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MK-7902-002 (LEAP-002): A phase 3, multicenter, randomized, double-blinded, active-controlled, clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus lenvatinib in first-line therapy of participants with advanced hepatocellular carcinoma

Description

The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.

Status

Accepting new patients

Primary Study Objective(s)

To compare progression-free survival (PFS) and overall survival (OS).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are 18 years of age or older at the time of signing the informed consent
  • Have a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
  • Have 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
  • Have a Child-Pugh class A liver score
  • Have a predicted life expectancy of more than three months
  • Have at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1 as confirmed by BICR
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1

Note: Participants with hepatitis B will be eligible as long as their virus is well controlled.

Excluding patients who:

  • Have had esophageal or gastric variceal bleeding within the last six months
  • Have gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
  • Have a preexisting grade ≥3 gastrointestinal or non-gastrointestinal fistula
  • Have clinically significant hemoptysis from any source or tumor bleeding within two weeks prior to the first dose of study intervention
  • Have significant cardiovascular impairment within 12 months of the first dose of study intervention such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability
  • Have had major surgery to the liver within four weeks prior to the first dose of study intervention
  • Have had a minor surgery (ie, simple excision) within seven days prior to the first dose of study intervention
  • Have serious non-healing wound, ulcer, or bone fracture
  • Have received any systemic chemotherapy for HCC or chemotherapy for any malignancy in the past three years
  • Have received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, or CD137)
  • Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior the first dose of study intervention
  • Have a known additional malignancy that is progressing or has required active treatment within the past three years with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that has undergone potentially curative therapy
  • Have a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis as assessed by local site investigator
  • Have severe hypersensitivity (≥Grade 3) to study intervention and/or any of their excipients
  • Have an active autoimmune disease that has required systemic treatment in past two years
  • Have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Have urine protein ≥1 grams/24 hours
  • Have prolongation of corrected QT (QTc) interval to >480 milliseconds (corrected by Fridericia Formula)
  • Have left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
  • Have an active infection requiring systemic therapy with the exceptions of hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Have a known history of human immunodeficiency virus (HIV) infection
  • Have known active tuberculosis (Bacillus tuberculosis)
  • Have 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
  • Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
  • Have had an allogenic tissue/solid organ transplant
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Arturo Loaiza-Bonilla