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
Overview
- Phase
- Phase 1
- Intervention
- Toripalimab Injection
- Conditions
- Head and Neck Squamous Cell Cancer
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Objective response rate(ORR)evaluated by RECIST 1.1-Phase2
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental group
Toripalimab Injection (JS001) + Cetuximab
Intervention: Toripalimab Injection
Experimental group
Toripalimab Injection (JS001) + Cetuximab
Intervention: Cetuximab Solution for infusion
Outcomes
Primary Outcomes
Objective response rate(ORR)evaluated by RECIST 1.1-Phase2
Time Frame: Up to 2 years
Evaluate efficacy of the combination therapy in treatment of relapsed or metastatic HNSCC in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as objective response rate (ORR) evaluated
Incidence and severity of adverse event (AE) and serious adverse event (SAE)-Phase1
Time Frame: Up to 2 years
Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0; and abnormalities in vital signs, ECG and laboratory tests, etc.
Secondary Outcomes
- Overall survival（OS）(Up to 2 years)
- Objective response rate(ORR)evaluated by the investigator-Phase2(Up to 2 years)
- Disease control rate（DCR）and Duration of response（DOR）and progression-free survival (PFS).-Phase2(Up to 2 years)
- Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE V5.0(Up to 2 years)