Trial Purpose

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03615326

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 trastuzumab and FP (cisplatin and 5- fluorouracil) or CAPOX (oxaliplatin plus capecitabine)*

50% will receive placebo along with trastuzumab and FP (cisplatin and 5- fluorouracil) or CAPOX (oxaliplatin plus capecitabine)*

*

* Your doctor will decide which chemotherapy treatment (FP or CAPOX) is best for you.

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.

Trial start Icon

Dates

  • Actual study start date October 5, 2018
  • Estimated primary completion date December 15, 2023
  • Estimated study completion date December 30, 2024

Eligibility

Conditions Icon

Conditions

Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma

Age Range Icon

Age Range

18 - No Age Maximum

Sex Icon

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.

Discuss Icon

Discuss With Your Doctor

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

CLINICALTRIALS.GOV IDENTIFIER:

NCT03615326

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.