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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: Completed Phase 3 study of Colorectal Neoplasms, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OS was defined as the time from randomization to the date of death from any cause. Per the supplemental Statistical Analysis Plan (sSAP), Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023.
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 |
What the finished NCT04776148 record still lists
NCT04776148 is an interventional study that assigns participants to a tested intervention. The registered 563 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target.
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
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Where NCT04776148's enrollment target sits among peer trials
563 12th of 54 higher than 43 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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