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) (LEAP-10)

  • STATUS
    Not Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    500
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 8 August 2022
cancer
measurable disease
squamous cell carcinoma
pembrolizumab
primary tumor
oropharyngeal
caries
mk-3475
metastatic head and neck squamous cell carcinoma

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).

Details
Condition Head and Neck Squamous Cell Carcinoma
Treatment Placebo, Pembrolizumab, Lenvatinib
Clinical Study IdentifierNCT04199104
SponsorMerck Sharp & Dohme LLC
Last Modified on8 August 2022

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