NCT02559687已完成2 期
A Phase II Study of Pembrolizumab Monotherapy in Third Line Previously Treated Subjects With Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus or Advanced/Metastatic Siewert Type I Adenocarcinoma of the Esophagogastric Junction (KEYNOTE-180)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 主要终点
- Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
In this study participants with advanced/metastatic adenocarcinoma of the esophagus (EAC), squamous cell carcinoma of the esophagus (ESCC), or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric junction (EGJ), who had been previously treated with two standard therapies, will be treated with pembrolizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy greater than 3 months
- •Histologically-proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ
- •Documented objective radiographic or clinical disease progression on two previous lines of standard therapy
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- •Can provide either a newly obtained or archival tumor tissue sample for intratumoral immune-related testing and for anti-programmed cell death (PD-1)
- •Female participants of childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication
- •Male participants must agree to use adequate contraception starting with the first dose through 120 days after the last dose of study medication
- •Adequate organ function
排除标准
- •Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
- •Has active autoimmune disease that has required systemic treatment within the 2 years prior to the first dose of study medication
- •Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- •Known central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study medication or not recovered from adverse events due to a previously administered agent
- •Prior therapy with an anti-PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in a Merck pembrolizumab (MK-3475) study
- •Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in-situ cervical cancer, and in-situ or intra-mucosal pharyngeal cancer
- •Received a live vaccine within 30 days of the first dose of study medication
- •Known history of Human Immunodeficiency Virus (HIV) infection
- •Known active Hepatitis B or C
- •History of non-infectious pneumonitis that required steroids or current pneumonitis
- •Active infection requiring systemic therapy
- •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
- •Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication
结局指标
主要结局
Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 28 months
ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was reported per protocol for the first course of treatment.
次要结局
- Number of Participants Who Experienced an Adverse Event (AE)(Up to approximately 59 months)
- Number of Participants That Discontinued Study Treatment Due to an AE(Up to approximately 24 months)
- Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR(Up to approximately 67 months)
- Overall Survival (OS)(Up to approximately 67 months)
- Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR(Up to approximately 67 months)
研究者
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