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About this trial

The main aims of this trial are to compare progression-free survival and overall survival between the two groups.

Other aims of this trial include comparing the overall response rate and duration of response to treatment between the two groups, and documenting side effects to treatment and whether patients had to discontinue treatment due to side effects.

Patient Profile

This study is open to men and women over 18 years of age with confirmed advanced or metastatic cancer of the oesophagus, or the junction between the oesophagus and the stomach. In addition to the location of their primary cancer, the type of cells in the patient’s cancer are also of relevance to this study; patients must have a tumour which is Human Epidermal Growth Factor Receptor (HER 2) positive to participate. Patients cannot have had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer to be eligible to participate in this trial.

Where’s this trial being run?

Beaumont Hospital, St James’s Hospital, and Tallaght University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: MK3475-811 (KEYNOTE 811)
Number: 18-12
Full Title:

A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab or Placebo as First-line Treatment in Participants With HER2 Positive Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

Principal Investigator: Prof Maeve Lowery (SJH)
Type: Industry Sponsored
Sponsor:

MSD

Recruitment Started: Global: Unknown
Ireland: December 2018
Global Recruitment Target: 692
Ireland Recruitment Target: 12