A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
研究概览
简要总结
This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
- •No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
- •Eligible for taxane monotherapy；
- •Eastern Cooperative Oncology Group performance status of 0 or 1；
- •Measurable disease as defined by RECIST v1.1；
- •Adequate hematologic and end-organ function。
排除标准
- •Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
- •History of autoimmune disease；
- •History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
- •Prior allogeneic stem cell or solid organ transplantation;
- •Active hepatitis B or hepatitis C;
- •Positive of HIV antibody.
研究组 & 干预措施
Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
干预措施: Placebo (Drug)
JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
干预措施: JS001，an engineered anti-PD-1 antibody (Drug)
JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
干预措施: Nab-Paclitaxel (Drug)
Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
干预措施: Nab-Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
时间窗: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
次要结局
- Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC(From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months))
- OS rate at 24 months(the percent of participants that are alive at 24 months from Day 1.)
- PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator(From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months))
- Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator(From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months))
- Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC(From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months))
- Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC(From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months))
- Overall Survival (OS)(From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months))
- OS rate at 12 months(the percent of participants that are alive at 12months from Day 1.)
- Percentage and severity of Participants With Adverse Events (AEs)(From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months))
- ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator(From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months))
- Percentage of Participants With Anti-Drug Antibodies (ATAs)(Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days))
- DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator(From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months))
- DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator(From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months))