A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 33
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.
详细描述
The master screening protocol is MK-3475-U06 (KEYMAKER-U06)
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 a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
- •Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC
- •Has measurable disease
- •If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy
- •Has adequate organ function
排除标准
- •Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype
- •Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- •Has clinically significant corneal disease
- •Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event
- •If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Has uncontrolled or significant cardiovascular disease
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has known active central nervous system metastases and/or carcinomatous meningitis
- •Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- •Has active infection requiring systemic therapy other than those permitted.
- •Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen
研究组 & 干预措施
I-DXd
Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met.
干预措施: I-DXd (Biological)
I-DXd
Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met.
干预措施: Rescue Medication (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 15 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
次要结局
- Duration of Response (DOR)(Up to approximately 18 months)
- Progression-Free Survival (PFS)(Up to approximately 18 months)
- Overall Survival (OS)(Up to approximately 27 months)
- Number of Participants Who Experience an Adverse Events (AEs)(Up to approximately 18 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 18 months)