A Phase III Study of Pembrolizumab Immunotherapy plus Lenvatinib versus Chemotherapy as Initial Treatment for Advanced or Recurrent Endometrial Carcinoma

Full Title

A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001) (WIRB)

Purpose

Chemotherapy drugs such as carboplatin and paclitaxel are standard treatments for advanced endometrial cancer. In this study, researcher are comparing combination therapy with pembrolizumab immunotherapy plus lenvatinib with standard chemotherapy in women with advanced or recurrent endometrial cancer.

Lenvatinib works by inhibiting the growth of the blood vessels that tumors need to grow and spread. Pembrolizumab 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 several cancers. Their use together in this study is considered investigational.

Patients will be randomly assigned to receive pembrolizumab/lenvatinib OR carboplatin/paclitaxel. Lenvatinib is taken orally (by mouth), while pembrolizumab, carboplatin 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 stage III/IV recurrent or metastatic endometrial cancer.
  • Prior chemotherapy is permitted if it was given with radiation therapy.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • 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

19-144

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators