NCT02564263

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)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 had progressed after first-line standard therapy were randomized to receive either pembrolizumab (MK-3475) OR the Investigator's choice of standard chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary study hypothesis was that treatment with pembrolizumab would prolong overall survival (OS) as compared to treatment with standard chemotherapy.

Conditions

• Esophageal Carcinoma
• Esophagogastric Junction Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	200 mg administered as IV infusion on Day 1 of every 21-day cycle
DRUG	paclitaxel	80-100 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle
DRUG	docetaxel	75 mg/m\^2 administered as IV infusion on Day 1 of every 21-day cycle
DRUG	irinotecan	180 mg/m\^2 administered as IV infusion on Day 1 of every 14-day cycle

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-10-15
• Completion: 2022-03-14
• First posted: 2015-09-30
• Last updated: 2023-03-13
• Results posted: 2019-11-20

Regulatory

• FDA-regulated drug study