Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04210115 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
A Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC) and Gastroesophageal Junction Carcinoma (GEJC), sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 703
- Enrollment target
- 20
- Study locations
NCT04210115 is a Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC) and Gastroesophageal Junction Carcinoma (GEJC) that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 703 participants, above the 478-participant average among 5 other Esophageal Squamous Cell Carcinoma (ESCC) trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 19 states.
The verdict
NCT04210115, a Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC) and Gastroesophageal Junction Carcinoma (GEJC), is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 703 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 703 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 478-participant average among 5 other Esophageal Squamous Cell Carcinoma (ESCC) trials with a reported enrollment target (47% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT04210115 reports 20 study locations spanning 19 distinct geographic areas - top geographies include Kansas, California, Georgia.
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).
What interventions are being tested in trial NCT04210115?
The interventions under investigation include: placebo (DRUG), pembrolizumab (BIOLOGICAL), 5-FU (DRUG), cisplatin (DRUG), radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT04210115?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Esophageal Squamous Cell Carcinoma (ESCC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
COMPLETED · Phase 3
-
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
COMPLETED · Phase 3
-
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer
RECRUITING
-
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
RECRUITING · Phase 1
Explore more on PlainTrial
Esophageal Squamous Cell Carcinoma (ESCC)
All registered trials for this condition
Gastroesophageal Junction Carcinoma (GEJC)
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.