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

Completed · Phase 2

Conditions studied: Advanced Hepatocellular Carcinoma

In brief

The purpose of this study is to evaluate the safety and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed.

Key facts

Study ID

NCT04740307

Run by

Merck Sharp & Dohme LLC

People needed

116

Starts

2021-03-16

Expected to finish

2025-07-29

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has an HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)
• Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
• Has a Child-Pugh class A liver score within 7 days prior to first dose of study intervention.
• Has a predicted life expectancy of >3 months
• Has at least 1 measurable HCC lesion based on RECIST 1.1, confirmed by BICR
• Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 7 days prior to first dose of study intervention.
• Participants with controlled hepatitis B will be eligible as long as they meet the following criteria: antiviral therapy for Hepatitis B virus (HBV) must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study drug
• Has adequately controlled blood pressure with or without antihypertensive medications
• Has adequate organ function.

You may not qualify if…

• Has had esophageal or gastric variceal bleeding within the last 6 months.
• Has bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring therapeutic international normalized ratio (INR) monitoring, e.g., warfarin or similar agents
• Has clinically apparent ascites on physical examination
• Has inferior vena cava or cardiac involvement of HCC based on imaging
• Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy
• Has medical contraindications that preclude all forms of contrast-enhanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
• Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
• Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula
• Has clinically active hemoptysis (bright red blood of a least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug
• Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
• Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention
• Has had a minor surgery (i.e., simple excision) within 7 days prior to the first dose of study intervention (Cycle 1 Day 1)
• Has serious nonhealing wound, ulcer, or bone fracture
• Has received any systemic chemotherapy, including anti- vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agents for treatment of HCC
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
• Has received locoregional therapy to liver within 4 weeks prior to the first dose of study intervention
• Has received prior radiotherapy to a non-liver region within 2 weeks of start of study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis as assessed by local site investigator
• Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of their excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Where it is running

• City of Hope Comprehensive Cancer Center ( Site 0002) — Duarte, California, United States
• Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013) — Baltimore, Maryland, United States
• Icahn School of Medicine at Mount Sinai ( Site 0009) — New York, New York, United States
• Oregon Health and Science University ( Site 0006) — Portland, Oregon, United States
• Charleston Oncology ( Site 0003) — Charleston, South Carolina, United States
• Blue Ridge Cancer Care ( Site 0008) — Roanoke, Virginia, United States
• Virginia Mason Medical Center ( Site 0004) — Seattle, Washington, United States
• Anhui Provincial Hospital ( Site 0113) — Hefei, Anhui, China
• Beijing Cancer hospital-Department of Hepato-Pancreato-Biliary Surgery II ( Site 0107) — Beijing, Beijing Municipality, China
• Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 0105) — Fuzhou, Fujian, China
• Southern Medical University Nanfang Hospital-Liver Cancer Department ( Site 0106) — Guangzhou, Guangdong, China
• Wuhan Union Hospital Cancer Center ( Site 0108) — Wuhan, Hubei, China
• Hunan Cancer Hospital-intervention department ( Site 0109) — Changsha, Hunan, China
• The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit — Xi'an, Shaanxi, China
• Zhongshan Hospital,Fudan University ( Site 0103) — Shanghai, Shanghai Municipality, China
• Huashan Hospital Affiliated Fudan University-Surgery Department ( Site 0118) — Shanghai, Shanghai Municipality, China
• Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0231) — Rozzano, Milano, Italy
• Ospedale San Raffaele-Oncologia Medica ( Site 0227) — Milan, Italy
• Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0230) — Naples, Italy
• National Cancer Center Hospital East ( Site 0153) — Kashiwa, Chiba, Japan
• Toranomon Hospital Kajigaya ( Site 0154) — Kawasaki, Kanagawa, Japan
• Kindai University Hospital- Osakasayama Campus-Department of Gastroenterology and Hepatology ( Site — Sayama, Osaka, Japan
• Hiroshima University Hospital ( Site 0156) — Hiroshima, Japan
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site — Warsaw, Masovian Voivodeship, Poland
• Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu ( Site 0249) — Przemyśl, Podkarpackie Voivodeship, Poland

Full record on ClinicalTrials.gov

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