Last updated on July 2018

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)

Brief description of study

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 overall survival (OS) as compared to treatment with standard therapy.

Detailed Study Description

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.

Clinical Study Identifier: NCT02564263

Contact Investigators or Research Sites near you

Start Over

Georgina Arnold

Petaling Jaya, Malaysia