapy with PD-1 inhibitors in patients with head and neck squamous cell cancer.

"Declarations Ethics approval and consent to participate: This study was approved by the Wake Forest Comprehensive Cancer Center Institutional Review Board (IRB00065239). Written and verbal consent has been obtained from all current participants and will be obtained from all future participants.Consent for publication: Not applicable. No identifying information has been included in this publication.Author contributions:Kimberly M. Burcher: Conceptualization; Visualization; Writing – original draft; Writing – review & editing.Chance H. Bloomer: Methodology; Visualization; Writing – original draft; Writing – review & editing.Elena Gavrila: Visualization; Writing – original draft; Writing – review & editing.John M. Kalada: Visualization; Writing – review & editing.Mark J. Chang: Writing – original draft; Writing – review & editing.Rediet R. Gebeyehu: Methodology; Writing – review & editing.Alexander H. Song: Visualization; Writing – review & editing.Lara M. Khoury: Visualization; Writing – review & editing.Thomas W. Lycan: Conceptualization; Methodology; Supervision.Rebecca Kinney: Visualization; Writing – review & editing.Ralph D’Agostino Jr.: Conceptualization; Methodology.Paul M. Bunch: Conceptualization; Methodology; Visualization; Writing – original draft.Kirtikar Shukla: Methodology; Writing – review & editing.Pierre Triozzi: Conceptualization; Methodology; Supervision.Cristina M. Furdui: Conceptualization; Methodology; Resources.Wei Zhang: Conceptualization; Methodology; Supervision.Mercedes Porosnicu: Conceptualization; Methodology; Supervision; Visualization; Writing – original draft; Writing – review & editing.Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The clinical study is supported by the Wake Forest Baptist Compressive Cancer Center Grant award number P30CA012197. MP’s effort was partly supported by NIH/NCI U01 CA215848. PB’s effort was partly supported by an AUR GE Radiology Research Academic Fellowship Award. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.Competing interests: MP received clinical research support from Boehringer Ingelheim, Astra Zeneca, Eli Lilly, Astellas, and Sanofi-Aventis. MP is a consultant for Boehringer Ingelheim.Availability of data and materials: Not applicable. Competing interests: MP received clinical research support from Boehringer Ingelheim, Astra Zeneca, Eli Lilly, Astellas, and Sanofi-Aventis. MP is a consultant for Boehringer Ingelheim."

"Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The clinical study is supported by the Wake Forest Baptist Compressive Cancer Center Grant award number P30CA012197. MP’s effort was partly supported by NIH/NCI U01 CA215848. PB’s effort was partly supported by an AUR GE Radiology Research Academic Fellowship Award. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH."

"Clinical trial registration: This study is registered on ClinicalTrials.gov: NCT04375384."