A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: lenvatinib; pembrolizumab (200 mg)
Intervention description: 4 mg capsules; 30-minute intravenous infusion
Intervention MeSH terms: Pembrolizumab; Lenvatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatocellular carcinoma; E7080; lenvatinib; pembrolizumab; Japan

Summary:

      This is an open-label Phase 1b study designed to evaluate the tolerability and safety of
      lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma
      (HCC). The study will evaluate objective response rate and duration of response by modified
      Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation
      Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of hepatocellular carcinoma (HCC)

          -  HCC for which no other appropriate therapy is available. Note: Expansion Part: No
             prior systemic therapy for advanced/unresectable HCC

          -  Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based
             on Barcelona Clinic Liver Cancer (BCLC) staging system

          -  At least 1 measurable target lesion according to modified Response Evaluation Criteria
             in Solid Tumors (mRECIST)

          -  Child-Pugh score A

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1

          -  Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal
             limits. (control by thyroid replacement therapy is acceptable.) Participants with T3,
             free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible

          -  Adequately controlled blood pressure

          -  Adequate renal function

          -  Adequate bone marrow function

          -  Adequate blood coagulation function

          -  Adequate liver function

          -  Males or females age ≥ 18 years at the time of informed consent

          -  Voluntary agreement to provide written informed consent and the willingness and
             ability to comply with all aspects of the protocol

        Exclusion Criteria:

          -  Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

          -  Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or
             squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the
             past 36 months

          -  Any medical or other condition which, in the opinion of the investigator, would
             preclude participation in a clinical trial

          -  Active infection (any infection requiring systemic treatment). Hepatitis B or C
             [HBV/HCV] is allowed

          -  Participants with CNS metastases are not eligible, unless they have completed local
             therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have
             discontinued the use of corticosteroids for this indication for at least 4 weeks
             before starting treatment in this study. Any signs (eg, radiologic) or symptoms of
             brain metastases must be stable for at least 4 weeks before starting study treatment