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NCT06356311 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
A Phase 3 study of GastroEsophageal Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06356311: Active Phase 3 study of GastroEsophageal Cancer, sponsored by Merck Sharp & Dohme.
NCT06356311 is a Phase 3 study of GastroEsophageal Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 450 participants, roughly in line with the 477-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target. The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06356311, a Phase 3 study of GastroEsophageal Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).
Primary Outcome
OS is defined as the time from randomization to death due to any cause.
Conditions Studied
Interventions
- BIOLOGICAL Sacituzumab tirumotecan
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Irinotecan
- DRUG Trifluridine-Tipiracil
Study Locations (20)
Kentucky
- University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124) - Lexington
- The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113) - Louisville
- Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105) - Louisville
Bruxelles-Capitale, Region de
- Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003) - Anderlecht
- Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001) - Brussels
Arizona
- Banner MD Anderson Cancer Center ( Site 0119) - Gilbert
California
- UCLA Hematology/Oncology - Santa Monica ( Site 0140) - Los Angeles
Florida
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129) - Orlando
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108) - Marietta
Illinois
- University of Chicago Medical Center ( Site 0120) - Chicago
Michigan
- Henry Ford Hospital ( Site 0107) - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-05-03 |
| Est. Completion | 2027-05-06 |
| Phase | Phase 3 |
What the registry record for NCT06356311 still lists
NCT06356311 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 477-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target.
The record links to 1 condition, with GastroEsophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Sacituzumab tirumotecan is the first listed.
NCT06356311 names 20 study sites across 17 states, led by Kentucky, Bruxelles-Capitale, Region de, Arizona.
Frequently Asked Questions
What is clinical trial NCT06356311 about?
NCT06356311 is a clinical study titled "A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)". This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Over...
What is the current status of trial NCT06356311?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-05-03. Estimated completion is 2027-05-06.
What conditions does trial NCT06356311 study?
This clinical trial studies the following conditions: GastroEsophageal Cancer.
What interventions are being tested in trial NCT06356311?
The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Docetaxel (DRUG), Paclitaxel (DRUG), Irinotecan (DRUG), Trifluridine-Tipiracil (DRUG).
Who is sponsoring clinical trial NCT06356311?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06356311 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06356311's enrollment target sits among peer trials
450 2nd of 23 the highest of 23 other GastroEsophageal Cancer trials
participants (enrollment target), bucketed by value
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