A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

Active:	No
Cancer Type:	Head and Neck Cancer Unknown Primary	NCT ID:	NCT04199104
Trial Phases:	Phase III	Protocol IDs:	7902-010 (primary) MK-7902-010 NCI-2020-00576 2019-003717-34 205240 LEAP-10
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Merck Sharp & Dohme LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04199104

Summary

This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a
first line intervention in a PD-L1 selected population with participants with recurrent or
metastatic head and neck squamous cell carcinoma.

Hypotheses include:

- Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST 1.1) by blinded independent central review (BICR).

- Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.

- Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
overall survival (OS).

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