19-004 - Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

Status: open

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)

Patients with Endometrial Carcinoma

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Description

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).

Sponsors

This trial is sponsored by Merck.

Providers Associated With This Trial

  • Rocconi RodneyView Profile
    Rodney P. Rocconi, M.D., F.A.C.O.G.Gynecologic OncologistInterim Director of Mitchell Cancer Institute; Associate Director for Clinical Research; Abraham A. Mitchell Clinical Cancer Research Scholar; Professor of Interdisciplinary Clinical Oncology

Sub Investigators

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