A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
研究概览
简要总结
The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)
详细描述
The study is a randomized, open-label, phase III clinical trial. The main objective is to compare the efficacy of JS004 plus Toripalimab with Investigator-Selected Chemotherapy in treating patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL). The study will assess the safety and tolerability of JS004 combined with Toripalimab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be enrolled:
- •Age at least 18 years old, both males and females are eligible
- •Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR/PR in recent treatment) or refractory (failure to achieve CR/PR in recent treatment) status.
- •Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb)
- •ECOG: 0-2
- •At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.
排除标准
- •Known allergy or contraindication to the investigational drug or its components
- •Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions.
- •Presence of central nervous system (CNS) metastasis.
- •Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)
- •Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years
研究组 & 干预措施
JS004 plus Toripalimab
JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years
干预措施: JS004 in combination with Toripalimab (Biological)
Investigator-Selected Chemotherapy
Bendamustine or gemcitabine
干预措施: Bendamustine or gemcitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
时间窗: Up to approximately 36 months
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by IRC or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(Up to approximately 45 months)
- Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator(Up to approximately 36 months)
- Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator(Up to approximately 36 months)
- Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator(Up to approximately 36 months)
- Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator(Up to approximately 36 months)
- Incidence and severity of all adverse events (AE) that occurred during the clinical trial(Up to approximately 36 months)
- PK(Up to approximately 36 months)
- Immunogenicity profiles(Up to approximately 36 months)