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)
Public ClinicalTrials.gov record NCT04776148. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized Study of Lenvatinib in Combination With Pembrolizumab Versus Standard of Care in Participants With Metastatic Colorectal Cancer Who Have Received and Progressed On or After or Became Intolerant to Prior Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04776148
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 563 participants
Conditions and interventions
Conditions
Interventions
- pembrolizumab Drug
- lenvatinib Drug
- regorafenib Drug
- TAS-102 (trifluridine and tipiracil) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 28, 2021
- Primary completion
- Sep 26, 2024
- Completion
- Sep 26, 2024
- Last update posted
- Feb 4, 2026
2021 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Cancer Care ( Site 0031) | Monterey | California | 93940 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021) | Marietta | Georgia | 30060 | — |
| University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P | Chicago | Illinois | 60637 | — |
| MFSMC-HJWCI-Oncology Research ( Site 0012) | Baltimore | Maryland | 21237 | — |
| MedStar Good Samaritan Hospital-Oncology Research ( Site 0038) | Baltimore | Maryland | 21239 | — |
| Henry Ford Hospital ( Site 0024) | Detroit | Michigan | 48202 | — |
| St. Vincent Frontier Cancer Center ( Site 0005) | Billings | Montana | 59102 | — |
| Providence Portland Medical Center ( Site 0019) | Portland | Oregon | 97213 | — |
| Thomas Jefferson University - Clinical Trials Office ( Site 0027) | Philadelphia | Pennsylvania | 19107 | — |
| Inova Schar Cancer Institute ( Site 0022) | Fairfax | Virginia | 22031 | — |
| Blue Ridge Cancer Care ( Site 0036) | Roanoke | Virginia | 24014 | — |
| Northwest Medical Specialties, PLLC ( Site 0033) | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 83 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04776148, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04776148 live on ClinicalTrials.gov.