A PHASE III RANDOMIZED OPEN-LABEL STUDY OF SINGLE AGENT PEMBROLIZUMAB VS PHYSICIANS´CHOICE OF SINGLE AGENT DOCETAXEL, PACLITAXEL, OR IRINOTECAN IN SUBJECTS WITHADVANCED/METASTATIC ADENOCARCINOMA AND SQUAMOUS CELL CARCINOMA OF THE ESOPHAGUS THATHAVE PROGRESSED AFTER FIRST-LINE STANDARD THERAPY (KEYNOTE-181)

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 2 人开始时间: 2016年3月14日最近更新: 2023年9月4日

试验速览

暂无简介。

•-Provide written informed consent
•-≥ 18 years of age
•-histologically or cytologically-confirmed diagnosis of adenocarcinoma or
•squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the
•EGJ. HER-2/neu negative tumors are eligible. HER2/neu positive tumors must have documentation of disease
•progression on treatment containing trastuzumab
•-Metastatic disease or locally advanced, unresectable disease
•-Life expectancy of greater than 3 months
•-Measurable disease based on RECIST 1.1
•-Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
•-Have experienced documented objective radiographic or clinical disease progression during or after first-line locally or globally recommended therapy
•-Provide a tissue sample for intratumoral immune-related GEP analysis
•-Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
•-Must be willing to use an adequate method of contraception; male participants should also agree not to not to donate sperm starting with the first dose of study therapy through 120 days after the
•last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan.

•-Participating and receiving study therapy (or in the past) -4 weeks of 1st dose
•-Active autoimmune disease that has required systemic treatment -2 years
•-Immunodeficiency or receiving systemic steroid or immunosuppresive therapy -7 days of 1st dose
•-Active CNS metastases and/or carcinomatous meningitis
•-Prior anti-cancer monoclonal antibody, chemotherapy, targeted small molecule therapy, or radiation - 2 weeks prior to Day 1 or not recovered from AE
•-Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or if participated in pembrolizumab trial
•-Additional malignancy- 5 years prior to randomization
•-Live vaccine -30 days of 1st dose
•-history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results
•-Know history of HIV
•-Known active Hepatitis B or C
•-History or evidence of interstitial lung disease or active, noninfectious pneumonitis
•-Active infection requiring systemic therapy
•-Psychiatric or substance abuse disorders
•-Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of trial
•-known allergy, hypersensitivity, or contraindication to paclitaxel, docetaxel, or irinotecan
•-Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial

发起方

MERCK SHARP & DOHME PERU S.R.L.,