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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 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.

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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.

Conditions Studied

Squamous Cell Carcinoma of Head and Neck

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

FieldValue
Enrollment Target 408 participants
Start Date 2020-08-06
Est. Completion 2025-10-30
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04428151

The ClinicalTrials.gov registry entry for NCT04428151 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 159-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (157% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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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.