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 study hypotheses are that:

Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03221426

When speaking to your doctor, please have the trial identifier number available.

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 u2020

50% will receive placebo along with XP (cisplatin and capecitabine) or FP (cisplatin and 5-FU)* followed by surgical resection u2020

*

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 Phase Icon

Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.

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Dates

  • Actual study start date October 9, 2017
  • Estimated primary completion date February 29, 2024
  • Estimated study completion date June 28, 2024

Eligibility

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Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

What Can You Do Next?

If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.

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Discuss With Your Doctor

Print this page or email it to your doctor to discuss at your next visit.

CLINICALTRIALS.GOV IDENTIFIER:

NCT03221426

When speaking to your doctor, please have the trial identifier number available.

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.