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NCT04776148 · ClinicalTrials.gov registry record · Phase 3
Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)
A Phase 3 study of Colorectal Neoplasms, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 563
- Enrollment target
- 20
- Study locations
NCT04776148 is a Phase 3 study of Colorectal Neoplasms that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 563 participants, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target. The trial reports 20 study locations across 16 states.
The verdict
NCT04776148, a Phase 3 study of Colorectal Neoplasms, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 563 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG lenvatinib
- DRUG regorafenib
- DRUG TAS-102 (trifluridine and tipiracil)
Study Locations (20)
Maryland
- MFSMC-HJWCI-Oncology Research ( Site 0012) - Baltimore
- MedStar Good Samaritan Hospital-Oncology Research ( Site 0038) - Baltimore
Virginia
- Inova Schar Cancer Institute ( Site 0022) - Fairfax
- Blue Ridge Cancer Care ( Site 0036) - Roanoke
Other
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0303) - Buenos Aires
- IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0300) - Buenos Aires
Queensland
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
- Gallipoli Medical Research Foundation-GMRF CTU ( Site 1500) - Greenslopes
California
- Pacific Cancer Care ( Site 0031) - Monterey
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021) - Marietta
Illinois
- University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P - Chicago
Michigan
- Henry Ford Hospital ( Site 0024) - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 563 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04776148
The ClinicalTrials.gov registry entry for NCT04776148 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 563 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which pembrolizumab is the first listed.
NCT04776148 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Maryland, Virginia, Other.
Frequently Asked Questions
What is clinical trial NCT04776148 about?
NCT04776148 is a clinical study titled "Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)". The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and...
What is the current status of trial NCT04776148?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 563 participants. The study started on 2021-03-29. Estimated completion is 2024-09-27.
What conditions does trial NCT04776148 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT04776148?
The interventions under investigation include: pembrolizumab (DRUG), lenvatinib (DRUG), regorafenib (DRUG), TAS-102 (trifluridine and tipiracil) (DRUG).
Who is sponsoring clinical trial NCT04776148?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04776148 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.