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First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
NCT03189719 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The overall primary efficacy hypotheses are as follows: 1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score \[CPS\] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy. 2. In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Cisplatin
- DRUG 5-FU
Study Locations (20)
Other
- Hospital Aleman ( Site 0605) — Buenos Aires
- Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602) — Buenos Aires
- Sanatorio Allende - Cordoba ( Site 0604) — Córdoba
- Hospital Privado Centro Medico Cordoba ( Site 0601) — Córdoba
New York
- Roswell Park Cancer Institute ( Site 0004) — Buffalo
- Weill Cornell Medical College ( Site 0024) — New York
New South Wales
- Blacktown Hospital ( Site 2000) — Blacktown
- Liverpool Hospital. ( Site 2001) — Liverpool
California
- Kaiser Permanente Southern California ( Site 0003) — West Los Angeles
Illinois
- The University of Chicago Medical Center ( Site 0001) — Chicago
Kansas
- University of Kansas ( Site 0029) — Westwood
Maryland
- University of Maryland Medical Center ( Site 0013) — Baltimore
Massachusetts
- Dana Farber Cancer Center ( Site 0009) — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 749 participants |
| Start Date | 2017-07-25 |
| Est. Completion | 2023-07-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03189719
The ClinicalTrials.gov registry entry for NCT03189719 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 749 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Esophageal Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03189719 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, New York, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03189719 about?
NCT03189719 is a clinical study titled "First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)". The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic eso...
What is the current status of trial NCT03189719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 749 participants. The study started on 2017-07-25. Estimated completion is 2023-07-10.
What conditions does trial NCT03189719 study?
This clinical trial studies the following conditions: Esophageal Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03189719?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Cisplatin (DRUG), 5-FU (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03189719?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03189719 being conducted?
This trial has 20 study locations across California, Illinois, Kansas, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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