A Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer

Summary

This study is a Phase Ib/II, open-label, multicenter clinical trial. Here, the study phase Ib is mainly to evaluate safety of combination regimen of Toripalimab and Cetuximab in treatment of relapsed or metastatic HNSCC failing first-line platinum-based therapy and determine the recommended Phase II dose (RP2D); the study phase II is divided into two cohorts. Cohort A used to evaluate the efficacy and safety of the combination of regimen for relapsed or metastatic HNSCC failing first-line platinum-based regimen containing chemotherapy;cohort B used to evaluate the efficacy and safety of the combination regimen for PD-L1-positive HNSCC that have not received prior systemic therapy for relapsed or metastatic disease.

Timeline

Start

2021-04-06

Primary completion

2022-11-30

Completion

2023-11-30

Publications

• Guo Y, Li Z, Xue L, Lin J, Qu S, Sun C, Fang M, Zhu Y, Zong J, Chen W, Cao G, Wu J, Ge M, Li Z, Wang S, Wang X, Jiang H, Hu D, Shen L, Wei Y, Jin C, Zhang H, Huang X, Sun Y, Shi J, Wang M, Luo X, Kuang S, Wei S, Deng R, Shen Y. Efficacy and safety of toripalimab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): a phase 1b/2 study. Signal Transduct Target Ther. 2026 Jun 9;11(1):223. doi: 10.1038/s41392-026-02707-3.

Drugs

Indications