Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)
NCT ID: NCT04740307
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2021-03-16
2025-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pembrolizumab/Quavonlimab + Lenvatinib
Participants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered.
Pembrolizumab/Quavonlimab
Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
Lenvatinib
Lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).
Pembrolizumab
Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.
Interventions
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Pembrolizumab/Quavonlimab
Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
Lenvatinib
Lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).
Pembrolizumab
Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Has an active infection requiring systemic therapy, with the exception of HBV or Hepatitis C virus (HCV)
* Has a known history of human immunodeficiency virus (HIV) infection
* Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection (anti-HCV antibody \[Ab\] positive and detectable HCV RNA) at study entry
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participants ability to cooperate with the requirements of the study
* Has had an allogenic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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)
Napoli, , 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
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0247)
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0246)
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Bundang Hospital-Medical Oncology ( Site 0290)
Seongnam, Kyonggi-do, South Korea
Samsung Medical Center ( Site 0288)
Seoul, Kyonggi-do, South Korea
Asan Medical Center ( Site 0289)
Seoul, , South Korea
Hospital Universitario Central de Asturias-Hepatology ( Site 0309)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 0310)
Barcelona, , Spain
Hôpitaux Universitaires de Genève (HUG) ( Site 0335)
Geneva, Canton of Geneva, Switzerland
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 0334)
Sankt Gallen, Canton of St. Gallen, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 0333)
Lausanne, Canton of Vaud, Switzerland
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 0332)
Zurich, Canton of Zurich, Switzerland
Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin ( Site 0331)
Bern, , Switzerland
NATIONAL CHENG-KUNG UNI. HOSP.-Clinical Trial Research Team of Liver Diseases ( Site 0354)
Tainan City, , Taiwan
National Taiwan University Hospital-Oncology ( Site 0351)
Taipei, , Taiwan
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
Taipei, , Taiwan
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1308A-004
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2061210033
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505698-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1292-3158
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004490-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1308A-004
Identifier Type: -
Identifier Source: org_study_id
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