EUCTR2015-002782-32-NL进行中（未招募）1 期
A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs. Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects with Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus that have Progressed after First-Line Standard Therapy (KEYNOTE-181) - Study of Pembrolizumab vs Docetaxel, Paclitaxel or Irinotecan in Subjects with Esophagus Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must:
- •- Be = 18 years of age on the day of signing the informed consent.
- •- Have histologically or cytologically confirmed diagnosis of
- •adenocarcinoma or squamous cell carcinoma of the esophagus or
- •Siewert type I adenocarcinoma of the EGJ.
- •- Have metastatic disease or locally advanced, unresectable disease.
- •Subjects with direct invasion into adjacent organs such as the aorta or
- •trachea (T4b disease) should be closely evaluated for bleeding risk prior
- •to enrollment and a sponsor consultation before enrollment is required.
- •- Have a life expectancy greater than 3 months.
- •- Have measurable disease based on RECIST 1.1 as determined by local
- •site investigator/radiology assessment.
- •- Have an ECOG performance status of 0 or 1.
- •- Have experienced documented radiographic or clinical disease
- •progression on one previous line of standard therapy. This study will
- •only include second-line subjects. Second-line subjects are defined as
- •those who have progressed during or after receiving at least one dose of
- •standard therapy given in a first line setting.
- •- Provide either a newly obtained or archival tissue sample for
- •intratumoral immunerelated GEP analysis and PD-L1 by
- •immunohistochemistry analysis. Newly-obtained tissue is preferred.
- •Formalin-fixed, paraffin-embedded (FFPE) block specimens are preferred
- •- Demonstrate adequate organ function.
- •- Negative pregnancy test for females of child bearing potential prior to
- •starting study and male and female subjects of childbearing potential
- •must be willing to use an adequate method of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •The subject will be excluded from participating in the trial if the subject:
- •- Is 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 treatment.
- •- Has an active autoimmune disease that has required systemic
- •treatment in past 2 years.
- •- Has a diagnosis of immunodeficiency or is receiving systemic steroid
- •therapy or any other form of immunosuppressive therapy within 7 days
- •prior to the first dose of trial treatment.
- •- Has known central nervous system (CNS) metastases and/or
- •carcinomatous meningitis (includes past history or current metastasis).
- •- Has received prior anti-cancer monoclonal antibody (mAb),
- •chemotherapy, targeted small molecule therapy, or radiation therapy
- •within 2 weeks prior to study Day 1. Subjects must have recovered from adverse events due to a previously administered agent to baseline toxicity grade or to grade 1 or less prior to enrollment.
- •- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
- •agent, or if the subject has previously participated in Merck
- •pembrolizumab (MK-3475) clinical trials.
- •- Previously had a severe hypersensitivity reaction to treatment with
- •another monoclonal antibody (mAb).
- •- Has experienced documented objective radiographic or clinical disease
- •progression during or after receiving more than 1 line of therapy.
- •- Has a known additional malignancy that progressed or required active
- •treatment within the last 5 years. Exceptions include curatively treated
- •basal cell and squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers and in situ or
- •intramucosal pharyngeal cancer. Has received a live vaccine within 30
- •days of planned start of pembrolizumab.
- •- Has a history or current evidence of any condition, therapy, or
- •laboratory abnormality that might confound the results of the trial,
- •interfere with the subject's participation for the full duration of the trial,
- •or is not in the best interest of the subject to participate, in the opinion
- •of the treating investigator.
- •- Has a known history of Human Immunodeficiency Virus (HIV)
- •infection. No HIV testing is required unless mandated by local health
- •- Has known history of or is positive for Hepatitis B (hepatitis B surface antigen reactive) or known Hepatitis C (hepatitis C virus RNA or hepatitis C antibody is detected). No hepatitis testing is required unless mandated by local health authority.
- •- Has a history of (non-infectious) pneumonitis that required steroids or
- •current pneumonitis.
- •- Has an active infection requiring systemic therapy.
- •- Has known psychiatric or substance abuse disorders that would
- •interfere with cooperation with the requirements of the trial.
- •- Is pregnant or breastfeeding, or expecting to conceive or father
- •children within the projected duration of the trial, starting with the
- •screening visit through 120 days after the last dose of trial treatment.
- •- Has a Known allergy, hypersensitivity, or contraindication to
- •preselected chemotherapy agent (i.e. paclitaxel, docetaxel, or
- •irinotecan) or any components used in their preparation.
- •- Experienced weight loss > 10% over approximately 2 months prior to
- •first dose of study therapy.
- •- Has clinically apparent ascites or pleural effusion by physical exam.
- •(Note that small amount of ascites which is only detectable
研究者
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