Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)

Official Title

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)


In this study, participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of standard therapy with paclitaxel, docetaxel, or irinotecan. The primary study hypothesis is that treatment with pembrolizumab will prolong progression-free survival (PFS) and/or overall survival (OS) as compared to treatment with standard therapy.

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR)
This study will enroll 2 cohorts: the global cohort and the China cohort. The global cohort will enroll 600 participants and enrollment for the China cohort will contribute to this total. Enrollment will be extended for the China cohort until 120 participants are enrolled in this cohort. The China enrollment extension may extend the study approximately 2 years.

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Canadian Cancer Society

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