Trial Details 98 Total Sites

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)

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).

phase

Phase 3

status

Recruiting

enrollment

500

score

52

start date

2020-02-05

last updated

2022-01-19

biomarkers

N/A

Detroit, Michigan
facility
Henry Ford Health System ( Site 0001)
facility
Karmanos Cancer Institute ( Site 0054)
2 facilities
Recruiting
Boston, Massachusetts
facility
Dana Farber Cancer Institute ( Site 0019)
1 facility
Recruiting
Portland, Oregon
facility
Providence Portland Medical Center ( Site 0048)
1 facility
Recruiting
Omaha, Nebraska
facility
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)
1 facility
Recruiting
Aurora, Colorado
facility
University of Colorado Cancer Center ( Site 0023)
1 facility
Recruiting
St. Louis, Missouri
facility
Washington University School of Medicine ( Site 0060)
1 facility
Recruiting
Durham, North Carolina
facility
Duke Cancer Center ( Site 0044)
1 facility
Recruiting
Madison, Wisconsin
facility
University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)
1 facility
Recruiting
Louisville, Kentucky
facility
University of Louisville, James Graham Brown Cancer Center ( Site 0045)
1 facility
Recruiting
Hollywood, Florida
facility
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)
1 facility
Recruiting
Syracuse, New York
facility
SUNY Upstate Medical University ( Site 0051)
1 facility
Recruiting
Ann Arbor, Michigan
facility
University of Michigan ( Site 0064)
1 facility
Recruiting