NCT04856631

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

A Phase Ib/II, Single-arm, Multi-center Clinical Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study consists of the screening period, treatment period, and follow-up period. The screening period is not more than 28 d; after completion of the examinations and assessment in the screening period, eligible subjects enter the investigational therapy period. The subjects will receive the investigational medical product in accordance with the Protocol until radiologically documented progressive disease as judged by the investigator in accordance with RECIST 1.1 criteria, intolerable toxicity, voluntary termination of the treatment or voluntary withdrawal of the informed consent by the subject, or termination of the treatment as judged by the investigator, or until 2 years of JS001 treatment duration (whichever occurs first).

Conditions

• Head and Neck Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab Injection	240mg once per 3 weeks
DRUG	Cetuximab Solution for infusion	First infusion 400mg/m2，Subsequent infusions 250mg/m2。once per week

Timeline

• Start date: 2021-04-06
• Primary completion: 2022-11-30
• Completion: 2023-11-30
• First posted: 2021-04-23
• Last updated: 2022-12-19

Locations

1 site across 1 country: China