19-004 - Comparing Dual Medications Versus Chemotherapy for Endometrial Carcinoma
Status: openA 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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If you have questions about this trial or are interested in participating, please contact this Clinical Trial’s Coordinator by email at clinical.trials@health.southalabama.edu.
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
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Jennifer M. Scalici, M.D.Gynecologic OncologistChief of Gynecologic Oncology Service; Professor of Interdisciplinary Clinical Oncology; Director of Gynecologic Oncology Research Laboratory