Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
Public ClinicalTrials.gov record NCT03615326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
Study identification
- NCT ID
- NCT03615326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Merck Sharp & Dohme LLC
- Industry
- Enrollment
- 738 participants
Conditions and interventions
Interventions
- 5-FU Drug
- Capecitabine Drug
- Cisplatin Drug
- Oxaliplatin Drug
- Pembrolizumab Biological
- Placebo Biological
- S-1 Drug
- Trastuzumab Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2018
- Primary completion
- Mar 19, 2024
- Completion
- Nov 11, 2025
- Last update posted
- Dec 10, 2025
2018 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045) | Los Angeles | California | 90095 | — |
| Pacific Cancer Care ( Site 0063) | Monterey | California | 93940 | — |
| UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050) | Orange | California | 92868 | — |
| University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026) | Miami | Florida | 33136 | — |
| Southeastern Regional Medical Center, Inc. ( Site 0058) | Newnan | Georgia | 30265 | — |
| Midwestern Regional Medical Center, Inc. ( Site 0059) | Zion | Illinois | 60099 | — |
| Beth Israel Deaconess Medical Center ( Site 0070) | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute [Boston, MA] ( Site 0010) | Boston | Massachusetts | 02215 | — |
| Minnesota Oncology Hematology, PA ( Site 8001) | Minneapolis | Minnesota | 55404 | — |
| Washington University School of Medicine ( Site 0040) | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071) | Middletown | New Jersey | 07748 | — |
| Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065) | Harrison | New York | 10604 | — |
| Memorial Sloan-Kettering Cancer Center ( Site 0017) | New York | New York | 10065 | — |
| University of Rochester ( Site 0041) | Rochester | New York | 14642 | — |
| Levine Cancer Institute ( Site 0015) | Charlotte | North Carolina | 28204 | — |
| Duke Cancer Institute ( Site 0042) | Durham | North Carolina | 27710 | — |
| CTCA Southwestern ( Site 0060) | Tulsa | Oklahoma | 74133 | — |
| Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025) | Philadelphia | Pennsylvania | 19124 | — |
| Allegheny General Hospital ( Site 0053) | Pittsburgh | Pennsylvania | 15212 | — |
| Sanford Hematology Oncology-Sioux Falls SD ( Site 0004) | Sioux Falls | South Dakota | 57104 | — |
| University of Texas MD Anderson Cancer Center ( Site 0001) | Houston | Texas | 77030 | — |
| Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000) | Roanoke | Virginia | 24014 | — |
| Seattle Cancer Care Alliance ( Site 0038) | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 169 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03615326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2025 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03615326 live on ClinicalTrials.gov.