drugset / Trial / NCT04428151

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

Phase 2 Completed 408 enrolled Merck Sharp & Dohme LLC Eisai Inc. · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2020-08-06
Primary completion
2024-05-31
Completion
2025-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1250 mg/m2 Oral
Comparator Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Lenvatinib Small molecule 20 mg Oral
Comparator Lenvatinib Small molecule 24 mg Oral
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous