At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Brief
A Phase 3 clinical trial evaluating pembrolizumab, paclitaxel, and 2 other interventions for Esophageal Carcinoma and Esophagogastric Junction Carcinoma. Completed, enrolled 628 participants.
Detailed 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.
Study Details
Timeline
Interventions
200 mg administered as IV infusion on Day 1 of every 21-day cycle
80-100 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle
75 mg/m\^2 administered as IV infusion on Day 1 of every 21-day cycle
180 mg/m\^2 administered as IV infusion on Day 1 of every 14-day cycle