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Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
NCT04210115 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants
Conditions Studied
Interventions
- DRUG placebo
- BIOLOGICAL pembrolizumab
- DRUG 5-FU
- DRUG cisplatin
- RADIATION radiotherapy
Study Locations (20)
Kansas
- University of Kansas Cancer Center ( Site 0023) — Westwood
- Cancer Center of Kansas ( Site 0058) — Wichita
California
- MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691) — Long Beach
Georgia
- Columbus Regional Research Institute ( Site 0047) — Columbus
Louisiana
- University Medical Center ( Site 0035) — New Orleans
Maryland
- Greater Baltimore Medical Center ( Site 0031) — Baltimore
Massachusetts
- Dana Farber Cancer Center ( Site 0034) — Boston
Michigan
- Henry Ford Hospital ( Site 0685) — Detroit
Missouri
- University of Missouri ( Site 0688) — Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 703 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04210115
The ClinicalTrials.gov registry entry for NCT04210115 describes a study currently listed as active not recruiting. 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 703 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 3 conditions, with Esophageal Squamous Cell Carcinoma (ESCC) appearing as the primary indexed condition, and to 5 interventions — of which placebo 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: NCT04210115 reports 20 study locations spanning 19 distinct geographic areas — top geographies include Kansas, California, Georgia. 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 NCT04210115 about?
NCT04210115 is a clinical study titled "Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)". The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Progra...
What is the current status of trial NCT04210115?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 703 participants. The study started on 2020-02-28. Estimated completion is 2027-02-01.
What conditions does trial NCT04210115 study?
This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma (ESCC), Gastroesophageal Junction Carcinoma (GEJC), Esophageal Adenocarcinoma (EAC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04210115?
The interventions under investigation include: placebo (DRUG), pembrolizumab (BIOLOGICAL), 5-FU (DRUG), cisplatin (DRUG), radiotherapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04210115?
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 NCT04210115 being conducted?
This trial has 20 study locations across California, Georgia, Kansas, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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