Phase 3 Study of Pembrolizumab in Esophageal and Esophagogastric Junction Cancers

Share this content:
For this study, patients will receive pembrolizumab monotherapy or investigator’s choice of paclitaxel, docetaxel, or irinotecan.
For this study, patients will receive pembrolizumab monotherapy or investigator’s choice of paclitaxel, docetaxel, or irinotecan.

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.

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.

Reference

  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.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters