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)

Active:	No
Cancer Type:	Head and Neck Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT04428151
Trial Phases:	Phase II	Protocol IDs:	7902-009 (primary) NCI-2020-04563 2019-000569-19 E7080-G000-228 LEAP-009 MK-7902-009
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Merck Sharp & Dohme LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04428151

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.

Objectives

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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.