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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)

NCT04428151 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-12-04

Study results available
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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

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Lenvatinib

20 mg once daily, taken as oral capsules

BIOLOGICAL

Pembrolizumab

200 mg 30-minute IV infusion on day 1 of each 21-day cycle

DRUG

Docetaxel

75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle

DRUG

Capecitabine

1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets

DRUG

Paclitaxel

80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

DRUG

Cetuximab

400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

DRUG

Lenvatinib

24 mg once daily, taken as oral capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2024-05-31
Completion
2025-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Colombia
  • Denmark
  • France
  • Israel
  • Norway
  • Portugal
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428151 on ClinicalTrials.gov