Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)

PHASE2CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

March 16, 2021

Primary Completion Date

July 29, 2025

Study Completion Date

July 29, 2025

Conditions
Advanced Hepatocellular Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab/Quavonlimab

Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.

DRUG

Lenvatinib

Lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).

BIOLOGICAL

Pembrolizumab

Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.

Trial Locations (40)

704

NATIONAL CHENG-KUNG UNI. HOSP.-Clinical Trial Research Team of Liver Diseases ( Site 0354), Tainan City

1011

CHUV (centre hospitalier universitaire vaudois) ( Site 0333), Lausanne

1211

Hôpitaux Universitaires de Genève (HUG) ( Site 0335), Geneva

3010

Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin ( Site 0331), Bern

8091

UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 0332), Zurich

9007

Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 0334), Sankt Gallen

10002

National Taiwan University Hospital-Oncology ( Site 0351), Taipei

10029

Icahn School of Medicine at Mount Sinai ( Site 0009), New York

13620

Seoul National University Bundang Hospital-Medical Oncology ( Site 0290), Seongnam

20089

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0231), Rozzano

20132

Ospedale San Raffaele-Oncologia Medica ( Site 0227), Milan

21287

Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013), Baltimore

24014

Blue Ridge Cancer Care ( Site 0008), Roanoke

29414

Charleston Oncology ( Site 0003), Charleston

33011

Hospital Universitario Central de Asturias-Hepatology ( Site 0309), Oviedo

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0230), Napoli

91010

City of Hope Comprehensive Cancer Center ( Site 0002), Duarte

97239

Oregon Health and Science University ( Site 0006), Portland

98101

Virginia Mason Medical Center ( Site 0004), Seattle

100142

Beijing Cancer hospital-Department of Hepato-Pancreato-Biliary Surgery II ( Site 0107), Beijing

112201

Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (, Taipei

200032

Zhongshan Hospital,Fudan University ( Site 0103), Shanghai

200040

Huashan Hospital Affiliated Fudan University-Surgery Department ( Site 0118), Shanghai

230071

Anhui Provincial Hospital ( Site 0113), Hefei

410013

Hunan Cancer Hospital-intervention department ( Site 0109), Changsha

430022

Wuhan Union Hospital Cancer Center ( Site 0108), Wuhan

510515

Southern Medical University Nanfang Hospital-Liver Cancer Department ( Site 0106), Guangzhou

710061

The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit, Xi'an

2778577

National Cancer Center Hospital East ( Site 0153), Kashiwa

Unknown

Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 0105), Fuzhou

213-8587

Toranomon Hospital Kajigaya ( Site 0154), Kawasaki

589-8511

Kindai University Hospital- Osakasayama Campus-Department of Gastroenterology and Hepatology ( Site, Sayama

734-8551

Hiroshima University Hospital ( Site 0156), Hiroshima

02-034

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site, Warsaw

37-700

Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu ( Site 0249), Przemyśl

80-952

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0247), Gdansk

75-581

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0246), Koszalin

06351

Samsung Medical Center ( Site 0288), Seoul

05505

Asan Medical Center ( Site 0289), Seoul

08035

Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 0310), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04740307 - Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004) | Biotech Hunter | Biotech Hunter