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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18 - 75Age 18 - 75

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractOesophagus, Gastro-oesophageal junction, Stomach

Trial Overview Read MoreRead more

This phase III trial is comparing pembrolizumab (an immunotherapy agent) with standard therapy for patients with advanced oesophageal and gastro-oesophageal junction cancers that have gotten worse after first line treatment.
 

This trial is treating patients with Oesophageal and Gastro-Oesophageal Junction Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have previously been treated (or are currently being treated) on a clinical trial.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Merck

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 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 progression-free survival (PFS) and/or overall survival (OS) as compared to treatment with standard therapy.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Nikki Cross
n.cross@alfred.org.au
03 9076 3534

PCCTU (Parkville cancer clinical trials unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140