Solid Tumors
Conditions
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically and/or cytologically confirmed selected solid tumor types. The selected tumor types are: non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma (excluding uveal melanoma) (2)At least 1 measurable target lesion (3)Participants must have an Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) of 0 to 1. (4)Adequately controlled blood pressure . (5)Adequate renal function (6)Adequate bone marrow function: (7)Adequate blood coagulation function (8)Adequate liver function (9)Life expectancy of 12 weeks or more
Exclusion criteria
Exclusion criteria: (1)Prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs. (2)Biologic response modifiers within 4 weeks before study entry. (3)Participants having >=2+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. (4)Prolongation of QTc (Fridericia formula) interval to >480 milliseconds (ms) (5)Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. (6)Active infection (any infection requiring systemic treatment) (7)Participant is known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C (8)History of organ allograft. (9)Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. (10)Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or has a history of interstitial lung disease. (11)Has received a live-virus vaccination within 30 days of planned treatment start. (12)Females who are breastfeeding or pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety related endpoints including dose-limiting toxicity (DLT) of lenvatinib and pembrolizumab during Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics Objective response rate (ORR) Duration of response (DOR) Pharmacokinetic (PK) profile of lenvatinib and pembrolizumab Serum antidrug antibody (ADA) | — |
Countries
Japan
Outcome results
None listed