A Phase II Study of Lenvatinib and Pembrolizumab Immunotherapy in Patients with Recurrent or Persistent Endometrial or Kidney Cancer

Full Title

A Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the drugs lenvatinib and pembrolizumab in patients with endometrial (uterine lining) or renal cell (kidney) cancer that came back or has continued to grow despite prior therapy. Lenvatinib works by inhibiting the growth of the blood vessels that tumors need to grow and spread. Pembrolizumab is a form of immunotherapy. It works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells.

Lenvatinib is already approved for treating thyroid and kidney cancer, and pembrolizumab is approved for treating advanced melanoma and some non-small cell lung cancers. Their use together in this study is considered investigational. Lenvatinib is taken orally (by mouth), while pembrolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have renal cell or endometrial cancer that continued to grow or came back despite no more than two prior regimens of therapy.
  • At least 4 weeks must pass between completion of prior therapy and entry into the study.
  • Patients may not have had prior treatment that included lenvatinib or a PD-1 inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.

Protocol

15-234

Phase

I/II

Investigator

Co-Investigators

Locations