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)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

With Amendment 7, participants will discontinue lenvatinib and pembrolizumab and lenvatinib monotherapy, unless discussed with the Sponsor. A protocol-specified periodic safety review was completed with a data cut-off of 31-May-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 34 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-06
• Primary completion: 2024-05-31
• Completion: 2025-10-30
• First posted: 2020-06-11
• Last updated: 2025-12-04
• Results posted: 2025-05-25

Locations

120 sites across 15 countries: United States, Australia, Brazil, Canada, Colombia, Denmark, France, Israel, Norway, Portugal, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study