drugset / Trial / NCT03370276
Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
Phase 1/2
Completed
95 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collabEli Lilly and Company · collabJames and Esther King Biomedical Research Program · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.
Timeline
- Start
- 2017-12-20
- Primary completion
- 2021-09-04
- Completion
- 2023-12-23
Publications
- Park R, Rind F, Kristoff T, Li J, Schell M, Slebos RJC, Thatikonda S, Chaudhary R, Biernacki MI, Meshkovska Y, Kaldas D, Kim HS, Farinhas J, Hernandez-Prera J, Kirtane K, Hall MS, Amelio AL, Rocco JW, Bhateja P, Steuer C, Bonomi M, Saba NF, Chung CH. Evaluation of Neutrophil to Lymphocyte Ratio in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Treated With a Combination of Cetuximab and Nivolumab in a Phase II Clinical Trial. Am J Clin Oncol. 2026 Apr 1;49(4):176-187. doi: 10.1097/COC.0000000000001255. Epub 2025 Sep 4.
- Wang X, Muzaffar J, Kirtane K, Song F, Johnson M, Schell MJ, Li J, Yoder SJ, Conejo-Garcia JR, Guevara-Patino JA, Bonomi M, Bhateja P, Rocco JW, Steuer CE, Saba NF, Chung CH. T cell repertoire in peripheral blood as a potential biomarker for predicting response to concurrent cetuximab and nivolumab in head and neck squamous cell carcinoma. J Immunother Cancer. 2022 Jun;10(6):e004512. doi: 10.1136/jitc-2022-004512.