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NCT04428151 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
- 20
- Study locations
NCT04428151: Completed Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Merck Sharp & Dohme.
NCT04428151 is a Phase 2 study of Squamous Cell Carcinoma of Head and Neck that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 408 participants, above the 159-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (157% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04428151, a Phase 2 study of Squamous Cell Carcinoma of Head and Neck, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
OS was defined as the time from randomization to death due to any cause.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Docetaxel
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Lenvatinib
Study Locations (20)
Florida
- UF Health ( Site 1554) - Gainesville
- Mid Florida Hematology and Oncology Center ( Site 1606) - Orange City
- Cleveland Clinic Florida ( Site 1596) - Weston
Georgia
- Georgia Cancer Center at Augusta University ( Site 1575) - Augusta
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521) - Marietta
- Memorial Health University Medical Center ( Site 1626) - Savannah
California
- City of Hope ( Site 1519) - Duarte
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568) - Los Angeles
Illinois
- Rush University Medical Center ( Site 1560) - Chicago
- NorthShore University HealthSystem - Evanston Hospital ( Site 1614) - Evanston
Kentucky
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601) - Louisville
- Mercy Health-Paducah Cancer Center ( Site 1623) - Paducah
Louisiana
- Our Lady of the Lake RMC-Clinical Research ( Site 1624) - Baton Rouge
- Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622) - Baton Rouge
Connecticut
- Yale-New Haven Hospital-Yale Cancer Center ( Site 1505) - New Haven
District of Columbia
- Georgetown University Medical Center ( Site 1520) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2025-10-30 |
| Phase | Phase 2 |
What the finished NCT04428151 record still lists
NCT04428151 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, above the 159-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (157% higher).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04428151 names 20 study sites across 12 states, led by Florida, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT04428151 about?
NCT04428151 is a clinical study titled "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)". 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 im...
What is the current status of trial NCT04428151?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2020-08-06. Estimated completion is 2025-10-30.
What conditions does trial NCT04428151 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT04428151?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Docetaxel (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT04428151?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04428151 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04428151's enrollment target sits among peer trials
408 5th of 37 higher than 33 of 37 other Squamous Cell Carcinoma of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck 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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