CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled
Drug / intervention
pembrolizumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03933449
NCT03933449Phase 3Completed

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)

Merck Sharp & Dohme LLC·interventional·Posted May 1, 2019·Updated Mar 29, 2023

In Brief

A Phase 3 clinical trial evaluating pembrolizumab, paclitaxel, and 2 other interventions for Esophageal Carcinoma and Esophagogastric Junction Carcinoma. Completed, enrolled 123 participants across 23 sites.

Detailed Summary

In the China extension study, Chinese 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 chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 1, 2019
Enrollment StartDec 29, 2016
Primary CompletionFeb 13, 2019
Study CompletionMar 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.2 years ago

Interventions

pembrolizumabbiological

IV infusion

paclitaxeldrug

IV infusion

docetaxeldrug

IV infusion

irinotecandrug

IV infusion