Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Official Title

A Multicentre, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

Summary:

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Health-Related Quality of Life (HRQoL) Score Using the European Organization for Research and Treatment (EORTC) Quality of Life (QoL) Questionnaire (QLQ-C30) Version 3.0
  • Number of Participants With Adverse Events (AE)
  • Number of Participants With Serious Adverse Events (SAE)
  • Number of Participants With Immune-related Adverse Events (irAE)
  • Number of Participants With Treatment Discontinuations Due to AEs
  • Time to Treatment Failure (TTF) Due to Treatment Emergent AEs
  • Area Under the Concentration time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-∞)
  • Apparent Total Body Clearance (Cl/F) of Lenvatinib
  • Apparent Total Body Volume of Distribution (Vd/F) of Lenvatinib

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society