A Phase III Study of Lenvatinib plus Pembrolizumab Immunotherapy Versus Standard Chemotherapy in Women with Advanced Endometrial Cancer

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Full Title

A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with Advanced Endometrial Cancer (WIRB)

Purpose

In this study, researchers are comparing the effectiveness of lenvatinib plus pembrolizumab immunotherapy with standard chemotherapy in women with advanced endometrial (uterine lining) cancer. 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.

Patients in this study will be randomly assigned to receive either:

  • Lenvatinib and pembrolizumab
  • Physician’s choice of standard chemotherapy (doxorubicin or paclitaxel)

Lenvatinib is already approved for treating thyroid and kidney cancer, and pembrolizumab is approved for treating several cancers. Their use in this study is considered investigational. Lenvatinib is taken orally (by mouth), while pembrolizumab, doxorubicin, and paclitaxel are 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 advanced, recurrent, or metastatic endometrial cancer that persists despite one prior regimen of platinum-containing chemotherapy.
  • At least 4 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients may not have received prior immunotherapy or drugs that inhibit tumor blood vessel development.
  • 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 women 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

18-517

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators