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Immunotherapy-Targeted therapy combo shows promise for advanced liver cancer

NCT ID NCT04740307

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This clinical trial is testing a combination of two drugs—an immunotherapy (pembrolizumab/quavonlimab) and a targeted therapy (lenvatinib)—as a first treatment for people with advanced hepatocellular carcinoma, a type of liver cancer that cannot be removed by surgery. The study aims to see if this combination is safe and can shrink tumors. Participants receive the drugs intravenously and orally, and researchers monitor side effects and tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab/quavonlimab (immunotherapy) plus lenvatinib (targeted therapy)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced liver cancer, potentially shrinking tumors and extending life.
What could go wrong
This is a mid-stage trial with a small number of participants, so results may not apply to everyone. The combination may cause significant side effects, including immune-related reactions and liver toxicity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

116 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 hepatocellular carcinoma type 1 diabetes mellitus 12

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced hepatocellular carcinoma

Contacts and locations

Locations

  • Anhui Provincial Hospital ( Site 0113)

    Hefei, Anhui, 230071, China

  • Asan Medical Center ( Site 0289)

    Seoul, 05505, South Korea

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

    Beijing, Beijing Municipality, 100142, China

  • Blue Ridge Cancer Care ( Site 0008)

    Roanoke, Virginia, 24014, United States

  • CHUV (centre hospitalier universitaire vaudois) ( Site 0333)

    Lausanne, Canton of Vaud, 1011, Switzerland

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

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Charleston Oncology ( Site 0003)

    Charleston, South Carolina, 29414, United States

  • City of Hope Comprehensive Cancer Center ( Site 0002)

    Duarte, California, 91010, United States

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

    Fuzhou, Fujian, China

  • Hiroshima University Hospital ( Site 0156)

    Hiroshima, 734-8551, Japan

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

    Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias-Hepatology ( Site 0309)

    Oviedo, Principality of Asturias, 33011, Spain

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

    Shanghai, Shanghai Municipality, 200040, China

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

    Rozzano, Milano, 20089, Italy

  • Hunan Cancer Hospital-intervention department ( Site 0109)

    Changsha, Hunan, 410013, China

  • Hôpitaux Universitaires de Genève (HUG) ( Site 0335)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Icahn School of Medicine at Mount Sinai ( Site 0009)

    New York, New York, 10029, United States

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

    Bern, 3010, Switzerland

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

    Naples, 80131, Italy

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

    Baltimore, Maryland, 21287, United States

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

    Sayama, Osaka, 589-8511, Japan

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

    Tainan, 704, Taiwan

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

    Warsaw, Masovian Voivodeship, 02-034, Poland

  • National Cancer Center Hospital East ( Site 0153)

    Kashiwa, Chiba, 2778577, Japan

  • National Taiwan University Hospital-Oncology ( Site 0351)

    Taipei, 10002, Taiwan

  • Oregon Health and Science University ( Site 0006)

    Portland, Oregon, 97239, United States

  • Ospedale San Raffaele-Oncologia Medica ( Site 0227)

    Milan, 20132, Italy

  • Samsung Medical Center ( Site 0288)

    Seoul, Kyonggi-do, 06351, South Korea

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

    Seongnam, Kyonggi-do, 13620, South Korea

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

    Guangzhou, Guangdong, 510515, China

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

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

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

    Taipei, 112201, Taiwan

  • The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit

    Xi'an, Shaanxi, 710061, China

  • Toranomon Hospital Kajigaya ( Site 0154)

    Kawasaki, Kanagawa, 213-8587, Japan

  • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 0332)

    Zurich, Canton of Zurich, 8091, Switzerland

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

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Virginia Mason Medical Center ( Site 0004)

    Seattle, Washington, 98101, United States

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

    Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

  • Wuhan Union Hospital Cancer Center ( Site 0108)

    Wuhan, Hubei, 430022, China

  • Zhongshan Hospital,Fudan University ( Site 0103)

    Shanghai, Shanghai Municipality, 200032, China

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