NCT04568304撤回3 期
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy as the 1st-line Therapy for Treatment-naive Subjects With PD-L1-positive Locally Advanced or Metastatic Urothelial Carcinoma
Shanghai Junshi Bioscience Co., Ltd.3 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2022年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 364
- 试验地点
- 3
- 主要终点
- Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have full knowledge on this study and are willing to sign informed consent form (ICF);
- •Age 18-75 years at time of signing ICF, male or female;
- •The investigator judged that the subject is eligible for platinum-based chemotherapy;
- •Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;
- •No prior systemic anti-tumor therapy;
- •Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and the corresponding pathology report and whose PD-L1 test must be positive before randomization;
- •With at least one measurable lesion as per RECIST 1.1 criteria;
- •ECOG performance status score of 0-1;
- •Adequate function of vital organs.
排除标准
- •Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;
- •Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;
- •Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;
- •Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;
- •Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10 mg/day) within 14 days before randomization;
- •Subjects with active central nervous system (CNS) metastasis;
- •Grade 2 or higher peripheral neuropathy or hearing loss.
研究组 & 干预措施
Toripalimab Injection + chemotherapy group
Experimental
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
Toripalimab Injection + chemotherapy group
Experimental
干预措施: Toripalimab Injection (Biological)
Placebo + chemotherapy group
Placebo Comparator
干预措施: Placebo (Drug)
Toripalimab Injection + chemotherapy group
Experimental
干预措施: Cisplatin for Injection / Carboplatin Injection (Drug)
Placebo + chemotherapy group
Placebo Comparator
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
Placebo + chemotherapy group
Placebo Comparator
干预措施: Cisplatin for Injection / Carboplatin Injection (Drug)
结局指标
主要结局
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
时间窗: Approximately 3 years
To evaluate the investigator-assessed progression-free survival following Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy
次要结局
- OS rate at 1 year(Approximately 3 years)
- INV-ORR, IRC-ORR(Approximately 3 years)
- OS rate at 2 years(Approximately 4 years)
- INV-DoR, IRC- DoR(Approximately 3 years)
- IRC-PFS(Approximately 3 years)
- OS(Approximately 5 years)
- INV-PFS rate and IRC-PFS rate at 6 months(Approximately 2.5 years)
- INV-PFS rate and IRC-PFS rate at 1 year(Approximately 3 years)
- INV-DCR, IRC-DCR(Approximately 3 years)
- Incidence of AEs/SAEs(Approximately 4 years)
研究者
研究点 (3)
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