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

NCT04856631 PHASE1, PHASE2 UNKNOWN

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 sponsorShanghai Junshi Bioscience Co., Ltd.
PhasePHASE1, PHASE2
StatusUNKNOWN
Enrolment88
Start dateTue Apr 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionThu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

China