Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

Official Title

A Phase 3 Multicentre, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)

Summary:

The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Percentage of Participants Who Experience At Least One Adverse Event (AE)
  • Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
  • Percentage of Participants Who Experience At Least One Immune-related Adverse Event (irAE) of Clinical Interest
  • Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
  • Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
  • Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf)
  • Time to Disease Progression (TTP) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Progression-free Survival (PFS) per Modified Response Evaluation Criteria in Solid Tumours (mRECIST)
  • Objective Response Rate (ORR) per Modified Response Evaluation Criteria in Solid Tumours (mRECIST)
  • Duration of Response (DOR) per Modified Response Evaluation Criteria in Solid Tumours (mRECIST)
  • Disease Control Rate (DCR) per Modified Response Evaluation Criteria in Solid Tumours (mRECIST)
  • Time to Disease Progression (TTP) per Modified Response Evaluation Criteria in Solid Tumours (mRECIST)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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