A phase 1b trial of lenvatinib (LEN) plus pembrolizumab (PEM) in patients with selected solid tumors

Abstract

Methods: The study enrolled pts aged ≥18 y with histologically and/or cytologically confirmed metastatic selected solid tumors that progressed after approved therapies or for which no standard effective therapies were available. Pts received 200 mg PEM IV once every 3 wks, and 1 of 2 LEN dose levels (DL) PO (DL1: 24 mg/d; DL2: 20 mg/d). Primary endpoint was maximum tolerated dose (MTD); key secondary endpoints were safety, tolerability, and objective response rate (ORR) per irRECIST. Tumor assessments were performed every 6 wks until wk 24, then every 9 wks.