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:	Yes
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

This study is designed to assess the safety and efficacy of lenvatinib in combination
with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the
safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic
head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum
therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1
(PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior
to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

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