Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
This is a phase II non-randomized, multi-center study. The primary end point of this study is
the objective response rate (ORR) at 24 weeks, using response evaluation criteria for solid
tumors (RECIST) 1.1 criteria, for the combination therapy of continuous daily oral lenvatinib
with three-weekly intravenous pembrolizumab in patients with recurrent clear cell carcinoma
of gynecological origin (CCGC). The statistical design is Simon's minimax two-stage design
and the present study aims to complete stage 1 of the Simon's two-stage design.