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)1

Description: For this randomized, phase 3 study (ClinicalTrials.gov Identifier: NCT02564263), patients who failed at least 1 line of standard therapy for advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, or Siewert type I adenocarcinoma of the esophagogastric junction, will receive single agent-agent pembrolizumab or investigator’s choice of standard therapy.

The study has 2 arms: in the first arm, patients will receive pembrolizumab monotherapy; in the second arm patients will receive the investigator’s choice of paclitaxel, docetaxel, or irinotecan.

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Primary outcomes are progression-free survival and overall survival; the secondary outcome is objective response rate.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02564263.

Status: This study is open and recruiting patients as of April 7, 2017.

This study is sponsored by Merck Sharp & Dohme Corp.


  1. Clinicaltrials.gov. 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). NCT02564263. https://clinicaltrials.gov/ct2/show/NCT02564263. Accessed April 7, 2017.