Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Co., Ltd.
With
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
