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A Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer
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.
Details
| Lead sponsor | Shanghai Junshi Bioscience Co., Ltd. |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | UNKNOWN |
| Enrolment | 88 |
| Start date | Tue Apr 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Head and Neck Squamous Cell Cancer
Interventions
- Toripalimab Injection
- Cetuximab Solution for infusion
Countries
China