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 Progressed After First-Line Standard Therapy (KEYNOTE-181)
This is a Randomized, multi-center, open-label trial of pembrolizumab (MK-3475) versus investigator's choice of paclitaxel, docetaxel or irinotecan in subjects with advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric junction (EGJ). Siewert type I tumors are adenocarcinomas of the lower esophagus with the center located within 1cm to 5cm above the anatomic EGJ. Subjects will be required to have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, and to have been previously treated with one prior line of standard therapy per local/global guidelines. Subjects will be required to provide a tumor sample, to be evaluated at a central laboratory for analysis of immune-related gene expression profile (GEP) for response prediction for pembrolizumab efficacy. An evaluable tumor specimen for GEP status must be available and confirmed evaluable prior to enrollment.