Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
Public ClinicalTrials.gov record NCT04428151. 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 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse. The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.
Study identification
- NCT ID
- NCT04428151
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 408 participants
Conditions and interventions
Conditions
Interventions
- Lenvatinib Drug
- Pembrolizumab Biological
- Docetaxel Drug
- Capecitabine Drug
- Paclitaxel Drug
- Cetuximab Drug
Drug · Biological
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
- Aug 6, 2020 (Actual)
- Primary completion
- May 31, 2024 (Actual)
- Completion
- Oct 30, 2025 (Actual)
- Last update posted
- Dec 4, 2025
2020 – 2025
United States locations
- U.S. sites
- 55
- U.S. states
- 31
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope ( Site 1519) | Duarte | California | 91010 | — |
| UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568) | Los Angeles | California | 90095 | — |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 1505) | New Haven | Connecticut | 06510 | — |
| Georgetown University Medical Center ( Site 1520) | Washington D.C. | District of Columbia | 20007 | — |
| UF Health ( Site 1554) | Gainesville | Florida | 32608 | — |
| Mid Florida Hematology and Oncology Center ( Site 1606) | Orange City | Florida | 32763 | — |
| Cleveland Clinic Florida ( Site 1596) | Weston | Florida | 33331 | — |
| Georgia Cancer Center at Augusta University ( Site 1575) | Augusta | Georgia | 30912 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521) | Marietta | Georgia | 30060 | — |
| Memorial Health University Medical Center ( Site 1626) | Savannah | Georgia | 31404 | — |
| Beacon Cancer Care ( Site 1599) | Post Falls | Idaho | 83854 | — |
| Rush University Medical Center ( Site 1560) | Chicago | Illinois | 60607 | — |
| NorthShore University HealthSystem - Evanston Hospital ( Site 1614) | Evanston | Illinois | 60201 | — |
| IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612) | Muncie | Indiana | 47303 | — |
| University of Iowa ( Site 1572) | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center ( Site 1538) | Westwood | Kansas | 66205 | — |
| Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601) | Louisville | Kentucky | 40205 | — |
| Mercy Health-Paducah Cancer Center ( Site 1623) | Paducah | Kentucky | 42003 | — |
| Our Lady of the Lake RMC-Clinical Research ( Site 1624) | Baton Rouge | Louisiana | 70808 | — |
| Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622) | Baton Rouge | Louisiana | 70809 | — |
| University of Maryland Greenebaum Cancer Center ( Site 1522) | Baltimore | Maryland | 21201 | — |
| Boston Medical Center ( Site 1605) | Boston | Massachusetts | 02118 | — |
| University of Massachusetts Chan Medical School ( Site 1616) | Worcester | Massachusetts | 01655 | — |
| VA Ann Arbor Healthcare System ( Site 1584) | Ann Arbor | Michigan | 48105 | — |
| Barbara Ann Karmanos Cancer Institute ( Site 1566) | Detroit | Michigan | 48201 | — |
| Henry Ford Health System ( Site 1544) | Detroit | Michigan | 48202 | — |
| Hattiesburg Clinic ( Site 1515) | Hattiesburg | Mississippi | 39401 | — |
| Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625) | Jackson | Mississippi | 39202 | — |
| Washington University School of Medicine ( Site 1500) | St Louis | Missouri | 63110 | — |
| St. Vincent Frontier Cancer Center ( Site 1507) | Billings | Montana | 59102 | — |
| University Of Nebraska Medical Center ( Site 1570) | Omaha | Nebraska | 68105 | — |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627) | Omaha | Nebraska | 68130 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555) | Hackensack | New Jersey | 07601 | — |
| Rutgers Cancer Institute of New Jersey ( Site 1523) | New Brunswick | New Jersey | 08901 | — |
| Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597) | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center ( Site 1582) | New York | New York | 10016 | — |
| Levine Cancer Institute ( Site 1590) | Charlotte | North Carolina | 28204 | — |
| Duke Cancer Institute ( Site 1541) | Durham | North Carolina | 27710 | — |
| University of Cincinnati Medical Center ( Site 1567) | Cincinnati | Ohio | 45219 | — |
| University Hospital Cleveland ( Site 1578) | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Main ( Site 1598) | Cleveland | Ohio | 44195 | — |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 1558) | Columbus | Ohio | 43210 | — |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508) | Tulsa | Oklahoma | 74146 | — |
| Gettysburg Cancer Center ( Site 1594) | Gettysburg | Pennsylvania | 17325 | — |
| Penn State Hershey Medical Center ( Site 1561) | Hershey | Pennsylvania | 17033 | — |
| Fox Chase Cancer Center ( Site 1502) | Philadelphia | Pennsylvania | 19111 | — |
| Medical University of South Carolina ( Site 1579) | Charleston | South Carolina | 29425 | — |
| St Francis Cancer Center-Research Office ( Site 1607) | Greenville | South Carolina | 29607 | — |
| The Center For Cancer And Blood Disorders ( Site 1569) | Fort Worth | Texas | 76104 | — |
| Utah Cancer Specialists ( Site 1621) | Salt Lake City | Utah | 84106 | — |
| Huntsman Cancer Institute ( Site 1532) | Salt Lake City | Utah | 84112 | — |
| Inova Schar Cancer Institute ( Site 1550) | Fairfax | Virginia | 22031-4867 | — |
| Hematology Oncology Associates of Fredericksburg ( Site 1537) | Fredericksburg | Virginia | 22408 | — |
| MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609) | Tacoma | Washington | 98405 | — |
| Medical College of Wisconsin Clinical Cancer Center ( Site 1574) | Milwaukee | Wisconsin | 53226 | — |
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 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04428151, 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 Dec 4, 2025 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04428151 live on ClinicalTrials.gov.