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

Official 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)

Summary:

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 Tumours 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).

Trial Description

Primary Outcome:

• Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
• Overall Survival (OS)

• Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR)
• Change from baseline in the global score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR and in all-comer participants
• Percentage of participants experiencing an adverse event (AE)
• Percentage of participants experiencing a serious adverse event (SAE)
• Percentage of participants experiencing an immune-related AE (irAE)
• Percentage of participants discontinuing from study treatment due to an AE(s)
• Plasma clearance of lenvatinib versus time
• Area under the plasma concentration-time curve (AUC) of lenvatinib
• Plasma concentration of lenvatinib

View this trial on ClinicalTrials.gov