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) (MK-7902-010/LEAP-010)-China Extension

PHASE3CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

October 30, 2020

Primary Completion Date

August 25, 2023

Study Completion Date

March 28, 2025

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Lenvatinib

Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD

BIOLOGICAL

Pembrolizumab

Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles

DRUG

Placebo

Lenvatinib-matching placebo, oral capsules, administered once daily (QD)

Trial Locations (28)

100032

Peking Union Medical College Hospital ( Site 3304), Bejiing

100036

Beijing Cancer Hospital ( Site 3314), Beining

100730

Beijing Tongren Hospital affiliated to Capital Medical University ( Site 3343), Beijing

130000

Jilin Cancer Hospital ( Site 3310), Changchun

150081

The Third Affiliated Hospital of Harbin Medical University ( Site 3302), Harbin

200011

Shanghai 9th People hospital ( Site 3332), Shanghai

200032

Fudan University Shanghai Cancer Center ( Site 3324), Shanghai

200120

Shanghai East Hospital ( Site 3300), Shanghai

213000

Changzhou Tumor Hospital - Changzhou Fourth People's Hospital ( Site 3339), Changzhou

230031

Anhui Cancer Hospital-Radiology Department ( Site 3333), Hefei

300060

Tianjin Medical University Cancer Hospital ( Site 3312), Tianjin

310022

Zhejiang Cancer Hospital ( Site 3303), Hangzhou

330029

Jiangxi Cancer Hospital ( Site 3313), Nanchang

350014

Fujian Provincial Cancer Hospital ( Site 3326), Fuzhou

400030

Chongqing Cancer Hospital ( Site 3327), Chongqing

410000

Hunan Cancer Hospital ( Site 3311), Changsha

410008

Xiangya Hospital of Central South University ( Site 3305), Changsha

410013

Hunan Cancer Hospital ( Site 3334), Changsha

430000

Wuhan Union hospital Cancer Center ( Site 3307), Wuhan

430030

Tongji Hospital Tongji Medical,Science & Technology ( Site 3316), Wuhan

450008

Henan Cancer Hospital ( Site 3309), Zhengzhou

510000

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3336), Guangzhou

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3338), Guangzhou

510080

The First Affiliated Hospital, Sun Yat-sen University ( Site 3344), Guangzhou

530000

Guangxi Medical University Affiliated Tumor Hospital ( Site 3322), Nanning

550003

Guizhou Cancer Hospital ( Site 3330), Guiyang

610047

West China Hospital of Sichuan University ( Site 3308), Chengdu

710000

The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328), Xi'an

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05523323 - 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) (MK-7902-010/LEAP-010)-China Extension | Biotech Hunter | Biotech Hunter