A Randomized, Double-Blind, Multicenter, Phase III Study of Toripalimab(JS001) in Combination With Nab-Paclitaxel Versus Placebo Plus Nab-Paclitaxel for Patients With Metastatic or Recurrent Triple-Negative Breast Cancer With or Without Systemic Treatment (TORCHLIGHT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 531
- 试验地点
- 55
- 主要终点
- Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intend to Treat patients.
研究概览
简要总结
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic or recurrent triple negative breast cancer (TNBC);
- •Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
- •Eligible for taxane monotherapy;
- •No more than one line of chemotherapy in metastatic setting;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Life expectancy of 12 weeks or more;
- •At least one measurable lesion per RECIST v1.1;
- •Demonstrate adequate hematologic and organ functions as defined in the protocol
排除标准
- •Prior treatment with taxane as first line treatment;
- •Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway)
- •MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (>10 mg/d prednisone or equivalent) > 4 weeks before randomization can participate in the study;
- •Meningeal carcinomatosis;
- •Pregnancy or lactation;
- •Active hepatitis B or hepatitis C.
研究组 & 干预措施
JS001 Plus Nab-Paclitaxel
Patients will receive both JS001 and Nab-Paclitaxel.
干预措施: Nab-Paclitaxel (Drug)
Placebo Plus Nab-Paclitaxel
Patients will receive both placebo and Nab-Paclitaxel.
干预措施: Placebo (Drug)
JS001 Plus Nab-Paclitaxel
Patients will receive both JS001 and Nab-Paclitaxel.
干预措施: JS001 (Drug)
Placebo Plus Nab-Paclitaxel
Patients will receive both placebo and Nab-Paclitaxel.
干预措施: Nab-Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intend to Treat patients.
时间窗: Up to approximately 61 months from first patient in.
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the BIRC 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.
PFS assessed by BICR using RECIST v1.1 in PD-L1 positive patients
时间窗: Up to approximately 61 months from first patient in.
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 due to 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
- Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intend to Treat patients.(Up to approximately 61 months from first patient in.)
- Disease control rate (DCR) assessed by BICR or investigators using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- Objective response rate (ORR) assessed by BICR or investigators using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- Duration of response (DoR) assessed by BICR or investigators using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- Overall Survival (OS). Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- OS rate at 12 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- OS rate at 24 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(Up to approximately 61 months from first patient in.)
- Differences in safety and tolerability as assessed by the occurrence of adverse events. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(From Day 1 to death from any cause, assessed up to end of study (up to approximately 46 months）)
- Differences in the scores of disease/treatment-related symptoms evaluted by ECOG Performance Status. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.(From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months))