A Phase III Study of Pembrolizumab Immunotherapy, Lenvatinib, and Chemotherapy versus Standard Treatment as Initial Therapy for Metastatic Esophageal Cancer

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Full Title

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK 3475) + Lenvatinib (E7080/MK 7902) + Chemotherapy Compared with Standard of Care as First-line Intervention in Participants with Metastatic Esophageal Carcinoma (LEAP-014) (WIRB)

Purpose

The purpose of this study is to see if adding lenvatinib to pembrolizumab immunotherapy and chemotherapy is more effective than immunotherapy and chemotherapy alone as initial treatment for people with metastatic esophageal squamous cell cancer. Participants in this study will be randomly assigned to receive pembrolizumab and combination chemotherapy with or without lenvatinib.

Pembrolizumab boosts the power of the immune system to detect and destroy cancer cells. Lenvatinib blocks proteins called tyrosine kinases which help cells grow and develop new blood vessels. Inhibiting these proteins may slow the growth of cancer cells and cut off the blood supply that feeds them. Lenvatinib is taken orally (by mouth) and the other medications used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have metastatic esophageal squamous cell cancer that has not yet been treated.
  • Patients may not have previously received immunotherapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact the office of Dr. Geoffrey Ku at 646-888-5418

Protocol

22-325

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators