Keynote 585

For patients prior to/after surgery with advanced gastric or GEJ adenocarcinoma

Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and pathological complete response (pathCR) rate.

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational immunotherapy to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 50% will receive pembrolizumab along with XP (cisplatin and capecitabine) or FP (cisplatin and 5-FU) * followed by surgical resection †
  • 50% will receive placebo along with XP (cisplatin and capecitabine) or FP (cisplatin and 5-FU) * followed by surgical resection †

You will be assigned by chance (a process called randomization) to receive one of the above treatments. 

 * Your doctor will decide which chemotherapy treatment is best for you. A small group of patients will be given FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel). 
† After surgery, you will receive XP or FP plus pembrolizumab or placebo followed by pembrolizumab or placebo alone.

Trial Purpose
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US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

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National Trial Reference Number

NCT03221426 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Gastric Cancer
  • Gastroesophageal Junction Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and pathological complete response (pathCR) rate.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

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    Location
    Status
  • Duarte, California, United States, 91010
    Recruiting
  • Fairfax, Virginia, United States, 22031
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19111
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19140
    Recruiting
  • Buffalo, New York, United States, 14263
    Recruiting
  • Salt Lake City, Utah, United States, 84112
    Recruiting
  • Chicago, Illinois, United States, 60637
    Recruiting
  • New Haven, Connecticut, United States, 06520
    Recruiting
  • Washington, District of Columbia, United States, 20007
    Recruiting
  • Rochester, New York, United States, 14642
    Recruiting
  • New York, New York, United States, 10016
    Recruiting
  • Chicago, Illinois, United States, 60611
    Recruiting
  • New York, New York, United States, 10065
    Recruiting
  • New York, New York, United States, 10065
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-585

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
keynote 585 trial logo

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.