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

  • STATUS
    Recruiting
  • End date
    Mar 8, 2026
  • participants needed
    110
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 11 May 2021

Summary

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.

Details
Condition Advanced Hepatocellular Carcinoma
Treatment Pembrolizumab, Lenvatinib, Pembrolizumab/Quavonlimab
Clinical Study IdentifierNCT04740307
SponsorMerck Sharp & Dohme Corp.
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

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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