A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 622
- 主要终点
- Overall Survival in All Participants
研究概览
简要总结
In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.
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
- None
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
- •Centrally confirmed Stage IV/M1 mTNBC
- •Newly obtained tumor biopsy from metastatic site
- •Central determination of programmed cell death ligand 1 (PD-L1) tumor status
- •Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
- •Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
- •Adequate organ function
排除标准
- •Participation in another clinical trial within 4 weeks
- •Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
- •Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks
- •Active autoimmune disease that required systemic treatment in the past 2 years
- •Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days
- •Known additional malignancy that required treatment or progressed in last 5 years
- •Known active brain metastases and/or carcinomatous meningitis
- •Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies
研究组 & 干预措施
Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). Qualified participants who receive first course of pembrolizumab but continue to experience disease progression may, at investigator's discretion, initiate a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to ~1 year).
干预措施: pembrolizumab (Biological)
Chemotherapy
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
干预措施: capecitabine (Drug)
Chemotherapy
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
干预措施: eribulin (Drug)
Chemotherapy
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
干预措施: gemcitabine (Drug)
Chemotherapy
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
干预措施: vinorelbine (Drug)
结局指标
主要结局
Overall Survival in All Participants
时间窗: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Overall survival (OS) was defined as the time from randomization to death due to any cause.
Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10
时间窗: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Overall survival (OS) was defined as the time from randomization to death due to any cause.
Overall Survival in Participants With PD-L1 CPS ≥1
时间窗: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Overall survival (OS) was defined as the time from randomization to death due to any cause.
次要结局
- Progression-Free Survival Per RECIST 1.1 in All Participants(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response(Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019))
- Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Number of Participants Who Experienced One or More Adverse Events(Up to approximately 60 months)
- Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Disease Control Rate Per RECIST 1.1 in All Participants(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event(Up to approximately 60 months)
- Overall Response Rate Per RECIST 1.1 in All Participants(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))
- Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response(Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019))
- Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response(Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019))
- Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1(Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019))